Revise - CfPA

1For course information, go to www.cfpa.comFor course information, go to www.cfpa.com

Revise contents and

additionalcourses

ADME: Fundamentals of Absorption, Distribution, Metabolism & Elimination ID: 2077 Offering #: 0803-107

March 6-7, 2008 • New Brunswick, NJWho Should Attend: This course is designed for a broad range of personnel in the pharmaceutical indus-try that need a basic understanding of ADME/pharmacokinetics, especially as pertains to drug develop-ment. It should be especially valuable for:

• Those needing a basic understanding of the processes involved in absorption and disposition of drugs • Managers of pharmacology and toxicology studies • Scientists that direct or evaluate pre-clinicalstudies • Chemists and other scientists involved in drug development • Biomedical engineers

Course Summary: The course will provide participants with an understanding of the principals and funda-mentals for absorption, distribution, metabolism, and the elimination (ADME) of pharmaceutical chemicals.The actual dose of a drug that ultimately reaches the target tissues and exerts pharmacologic or toxicologiceffects is highly dependent on the kinetics of drug absorption and disposition in the body. Many factors caninfluence these kinetic processes. The goal of the course is to provide training in the fundamentals of ADMEthat should be understood for those involved in drug development and clinical applications. The thrust of thediscussions will pertain to drugs, although the concepts are appropriate for all chemical entities. Some model-ing and mathematical formulations will be presented; however, the lack of mathematical background will notimpede one’s ability to understand the concepts involved. Finally, a few practical examples of the ADME ofdrugs will be provided to illustrate how the principles are applied in real life situations.

Course Director:Theodore M. Farber PH.D., DABT ToxaChemica, International, Inc. Former FDA Director, Drugand Environmental Toxicology Former EPA Director, Pesticide Toxicology.

Tuition:Early Registration (SAVE $200): U.S. $1275 ($1215 with Group Rate*) (Must register and pay by January 10, 2008)

Regular Registration: U.S. $1475 ($1415 with Group Rate*)

ACCREDITATIONS/CERTIFICATIONSThe Center for Professional Advancement(CfPA) is accredited by the AccreditationCouncil for Pharmacy Education as a providerof continuing pharmacy education. Continuing

Education Units (CEU) will be awarded only upon successfulcompletion of the course, i.e., attendance at essentially all the formal sessions and submission of a course evaluation. The CEU rate is 0.1 CEU per contact hour; statement of credit will be mailed within six weeks. You will have an oppor-tunity to evaluate your successful completion of these courseobjectives through a Learning Assessment. This offering isProgram# 716-000-07-490-L04

(Please refer to page 17 for full description of each Accreditation)

Analytical Methods Validation for FDA Compliance ID: 1887 Offering #: 0803-102

March 3-5, 2008 • New Brunswick, NJWho Should Attend: This course is intended for individuals who have the responsibility for establishing theintegrity of analytical methods for active pharmaceutical ingredients (APIs) or finished pharmaceutical dosageforms. This course will benefit individuals in:• R&D • Quality Control • Technical Operations • Quality AssuranceRegulatory affairs personnel responsible for the review of such data will also benefit from this course.

Course Summary: One of the most critical factors in developing and marketing pharmaceutical drug sub-stances and drug products today is ensuring that the analytical methods used for analysis can generate validdata upon which business and regulatory decisions can be made. FDA, ICH and USP have each recognizedthe importance of this to the drug development process and have separately expanded method validationrequirements in recent years. However, with only limited guidance, industry has been left to interpret how toadequately comply with the regulations. Whether involved in method development, method validation, method optimization or method transfer, thiscourse will provide a broad understanding and “hands-on” knowledge of the method validation process andthe difficulties encountered in validating methods to comply with today’s upgraded FDA CDER requirements.Lectures will include not only theoretical basis and practical applications, but actual validation examples ofHPLC, GC, UV/Vis, AA, and titration methods for small organic molecules. Some of the more commonmathematical and statistical treatments of validation data will also be discussed. Because of the tremendouseffort that can be expended in conducting validation studies, efficiency of experimental design and documen-tation will be stressed throughout the discussions.Although the general principles in this course may be applied to methods for testing biological molecules andmedical devices, the focus of this course is on the validation of methods for the analysis of small molecules.

Course Co-Directors:J. Mark Green, Ph.D., Principal Investigator, Bristol-Myers Squibb Medical ImagingDavid E. Wiggins, Associate Director of Analytical/Stability R&D, Schering-Plough Consumer Health Care Products




Education Units (CEU) will be awarded only upon successfulcompletion of the course, i.e., attendance at essentially allthe formal sessions and submission of a course evaluation.The CEU rate is 0.1 CEU per contact hour; certificate will be mailed within six weeks. You will have an opportunity to evaluate your successful completion of these courseobjectives through a Learning Assessment. This offering is Program# 716-000-06-003-L04

This course (#07-1812)has been approved for

3.0 Certification Maintenance Points by The AmericanBoard of Industrial Hygiene (ABIH) for recertification.


Catalog ContentsTitle Date Location PageADME: Fundamentals of Absorption, Distribution, March 6-7 NJ 1Metabolism & Elimination

Analytical Methods Validation for FDA Compliance March 3-5 NJ 1

Annual Product Reviews (APRs) for Pharmaceuticals Jan 31- Feb 1 NJ 2

Applied cGMPs for Pharmaceutical & Allied Industries March 17-19 CA 2

Calibration in the FDA Regulated Industry January 28-29 NJ 3

CMC Submissions in CTD Format February 25-26 FL 3

Complaint Procedures for Medical Devices March 10-12 PR 4

Critical Process Cleaning and Cleaning Validation January 16-18 FL 4

Design Control and Product Validation January 24-25 NJ 5 for Medical Devices

Documentation Management and Control February 25-26 NJ 5

Drug Product Stability and Shelf Life March 5-7 NJ 6

Emulsion-Suspension Technology January 28-30 NJ 6

GMP for Dietary Supplements March 13-14 CA 7

Good Laboratory Practices (GLP) March 11-13 FL 7

Granulation, Tabletting & Capsule Technology March 17-20 FL 8

ICH Q10: Phamaceutical Quality System March 27-28 NJ 8

In Vitro Testing Methodologies for Safety March 17-19 NJ 9Assessment of Cosmetic Ingredients

INDs, NDAs vs CTDs Global Regulations March 10-12 CA 9

IQ/OQ/PQ March 5–6 FL 10

ISO 13485, ISO 9001 and QSR Regulations March 31–April 2 PR 10for Medical Device Companies

Microbiological Control and Validation March 12-14 NJ 11

Microencapsulation and Particle Coating February 11-13 NJ 11

Non-Clinical Drug Safety Evaluation and February 27-29 NJ 12Drug Development

PAT Online Process Analysis February 6-8 TX 12

Pilot Plant and Scale-Up Studies Process February 20-22 NJ 13Development and Scale-Up Methods

Process Validation for the Pharmaceutical and March 10-11 NJ 13Medical Device Industries

Selecting and Managing CROs February 11-12 NJ 14

Skin Product Development March 5-7 CA 14

Sterile Products: Formulation, Manufacture February 25-27 CA 15

System Validation, GAMP Harmonization and P.A.T. March 26-28 NJ 15

Technical Writing in the Pharmaceutical January 23–25 NJ 16and Allied Industries

General Information 17

January - March 2008Training for the Pharmaceutical, Clinical, Medical Device and Related Industries

NEW

WelcomeFor 40 years CfPA has been meeting theneeds of professionals in the pharmaceuti-cal, biotechnology, clinical and medicaldevice industries with the most compre-hensive selection of accredited technicaltraining programs available anywhere. Our curriculum of over 450 courses in 19 industries cover basic to advanced top-ics in Regulatory, Quality Assurance,Manufacturing, and Research. Choose acourse from a variety of formats to fit your professional lifestyle: public, clientsite or online.

We look forward to seeing you at anupcoming course.

Online TrainingCfPA’s Online Training program offers anew way to experience CfPA’s AccreditedTechnical Training and is the perfect com-plement to our public and client site courses. Now you can easily access theknowledge you need through the Internet to improve your performance on the job and increase your value to your employer. For more information on upcoming courses,visit our website at:

www.cfpa.com/onlinetraining orE-mail: [email protected]

Client Site TrainingTake advantage of the benefits Client Sitetraining offers: Cost effective, convenient,customized one-on-one attention. Anycourse in this listing can be brought to yourcompany and tailored to your specificneeds. For further information, please contact Client Site Programs:

732.238.1600 ext. 4549 or E-mail: [email protected]

Please note course topics, dates, and locations subject to change. Please refer to our website for the most current information.

2 For course information, go to www.cfpa.com 3For course information, go to www.cfpa.com

Applied cGMPs for Pharmaceutical and Allied Industries ID: 610 Offering #: 0803-301

March 17-19, 2008 • Burlingame, CAWho Should Attend: This is an ideal course to acquire current applications of cGMPs. It offers latitude fordiscussion of fundamental as well as evolving regulatory initiatives and other complex issues. The course isdistinguished for benefit to domestic as well as non-US enterprises, including the following:

Positions – Analysts, Directors, Engineers, Executives, Investigators, Internal Auditors, Managers,Operators, QA/QC, Research, Supervisors, and Trainers

Industries – Academia, Biogeneric, Biological, Biopharmaceutical, Combination Product Manufacturers,Consultants, Contract Manufacturing, Dietary Supplements, Health Care, Legal Pharmaceutical,Regulatory, and Many Others.

Course Summary: This course takes you through Current Good Manufacturing Practice (cGMP) in thepharmaceutical and allied industries. Topics covered include legal requirement for cGMP in the Federal Food,Drug, and Cosmetic Act and related regulations. It addresses practical aspects of personnel, facilities, equip-ment, components, manufacturing, laboratory, packaging, labeling and QA/QC and provides an excellentforum for training personnel in cGMPs. The faculty consists of individuals with long and distinguished experi-ence in the field. Throughout this course, the relevance of FDA inspections commonly surfaces. There isspecial emphasis on discussing procedures and practices of the regulatory agency to help firms comprehendmanagement of FDA relationships.

Course Director:Wayne A. Mazanec, Former FDA Asssistant Regional Director–Pacific Region, and Regulatory Consultant






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CMC Submissions in CTD Format ID: 1989 Offering #: 0802-506

February 25-26, 2008 • Boca Raton, FLWho Should Attend: This course is intended for all personnel in pharmaceutical companies especially those in:

• Regulatory Affairs • Pharmaceutical Development• Chemistry and Analytical Departments • QA/QC for the CMC section of the NDA/CTD• Pre-formulation

It is recommended that you have at least one year experience in either regulatory affairs, chemistry, ana-lytical, QA/QC or pharmacy department or pharmaceutical development to fully benefit from this course.

Course Summary: This course will provide an in depth review of the chemistry, manufacturing and con-trols (CMC) requirements for development and ultimate submission to the FDA and European regulatorybodies in the new drug application (NDA). Emphasis will be placed on current FDA, European and ICHrequirements for the filing of the quality section of the CTD for manufacturing, analytical, sterility and stability issues as they apply to the drug substance and drug product. In addition, details on supplementalapplications for changes to an NDA will be presented focusing on SUPAC requirements.

Course Director:Carolyn H. Kruse, MSc., M.TOPRA, Consultant to the Pharmaceutical Industry, Kruse Consulting Group

Tuition:Early Registration (SAVE $200): U.S. $1275 ($1215 with Group Rate*) (Must register and pay by December 31, 2007)


ACCREDITATIONS/CERTIFICATIONS

The Center for Professional Advancement(CfPA) is accredited by the AccreditationCouncil for Pharmacy Education as a providerof continuing pharmacy education. Continuing

Education Units (CEU) will be awarded only upon successfulcompletion of the course, i.e., attendance at essentially all the formal sessions and submission of a course evaluation.The CEU rate is 0.1 CEU per contact hour; certificate will bemailed within six weeks. You will have an opportunity to evalu-ate your successful completion of these course objectivesthrough a Learning Assessment. This offering is Program#716-000-07-313-L04


Calibration in the FDA Regulated Industry ID: 2026 Offering #: 0801-501

January 28-29, 2008 • New Brunswick, NJWho Should Attend: This overview course is intended for individuals in all industries, but specifically individuals in FDA regulated industries, who are responsible for establishing, maintaining, operating a cali-bration program, and audit of calibration activities, including:• Quality Assurance • Quality Control• Quality Engineering • Technical Support• Research and Development • Facilities and Equipment Maintenance

Course Summary: The regulations covering manufacture and control of drug products and medicaldevices require that firms have a program for the calibration of test and measurement equipment. A requirement for calibration is also defined in ISO 9000 and a Quality System for a calibration laboratoryis described in ISO 17025. Calibration is a good business and science practice followed in all industriesthat require measurements for process monitoring and control. The program must include the elementsof: calibration intervals, scheduling, specific calibration procedures, limits of accuracy and precision andremedial action in the event that the instrument does not meet established requirements.This course addresses the regulatory and business requirements for calibration as an element of a QualitySystem and how these requirements support the increasing application of process monitoring andsophisticated laboratory instrumentation, along with the maturing discipline of calibration in the regulatedindustries. It includes a discussion of a compliant calibration program and concludes with a discussion of a model calibration procedure.

Course Director:Dr. Jerry Lanese, President, The Lanese Group, Inc.




The Center for Professional Advancement(CfPA) is accredited by the AccreditationCouncil for Pharmacy Education as a providerof continuing pharmacy education. Continuing

Education Units (CEU) will be awarded only upon successfulcompletion of the course, i.e., attendance at essentially all the formal sessions and submission of a course evaluation.The CEU rate is 0.1 CEU per contact hour; certificate will bemailed within six weeks. You will have an opportunity to evalu-ate your successful completion of these course objectivesthrough a Learning Assessment. This offering is Program#716-000-07-305-L04

The American Association of Family andConsumer Sciences has approved thiscourse for 12 Professional DevelopmentUnits.


Annual Product Reviews (APRs) for Pharmaceuticals ID: 1998 Offering #: 0801-502

January 31–February 1, 2008 • New Brunswick, NJWho Should Attend: This course should benefit those who need to know how APRs for drug productsand/or active pharmaceutical ingredients should be designed, organized and otherwise managed. The course will benefit individuals in:

• Quality Assurance • Quality Control • Production• Regulatory Affairs • Technical Services • Site & Corporate Management

It should also be of interest to suppliers to the industry.

Course Summary: The FDA’s cGMP regulations require that an annual review (commonly called“Annual Product Review”) be performed for all drug products. The EU GMP regulations and also theICH Q7A guideline for the GMP’s for active pharmaceutical ingredients have corresponding detailedrequirements. In each case, there is a general requirement that the quality of each product bereviewed at least once per year “to determine the need for changes in specifications or manufacturingor control procedures” and that any adverse or unexpected trends be identified so that correctiveaction can be taken. It is indicated that the review should encompass “a representative number ofbatches” and include considerations of “recalls,” “product complaints,“ “returned & salvaged products” and “investigations” performed as a result of deviations encountered during production.The wording used is very broad and provides little guidance on what details should be addressed. This course sets out to define what details should not only satisfy the FDA’s expectations but shouldalso help meet the firms economic goals of understanding product quality & identifying areas for correction & improvement. The course includes a consideration of the system by which APRs can beeffectively and efficiently prepared and issued as well as the details which the SOP should address.

A Team Presentaion by:Dr. Alan J. Smith, Pharmaceutical Quality & Technology ConsultantDr. John G. (Jerry) Lanese, President, The Lanese Group, Inc.






Please note course topics, dates, and locations subject to change. Please refer to our website for the most current information. Please note course topics, dates, and locations subject to change. Please refer to our website for the most current information.


Critical Process Cleaning and Cleaning Validation ID: 1867 Offering #: 0801-301

January 16-18, 2008 • Boca Raton, FLWho Should Attend: This course is intended for professionals in:• Process Engineering • Production • Quality Assurance • Validation• Technical and management positionsYou should have some familiarity and experience with the basic subject as it applies to research and man-ufacturing of pharmaceuticals, personal care products, nutritional materials and fine chemicals.

Course Summary: This course will provide a solid overview of the principles and technology of residueremoval and residue measurement on product contact surfaces. It will address the latest issues, industrypractices and compliance strategies regarding choice of cleaning techniques, cleaning agents, analyticalmethods, residue challenges, grouping strategies and validation protocols. Examples of current industrycleaning validation practices and case histories will be presented. Recent FDA inspection history and regulatory comment regarding these issues will be discussed in depth.This practical course will help participants familiar with this topic to better evaluate and develop their ownFDA regulated cleaning programs that balance production objectives against QA/validation objectives.The idea is to first achieve an effective reliable cleaning process, then generate sufficient data and justifi-cation without going overboard on the number of samples, the number of analytical tests and the numberof qualification studies that have become an excessive burden to many firms.Participants are encouraged to bring a cleaning problem to the course for inclusion in the “ParticipantProblem Clinic” on the second day.

Course Director:Steven A. Weitzel, Technical Director, Critical Process Cleaning, Inc.

Tuition:Early Registration (SAVE $200): U.S. $1740 ($1660 with Group Rate*) (Must register and pay by November 21, 2007)







Documentation Management and Control ID: 1866 Offering #: 0802-502

February 25-26, 2008 • New Brunswick, NJWho Should Attend: This basic introductory course is designed for individuals responsible for documenta-tion writing and management in the pharmaceutical and related industries. The course will benefit individualsin a variety of functions such as:

• Quality Assurance • Regulatory • Quality Control • Production• R&D • Product Development • Toxicology • Vendors/Suppliers• Clinical Research • CRO’s

Course Summary: FDA regulations such as Good Manufacturing Practice (GMP) for drugs and medicaldevices, Good Laboratory Practice (GLP), Good Clinical Practice (GCP), as well as quality system stan-dards like ISO 9000, require that documentation, such as standard operating procedures, plans and varioustypes of records, be in place. These regulations, however, do not provide any guidelines to the industry onhow to set up and manage documentation systems. It is, therefore, left to companies to design and set uptheir own internal documentation systems.This course provides hands-on methodology and techniques on how to identify what systems require docu-mentary coverage; how to flowchart operations to identify what type of documentation is required; and howto set up, implement and manage the maintenance of such documentation systems to ensure continuouscompliance. Types of documentation addressed include: quality manuals, policy manuals, standard operat-ing procedures, work instructions, forms, records, logs, protocols, etc. The course also covers areas relat-ed to computer validation documentation, such as validation protocols and 21 CFR Part 11—ElectronicRecords and Signatures. Emphasis is placed on controls that need to be in place to ensure proper manipu-lation of documentary systems.

Course Director:Renée B. Galkin, Quality Management Consultant



ACCREDITATIONS/CERTIFICATIONSThe Center for Professional Advancement(CfPA) is accredited by the AccreditationCouncil for Pharmacy Education as a providerof continuing pharmacy education. ContinuingEducation Units (CEU) will be awarded only

upon successful completion of the course, i.e., attendance atessentially all the formal sessions and submission of a courseevaluation. The CEU rate is 0.1 CEU per contact hour; certifi-cate will be mailed within six weeks. You will have an opportu-nity to evaluate your successful completion of these courseobjectives through a Learning Assessment. This offering isProgram# 716-000-07-119-L04

The American Association of Family andConsumer Sciences has approved thiscourse for 12 Professional DevelopmentUnits.

This course (#07-1810)has been approved for 2.0Certification Maintenance

Points by The American Board of Industrial Hygiene(ABIH) for recertification.

CfPA is a program sponsor approved by the PennsylvaniaBoard of Accountancy #PX-002022-L. This course hasbeen approved for these purposes.


March 10-12, 2008 • Isle Verde, Puerto RicoWho Should Attend: This practical program will be of benefit to all medical device personnel involved withtheir company’s Complaint Systems including:• Implementation • Regulatory Compliance • Management• Product Performance • Auditing • Training

Monitoring

Course Summary: Complaint handling systems have come under intense scrutiny by the FDA in recentyears. This course will examine the current industry FDA environment and will give you tools for survival. It will provide a step-by-step guide to the setting-up, operation, management and auditing of a complaint system for today’s medical device industry environment.

There will be case studies in which various examples of complaint systems will be presented. Pragmatic, simple, statistical trend methods will be reviewed and attendees will utilize what they learn in a series ofworkshops.

Course Director:Michael Barile, Managing Partner, Barile & Associates, Consulting for the Medical Device,Pharmaceutical, Human Tissue, and Biotechnology Industries



Complaint Procedures for Medical Devices ID: 1834 Offering #: 0803-206


Education Units (CEU) will be awarded only upon successfulcompletion of the course, i.e., attendance at essentially allthe formal sessions and submission of a course evaluation.The CEU rate is 0.1 CEU per contact hour; certificate will be mailed within six weeks. You will have an opportunity to evaluate your successful completion of these courseobjectives through a Learning Assessment. This offering is Program# 716-000-07-125-L04




18 Recertification Credits

Design Control and Product Validation ID: 1900 Offering #: 0801-402

January 24-25, 2008 • New Brunswick, NJWho Should Attend: This course is intended for personnel who are responsible for medical devicedesign and development such as

• Engineers • Senior technicians • Scientists• Project leaders • Department heads • Technical managers

Quality assurance, compliance and regulatory personnel will also benefit because of their responsibilityfor implementation, validation and evaluation of design controls as part of the overall quality system.Sales and marketing personnel will learn their vital roles in providing input to the design process andrequirements for design changes.

Course Summary: The course describes how to establish and implement a system for design con-trols for various classes of medical devices for both the U.S and Europe. It also provides guidance toassist manufacturers in knowing when controls are required. The underlying concepts will be explainedin practical terms and exercises will be used to promote understanding.

Emphasis will be on understanding the requirements and providing tools to assist in management ofthe design control process. The course will discuss each phase of the design process and explain theterms: design input, design output, design review, verification, validation, and design history file.Particular emphasis will be given to understanding the difference between design verification vs.design validation, and describing activities relative to validating a product design. Also discussed willbe FDA's inspection strategy and how to manage a successful audit for design controls.

Course Co-Directors:Jan Miller & Michele Vovolka Quality Systems Consultants, Vantage Consulting International, Ltd.



ACCREDITATIONS/CERTIFICATIONSThe Center for Professional Advancement(CfPA) is accredited by the AccreditationCouncil for Pharmacy Education as a providerof continuing pharmacy education. ContinuingEducation Units (CEU) will be awarded only

upon successful completion of the course, i.e., attendance atessentially all the formal sessions and submission of a courseevaluation. The CEU rate is 0.1 CEU per contact hour; certifi-cate will be mailed within six weeks. You will have an opportu-nity to evaluate your successful completion of these courseobjectives through a Learning Assessment. This offering isProgram# 716-000-06-005-L04



GMP for Dietary Supplements ID: 2094 Offering #: 0803-211

March 13-14, 2008 • Burlingame, CAWho Should Attend: This course will benefit consultants and others involved in the dietary supplementindustry including, but not limited to, those involved in:

• Supplying and distribution of • Regulatory Affairs • Quality Control/Assurancedietary supplements • Manufacturing • Laboratory Operations

• Auditing of in-house and • Labeling contract laboratories • Scientists

Course Summary: This two-day course will cover regulatory and legal aspects of GMP’s for dietary supplements. It will provide a comprehensive introduction and a “how to” program for implementation.Participants will understand issues involved in manufacturing and testing of dietary supplements. They will become familiar with FDA expectations when performing audits of dietary supplement companies. A rational approach to setting up manufacturing and improving a GMP compliant operation will be presented.

FDA Final Rule; No Longer Voluntary

Course Director:Joy Joseph, Consultant to the Pharmaceutical, Dietary Supplement and Cosmetic Industries






Emulsion-Suspension Technology ID: 274 Offering #: 0801-503January 28-30, 2008 • New Brunswick, NJWho Should Attend: This program will benefit personnel in the pharmaceutical, cosmetic, personal care,household products and food industries including: • Scientists • Quality control • Technologists • Regulatory affairs specialists• Engineers • Pilot plant • Product planning • Production research• Development personnel

Course Summary: This course emphasizes the application of emulsion and suspension principles to thesolution of practical, technological problems in the preparation and evaluation of pharmaceutical, cosmeticand related personal care products. Throughout the course, the interrelationship of the many specialtyareas involved in emulsion and suspension products will be stressed. Newer technologies such asmicroemulsions and liposomes will be discussed. A blend of scientific principles and practical technologywill be presented with special attention to the conceptual model of the oil-water interface as the basis foremulsion design. Techniques for studying the solid-liquid interface will be presented and applied to physico-chemical problems which arise in the development of suspensions. Processing problems, with particularemphasis on scale-up, will be discussed.

Course Co-Directors:Dr. Stanley L. Hem, Professor of Physical Pharmacy, Purdue UniversityDr. Norman D. Weiner, Professor of Pharmaceutics, University of Michigan

Tuition:Early Registration (SAVE $200): U.S. $1740 ($1660 with Group Rate*)(Must register and pay by December 3, 2007)


Good Laboratory Practices (GLP) ID: 545 Offering #: 0802-302

February 11-13, 2008 • Boca Raton, FLWho Should Attend: This course is intended for all management within industry, government, academiaand/or contract biological testing facilities especially: • Scientists • Regulatory/Compliance Personnel • Those newly assigned GLP responsibilities• Quality Assurance Staff • More experienced personnel needing to update their knowledge

Course Summary: The main intent of this course is to review the requirements imposed by GoodLaboratory Practice (GLP) regulations for facilities engaged in, toxicology and product safety testing, primarily in animals and biological test systems. The responsibilities and functions of management, theStudy Director, Principal Investigator and the Quality Assurance Unit (QAU) will be covered. Various procedures for meeting the requirements of the regulations will be presented.The lectures will be supplemented by a question and answer session conducted by the Faculty and byworkshops involving problem-solving exercises. The course will concentrate on OECD and FDA Good Laboratory Practice and their application. This willinclude recent developments regarding multi-site studies and their practical interpretation. Additionallythere will be sessions relating to computer validation, particularly as required by FDA in their 21 CFR Part11 documents.Emphasis will be placed on practical implementation of GLP and discussion including consideration of problems that the participants bring to the course. Practical hints and recommendations for steps in theimplementation of GLP will be included.

Course Director:Mr. David Long, Consultant, Long & Associates International Consulting Ltd.

Tuition:Early Registration (SAVE $200): U.S. $1740 ($1660 with Group Rate*)(Must register and pay by December 17, 2007)


ACCREDITATIONS/CERTIFICATIONSThe Center for Professional Advancement (CfPA)is accredited by the Accreditation Council forPharmacy Education as a provider of continuingpharmacy education. Continuing Education Units(CEU) will be awarded only upon successful

completion of the course, i.e., attendance at essentially all the formal sessions and submission of a course evaluation. The CEU rate is 0.1 CEU per contact hour; statement of credit will be mailed within six weeks. You will have an opportunityto evaluate your successful completion of these course objectivesthrough a Learning Assessment. This offering is Program# 716-000-07-134-L04

This course (#07-1804)has been approved for 3.0 Certification

Maintenance Points by The American Board of IndustrialHygiene (ABIH) for recertification.

This course meets Board of Certified Safety Professionals(BCSP) criteria for points toward the Continuance ofCertification requirements.


6 For course information, go to www.cfpa.com For course information, go to www.cfpa.com 7



The Center for ProfessionalAdvancement (CfPA) offersmany courses which have a

chemical component. Such courses may earn up to 20Certification Units toward certification by The NationalCertification commission in Chemistry and ChemicalEngineering, sponsored by The American Institute ofChemists.


Drug Product Stability and Shelf Life ID: 599 Offering #: 0803-109

March 5-7, 2008 • New Brunswick, NJWho Should Attend: This course contains in-depth coverage of the science and practice of drug stabilityand shelf-life, and is designed to benefit the following personnel:

• QC/QA Managers/Supervisors • Research & Product Development Scientists and Managers• Product Stability Managers • Regulatory Personnel• Manufacturing Personnel • Pharmaceutical Consultants

Course Summary: This course focuses on the science and principles concerning stability of pharmaceuti-cal, biotechnology and cosmetic products. Kinetic approaches to chemical stability will be covered and the advantages and limitations of accelerated stability testing will be discussed. Degradation by chemical,physical and microbiological factors will be covered. Data analysis and practical aspects of stability such as the role of packaging in stability will be included. Considerable attention will be given to analytical methodology, data analysis and data management. Current FDA Stability guidelines and ICH Guidelines on stability will be discussed. The course includes a workshop for hands-on experience of data and statistical analysis.

Course Director:Dr. Pardeep K. Gupta, Associate Professor of Pharmaceutics,Philadelphia College of Pharmacy University of The Sciences in Philadelphia (USP)

Tuition:Early Registration (SAVE $200): U.S. $1740 ($1660 with Group Rate*)(Must register and pay by January 9, 2008)




The Center for ProfessionalAdvancement (CfPA) offersmany courses which have

a chemical component. Such courses may earn up to 20 Certification Units toward certification by The NationalCertification Commission in Chemistry and ChemicalEngineering, sponsored by The American Institute ofChemists.



INDs, NDAs vs CTDs Global Regulations ID: 448 Offering #: 0803-201

March 10-12, 2008 • Burlingame, CAWho Should Attend: This course is specifically designed for personnel in the pharmaceutical andbiotechnology industries who need a detailed understanding of what comprises an IND, NDA, BLA,ANDA, SNDA, and CTD. This includes but is not limited to those involved in:

• Pre-Clinical Research • CMC Components • Regulatory Affairs • Management• Clinical Research • Quality Assurance • Product DevelopmentParticipants should have a basic understanding of new product development and/or regulatory affairs inorder to best comprehend the lectures presented in this course.

Course Summary: The content of this course is designed to present the intricate parts of INDs, NDAs,BLAs, ANDAs, SNDAs and CTDs. These regulatory submissions for drug and biologic products will bebased on the requirements of the US Code of Federal Regulations, the ICH Guidelines for global submis-sions and the EU Directives. Specifics of the IND, NDA, BLA, ANDA, SNDA and CTD will be detailedfor safety, quality, and efficacy. Non and pre-clinical data, clinical data and CMC data to achieve productapprovals globally will be enumerated for expediting new product approvals. Other subject areas include:

• FDAs internal structure, policies, and procedures • GCP, GLP and GMP regulation requirements for INDs, NDAs, BLAs, ANDAs, SNDAs, CTDs and

Drug Master Files• The FDA review process for new product approvals, including FDA/Industry Meetings and Liaison• Acceptance of foreign data for new product approvals, EU Directives on global submissions.

Course Director:Dr. Richard A. Guarino, President, Oxford Pharmaceutical Resources, Inc.







ICH Q10: Phamaceutical Quality System ID: 2131 Offering #: 0803-402

March 27-28, 2008 • New Brunswick, NJWho Should Attend: This course has been designed to benefit those in the Pharmaceutical industry withresponsibilities related to the design, operation or management of the overall Quality System or any individ-ual quality system used by the industry. The course is particularly suitable for personnel working in:• Site & Corporate Management • Production • Pre-Market Departments• Regulatory Affairs • Quality Units (including QA, QC & Quality Audit)The course is applicable to personnel in API, commodity and outsource suppliers to the industry in additionto those in primary manufacturers of drug products.

Course Summary: The draft of ICH Q10 is the latest document that aims to define the requirements for a quality system for pharmaceutical operations. It discusses how the function of the system should evolveduring pre-market operations, what its function is when a drug is marketed and how opportunities for prod-uct improvement should be identified and implemented throughout the product life cycle. The main elementdiscussed in Q10 is what management, especially senior management, should be responsible for in assur-ing an effective Quality System. Other important elements receiving an emphasis in Q10 are the QualitySystem components such as change control, deviation control, CAPA, root cause determination,input/process/output monitoring, product reviews and documentation.This course analyzes the content of Q10 and compares it with previous standards including the FDAGuidance on Quality Systems and ISO 9000. It analyzes its relationship with Q8 (Product Development) andQ9 (Risk Management) and the FDA Guidance on their Six-Systems Inspection Program and discusses thequality systems to which Q10 refers with particular reference as to how such systems can be effectivelymanaged & integrated in accordance with Q10.

Course Director:Alan J. Smith, Ph.D, Pharmaceutical Quality & Technology ConsultantWith Presentations by: John G. (Jerry) Lanese, Ph.D, President, The Lanese Group, Inc.




Education Units (CEU) will be awarded only upon successfulcompletion of the course, i.e., attendance at essentially all theformal sessions and submission of a course evaluation. TheCEU rate is 0.1 CEU per contact hour; statement of credit will be mailed within six weeks. You will have an opportunity to evaluate your successful completion of these course objec-tives through a Learning Assessment. This offering isProgram# 716-000-07-401-L04


Granulation, Tabletting & Capsule Technology ID: 541 Offering #: 0803-302

March 17-20, 2008 • Boca Raton, FLWho Should Attend: This broadly based course is intended for all scientists and technologists con-cerned with the development and processing of tablets, capsules and similar products, and with relateddrug regulatory affairs.The material will be presented in such a way as to be of value to a varying level of expertise. This coursewill especially benefit those in:

• Quality Assurance • R&D • Marketing • Regulatory Affairs

• Validation • Manufacturing/Production • Purchasing • Engineering Support

Course Summary: The main aim of this course is to review the science relating to tabletted and encap-sulated pharmaceutical products. The course begins with a consideration of raw material testing and thebasic aspects of powder and granulation technology, progresses through formulation of solid dosageforms to manufacturing processes and equipment including scale-up and technology transfer. The pro-gram concludes with key aspects of the evaluation of finished products and the regulatory constraintsthat must be considered at each stage. Formal sessions of the course are supplemented with informaldiscussion periods between lecturers and course participants and problem-solving sessions are held onboth an open and private basis.

Course Director:Dr. Cecil W. Propst, Director of R&D, SPI Pharma Group, Grand Haven

Tuition:Early Registration (SAVE $200): U.S. $2155 ($2055 with Group Rate*)(Must register and pay by January 21, 2008)







In Vitro Testing Methodologies for Safety Assessment of Cosmetic Ingredients ID: 2161 Offering #: 0803-306

March 17-19, 2008 • New Brunswick, NJWho Should Attend: Professionals in the cosmetic and personal care or related industries that work andspecialize in the following disciplines, as well as groups or companies that provide services in theseareas:

• Research and Development • Product Development• Regulatory Affairs • Formulations Development• Safety Assessment

Course Summary: This comprehensive course attempts to provide the spectrum of the reasons, rationale, tools and approaches to address safety assessment of cosmetic ingredients.

In this current environment of establishing regulations and environmental issues awareness, an effort isput together to offer guidance to individuals in the industry who are concerned with present approachesand future implications.

With the unique position of the cosmetic and personal care industry of animal testing ban and emergenceof REACH, this course is designed to bring together records on key parties involved, market leads andsources for information.

The core of the course is focused on the understanding of current available methodologies to test forsafety, their scope and limitations.

Course Director:Nava Dayan, Ph.D., Director R&D, Lipo Chemicals







Microencapsulation and Particle Coating ID: 774 Offering #: 0802-301

February 11-13, 2008 • New Brunswick, NJWho Should Attend: The course should be of value to those working in microencapsulation, as well as to those in industry and research laboratories who would profit from a thorough presentation anddiscussion of the many techniques and the characteristics of the microcapsules formed from them. It should be of particular interest to personnel in the following industries:

• Pharmaceutical • Cosmetic • Bioengineering

• Food • Chemical • Agricultural

Course Summary: This program will provide an up-to-date assessment of available encapsulation techniques. Each lecturer will present the basic chemical and physical principles of their processes, as well as a discussion of specific techniques and applications. The aim of the program is to provide an understanding of the unique advantages and difficulties of each major microencapsulation technique.Emphasis will be placed on proven techniques, results and actual applications in various industries. The instructors, all of whom are recognized experts in their areas, will present the latest available information regarding the processes in which they specialize. The lectures are structured to encourageopen discussions between lecturers and participants.

Course Director:Dr. James D. Oxley, Senior Research Scientist, Department of Microencapsulation,Nanomaterials, and Process Engineering, Southwest Research Institute






This course (#07-1805)has been approved for 3.0 Certification

Maintenance Points by The American Board of IndustrialHygiene (ABIH) for recertification


March 12-14, 2008 • New Brunswick, NJWho Should Attend: The course is designed for professionals in the medical device, biotechnology andpharmaceutical industries including:• Those needing a basic knowledge of microbiology as it affects their function• Microbiology personnel who wish to get updated on new, more reliable rapid testing, monitoring and

identification methods• Audit personnel needing more background in the microbiological aspects to be considered when auditing• Personnel with little background in microbiology, such as manufacturing,validation,and facilities staff that

need to gain a better understanding of how to better deal with microbiological issues

Course Summary: This course will present information on microbiological control in manufacturing,laboratory auditing and sterilization. The course will also cover ISO, EP, BP, USP, AAMI and U.S. FDAdocuments and guidelines. Validation of sterilization processing will be discussed and case studies willbe presented. Environmental monitoring programs will be discussed in depth. Design and testing ofproduct packages for sterility assurance will be covered via case studies. All aspects of microbiologi-cal control will be covered. Microbiological testing schemes will be presented and the key aspects ofGLP/cGMP will be reviewed. You are invited to bring transparencies of monitoring programs, proce-dures, flowcharts, etc., for discussions during the case studies on the third day.

Course Director:William Marshall, President, William G. Marshall and Associates








Microbiological Control and Validation ID: 902 Offering #: 0803-202IQ/OQ/PQ ID: 1808 Offering #: 0803-103

March 5–6, 2008 • Boca Raton, FLWho Should Attend: This introductory course is designed for individuals who need a basic, but thor-ough, understanding of the Validation Process for equipment and processes used in the manufacturing ofpharmaceutical sterile and oral solid finished dosage forms, and bulk active ingredients through the use of IQ/OQ/PQ Protocols. The course will benefit individuals in:

• Engineering • Technical Services/Validation • Production• Quality Control/Assurance • R&D • Regulatory Affairs• University and allied health care professionals

Course Summary: The installation/operational/performance qualification of equipment, systems, facili-ties, and processes for pharmaceutical sterile, oral solid dosage, finished and bulk manufacturing opera-tions are an essential part of the validation process. Equipment must be installed, operated, and main-tained within design specifications, while processes must be shown to be reliable, all of which to assurethe consistent quality and integrity of the product. This course provides a basic and thorough understand-ing to preparing, executing, reviewing, and approving protocols. A Risk Based approach to impact andcritical component assessment is also provided along with an overview of the current on-going activities toprovide International Consensus Standards being considered by the Industry and Regulatory authorities todefine future Qualification requirements. Protocol examples/workshops will be utilized to enhance thelearning, however this course will not provide a library of completed protocols.

Course Director:Steven J. Wisniewski, Senior Associate and Director of Compliance, Integrated Project Services (IPS)




Education Units (CEU) will be awarded only upon successfulcompletion of the course, i.e., attendance at essentially allthe formal sessions and submission of a course evaluation.The CEU rate is 0.1 CEU per contact hour; statement ofcredit will be mailed within six weeks. You will have anopportunity to evaluate your successful completion of these course objectives through a Learning Assessment.This offering is Program# 716-000-07-137-L04

This course (#07-1808)has been approved for 2.0Certification Maintenance

Points by The American Board of Industrial Hygiene(ABIH) for recertification.



March 31–April 2, 2008 • Isle Verde, Puerto RicoWho Should Attend: Participants who work in the medical device industry and who currently are or wishto sell their product in the US, Europe and other parts of the world will profit by attending this course. This includes professionals responsible for understanding and interpreting global regulations within theircompanies, in areas such as:• Regulatory • QA • R&D • Manufacturing

Course Summary: This course provides a detailed description of the current European and US regula-tions for medical devices. With the continued growth in the development and acceptance of global standards, all device companies must stay up to date on the various regulations to ensure marketability of their products globally. With 25 European countries now using the ISO 13485 standard, it is critical tocompanies to understand how the similarities and differences in these standards can be implemented into their own quality system to enhance their marketability. The primary focus of this course is on thedevelopment of one quality system which complies with the ISO 13485:2003 standard, ISO 9001:2000standard and the FDA Quality System Regulations. Participant interaction, problem solving and open discussion will be strongly encouraged.

Course Director:Bea Salis, Consultant, QualASyst International

Tuition:Early Registration (SAVE $200): U.S. $1840 ($1760 with Group Rate*) (Must register and pay by February 4, 2008)





ISO 13485, ISO 9001 and QSR Regulations for Medical Device Companies ID: 2092 Offering #: 0803-501

18 Recertification Credits


March, 10-11, 2008 • New Brunswick, NJWho Should Attend:

This course is intended for professionals involved in the pharmaceutical and related industries, including,but not limited to:

• Quality Assurance • Quality Control• Production • Regulatory• Engineering • Research and Development, and software • Process Design and Development

Course Summary: Validation of manufacturing processes in the cGMP environment is recognized by themedical manufacturing industries and by the regulatory agencies in the U.S., E.U. and Japan. This coursewill give the attendee an overview and understanding of the validation process, how to organize it and carryout process validations, key areas to look for during an audit, and assist managers in overall planning.

Various approaches to validation will be discussed with actual examples of successes and failures of industry validation experiences.

Participants are invited to bring examples of their own validation issues to be discussed during the casestudies session.

Course Director:William G. Marshall, President, William G. Marshall & Associates




Education Units (CEU) will be awarded only upon successfulcompletion of the course, i.e., attendance at essentially allthe formal sessions and submission of a course evaluation.The CEU rate is 0.1 CEU per contact hour; statement ofcredit will be mailed within six weeks. You will have anopportunity to evaluate your successful completion of thesecourse objectives through a Learning Assessment.This offering is Program# 716-000-07-149-L04


Process Validation for the Pharmaceutical and Medical Device Industries ID: 736 Offering #: 0803-210

Non-Clinical Drug Safety Evaluation & Drug Development ID: 1153 Offering #: 0802-505

February 27-29, 2008 • New Brunswick, NJWho Should Attend: This course is designed for a broad range of pre-clinical, clinical, management,investment, and regulatory personnel in both established and emerging pharmaceutical companies. It will be of special value to:• Scientists who wish to gain an understanding of pharmaceutical toxicity studies• Managerial personnel • Project management staff• Investors • Regulatory Scientist involved in preclinical development

Course Summary: This course provides a comprehensive explanation of the non-clinical develop-ment of drugs and biologics, emphasizing the principles of pharmaceutical toxicology and theassessment of product safety. In addition to the different types of toxicity studies in modern phar-maceutical development, it also describes the relationship between pharmacology, clinical trialdesign, regulatory strategy and project management.Emphasis will be placed on how toxicity studies are integrated into the multidisciplinary developmentplans of new drugs and biologics, and how they affect development decisions. Regulatory affairswill be covered, and descriptions given of the European and the U.S. FDA requirements, the newdrug review process, and common regulatory errors.The goal of this course is to give a working knowledge of pharmaceutical toxicology and drug devel-opment to enable you to develop new drugs faster and more efficiently.

Co-Directed by:Dr. Shayne C. Gad, Principal of Gad Consulting ServicesProfessor Friedlieb Pfannkuch, M.D., Pharma Research–Global Non-Clinical Safety





This course (#07-1807) has beenapproved for 3.0

Certification Maintenance Points by The American Boardof Industrial Hygiene (ABIH) for recertification

This course meets Board of Certified Safety Professionals(BCSP) criteria for points toward the Continuance ofCertification requirements.


February 6-8, 2008 • Houston, TXWho Should Attend: This comprehensive course is intended for professionals in the pharmaceutical,chemical, petroleum, and instrumentation industries, including:• Process and analytical chemists• Process control specialists• Chemical engineers• Manufacturing and quality improvement managers• Sales or service engineers• Instrumentation engineers

Course Summary: Online chemical process analysis is a rapidly evolving technology offering large poten-tial savings in energy costs, reduction of offgrade production, efficient facilities employment, improved safety, and better quality. In addition, an in-situ analyzer in a pilot facility can help to tune processes andspeed scaleup. On the other hand, the wrong analyzer or a problematic installation can cost hundreds ofthousands of dollars with no gain. It is important that informed decisions be made on the purchase andinstallation of these instruments. This three-day course will provide an overview of some of the mostimportant of the currently available technologies, how they compare, where they might be employed,example applications, and what is needed to achieve a successful installation. Calibration issues, spectralinterpretations, and comparison with laboratory values, will be covered and examples given. Many othertypes of analyzers, such as pH, moisture, physical property, inferential, acoustic, density and others will also be reviewed, but in less detail than chemical composition analyzers.

A Team Presentation by:Christian Hassell, Science and Technology Group Leader, AMTIJames F. Tatera, Sr. Process Analysis Consultant, Tatera & Associates Lois G. Weyer, Analytical Chemist with Alliant Techsystems (ATK) and Consultant with Tres-Ark, Inc.




The Center for ProfessionalAdvancement offers many

courses which have a chemical component. Such coursesmay earn up to 20 Certification Units toward certification byThe National Certification Commission in Chemistry andChemical Engineering, sponsored by The AmericanInstitute of Chemists.


PAT Online Process Analysis ID: 2030 Offering #: 0802-201


February 20-22, 2008 • New Brunswick, NJWho Should Attend: Engineers and scientists who are involved with process development, processtranslation, scaleup and pilot plant studies will benefit from this course. This includes those in:

• Pilot plant operations• Specialty chemical production• Food processing• Chemical reactor design• Waste processing

Course Summary: This course will provide concepts, methods and advice on how to scaleup or trans-late a process or model to larger sizes. Emphasis throughout the course will be on proper designs, modeling and processing. The importance of the process geometry will be emphasized.

The course will cover the different scaleup methods and how to establish viable process objectives. A general scaleup method is presented and a number of examples are worked as illustrations. Scaleup traps and pitfalls are reviewed as well as ways to avoid these. The importance of process objectives will be emphasized. Basic concepts of importance are reviewed usingdifferent areas as examples. Power analysis will be presented as a useful tool in scaleup. Examples will show how to use the power analysis in applications and to establish the controlling mechanisms. Detailed suggestions for pilot studies will be given. Scaleup in the mixing and contacting area is reviewed. Equipment, operating conditions, optimum designs and processing conditions will be discussed. Methods to perform process translation in mixing will be developed and examined as to their practicality. Correlations and data use will be reviewed for process accuracy and use in pilot studies. Pitfalls and the use of analogies in solving processing problems will be discussed.

Course Director:Dr. Gary B. Tatterson, Professor, Chemical Engineering, North Carolina A&T State University

Tuition:Early Registration (SAVE $200): U.S. $1825 ($1745 with Group Group Rate*) (Must register and pay by December 26, 2007)

Regular Registration: U.S. $2025 ($1945 withGroup Rate*)

Pilot Plant and Scale-Up Studies Process Development and Scale-Up Methods ID: 1882 Offering #: 0802-401

• Pharmaceutical production• Process and project design• Composite material manufacturing• Biotechnology and fermentation




February 25-27, 2008 • Burlingame, CAWho Should Attend: This overview course is intended for those having specific responsibilities in theareas of sterile drug product science and technology. It will be of particular value to those in:

• Research• Production• Development• Quality Assurance and Control

Those who wish to broaden their appreciation of these technologies and review the latest developments,as well as managers who have responsibility for a broader base of activities will find the course of interest.

Course Summary: This comprehensive course provides an appreciation and general understanding of the overall contemporary state of science and technology associated with the design, development andmanufacturing of sterile drug dosage forms. Emphasis will be oriented toward formulation developmentand product manufacture of quality sterile dosage forms that meet or exceed expected good manufactur-ing practice requirements.

Course Director:Dr. Michael J. Akers, Senior Director of Pharmaceutical R&D , Baxter BioPharma Solutions






Sterile Products: Formulation, Manufacture and Quality Assurance ID: 435 Offering #: 0802-510

February 11-12, 2008 • New Brunswick, NJWho Should Attend: This course is specifically designed for personnel in the pharmaceutical, biotechnology and related industries who use contract research organizations (CROs) for the discovery and development of new drugs, devices, and biologics.

This includes, but is not limited to:- Scientists- Managers- Project Team Leaders

Participants should have some experience in the processes involved in new product submissions.

Course Summary: The content of this course will assist pharmaceutical and biotechnology researchersand managers and their counterparts in the CRO industry in understanding the requirements for a wellde-signed and successful outsourcing program that is completed on time, within budget, and in compliancewith FDA regulations and ICH guidelines. The types of CROs and the various outsourcing requirements will be presented to assist in designing the sponsor-generated outsourcing program. Proposal solicitationand evaluation, site visits, contract negotiations, and other items necessary for identifying and selecting aCRO will be discussed. Research study planning, monitoring, problem assessment and correction, andother areas involved in successfully managing a CRO will be presented. FDA views and legal obligations of CROs and sponsors, including generation and review of study reports submitted in INDs and NDAs, will be detailed. Emphasis will be given to the overall management of CROs; how to resolve issues of monitoring, timeline lags, and effective communication.

Course Director:Dr. Richard A. Guarino, President, Oxford Pharmaceutical Resourses, Inc.






Selecting and Managing CROs ID: 2032 Offering #: 0802-303


Skin Product Development ID: 1050 Offering #: 0803-104

March 5-7, 2008 • Burlingame, CAWho Should Attend: The course is designed for individuals who are engaged in the personal care, cosmetic and pharmaceutical industries. It is intended for individuals who work both in the development of raw materials, delivery systems and finished formulations, including:

• Research and Development • Technical Sales • Formulations Development • Marketing

Course Summary: The design of topically applied formulation combines scientific knowledge in physics, chemistry, engineering and biochemistry and requires imagination and artistic skills.

Throughout the design, one must become familiar with the fundamentals of skin structure, itspharmacology and possible delivery approaches. The understanding of formulation’s physical properties,ways of measuring these properties are additional essential aspects to learn.

Becoming familiar with both, one can extrapolate the possible interactions between a topically appliedformulation and the skin as a viable organ. This can allow for optimization of development.

Over the past decade, both the pharmaceutical and cosmetic industries have gone through majorchanges that are mainly driven by consumer demand, aggressive market claims, regulatory issues and scientific breakthrough discoveries.

This course will provide participants with understanding the diversity of the above and will channel andfocus their development approaches. It will also provide knowledge in related terminology to createsales tools and marketing claims.

Course Director:Nava Dayan, Ph.D., Director, Lipo Chemicals





The Center for ProfessionalAdvancement offers manycourses which have a

chemical component. Such courses may earn up to 20Certification Units toward certification by The NationalCertification Commission in Chemistry and ChemicalEngineering, sponsored by The American Institute ofChemists.


System Validation, GAMP Harmonization and P.A.T. ID: 913 Offering #: 0803-401

March 26-28, 2008 • New Brunswick, NJWho Should Attend: This course is designed for both users and developers of FDA regulated systems,especially personnel involved in:

• Conducting Clinical Studies • Laboratory Analysis • Quality Assurance• Product Development • Regulatory Submissions • Information SystemsThose developing, acquiring, using, modifying, auditing, designing, and marketing systems and devices thatsupport FDA regulated studies, submissions, projects and products will also benefit.

Course Summary: This course is designed to provide the basics of computer system validation. Utilizinglectures, discussions, hands on exercises, the class will address the rules, tools and techniques neededto develop, manage, and conduct a validation process and project. The program focuses on the best validation practices utilizing, Risk assessment, PAT, GAMP 4 and more. Included in this comprehensive course is:

• Validation testing, The Validation Plan, SOPs• System Life Cycle, Hazard Assessment• Validation Requirements of Predicate Rules

including: cGMPs, GLPs, QSRs and GCPs• Disaster Planning and Business continuation,

IQ, OQ, PQ• System Security, Training Requirements,

and Traceability

The course workbook is designed to support you in class and to be a detailed and completevalidation reference guide.

Course Director:Philip E. Sax, Principal Consultant and President, FDA Compliance Solutions


Regular Registration: U.S. $1940 ($1860 with Group Rate)




• ERES 21 CFR Part11, Electronic Submissions• Source Code Vendor Review• COTs and Shrink Wrapped Systems• GAMP 4 and PAT• Sarbanes Oxley• FDA Guidance for Industry-Computerized

Systems Used in Clinical Trials


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16 For course information, go to www.cfpa.com 17For course information, go to www.cfpa.comID: 2138 - Offering: 0710-803 - BID: C7-249

Accreditations/Certifications

The Center for Professional Advancementhas been reviewed and approved as anAuthorized Provider (#640) of continuingeducation and training programs by theInternational Association for Continuing

Education and Training (IACET). Continuing Education Units (CEU)will be awarded for participation in the courses noted in this catalog at a rate of 0.1 CEU per contact hour. CEU will be awarded only uponsuccessful completion of the course, i.e., attendance at essentially all the formal sessions and submission of a course evaluation.

ASQ Certification: ASQ Certified Quality Engineers,Reliability Engineers and Quality Auditors may earnrecertification credits for attending certain programs withinthis catalog providing it is covered under one area of thebody of knowledge in which they are seeking recertificationor is job enhancement.

The Center for Professional Advancement(CfPA) offers many courses which have achemical component. Such courses may

earn up to 20 Certification Units toward certification by The NationalCertification commission in Chemistry and Chemical Engineering,sponsored by The American Institute of Chemists.

The American Association of Family and ConsumerSciences has approved the designated courses forProfessional Development Units.

This course meets Board of Certified Safety Professionals (BCSP)criteria for points toward the Continuance of Certification requirements.

Locations

Certain courses in this catalog have been approved forrecertification credits by the AACE International CertificationBoard toward meeting the continuing education requirementsfor recertification as a Certified Cost Engineer, Certified CostConsultant, Planning and Scheduling Professional and EarnedValue Professional.

The Center for Professional Advancement (CfPA) isaccredited by the Accreditation Council for PharmacyEducation as a provider of continuing pharmacy education.Continuing Education Units (CEU) will be awarded only upon

successful completion of the course, i.e., attendance at essentially all theformal sessions and submission of a course evaluation. The CEU rate is 0.1CEU per contact hour; statement of credit will be mailed within six weeks.You will have an opportunity to evaluate your successful completion of thesecourse objectives through a Learning Assessment. (See specific course fordetails)

SME Certified Manufacturing Engineers (CMfgE) and Technologists (CMfgT) may earn recertificationcredits. (See specific course for details) Certificationis valuable to everyone in industry. It is a recognized

method of maintaining knowledge and skills in your field. For completedetails on SME Certification, contact Diane Wrobel, Coordinator, SME,Manufacturing Engineering Certification Institute, One SME Drive,Dearborn, MI 48121, 313.271.1500, ext. 516.

ABIH Certification:Certain courses have been approved

for Certification Maintenance Points by The American Board of IndustrialHygiene (ABIH) for recertification. (See specific course for details)

A limited block of rooms in the hotel will be held for our registrants until four weeks before the course. Participants must, however, make their own reservations; the cost of hotel accommodation is not included in the course fee.

To receive CfPA's rate and room block, be sure to mention that you will be attending one of our courses.

CfPA holds 13 Accreditations. The following are available for the selected courses in this catalog. For more informationon all of our Accreditations/Certifications visit our website at www.cfpa.com.

CfPA courses on pages 1-16 are held in the following hotels. Please refer to individual course on our website for appropriate location.

Terms and ConditionsDiscounts/Rates: Early registration discount requires payment at time of registration and before expiration or regular tuition will apply.

*Group Rate is for two or more enrollments registering at the same time, from the same company, for the same course. Multiple discounts not applicable.

Cancellations/Substitutions: All cancellations are subject to a $150.00 processing fee. Applicants may cancel up to two weeks prior to the course start date for a refund. If less than two weeks, a credit will be issued that can be used towards a future course up to one year from the date of issuance. No refunds or credit will be issued for those who do not attend the scheduled course and/or cancel less than two working days before the start date. Substitutions are permitted at any time. If for any reason, CfPA decides to cancel this course, we are not responsible for airfare, hotel or other costs incurred by the registrant. Program content, schedule and instructors are subject to change without notice.

Confirmation Letters: Before each course begins, all registrants will receive written confirmation including detailed information regarding course location. If confirmation is not received two weeks prior to the course please contact us.

For our full terms and conditions, visit www.cfpa.com.

General Information

Burlingame, California:DoubleTree Hotel (SF Airport)835 Airport BlvdBurlingame, CA 94010Phone: 650-344-5500

Embassy Suites SF Airport150 Anza Blvd,Burlingame, CA, 94010 Phone: 650-342-4600

Boca Raton, Florida:Hilton Suites7920 Glades RoadBoca Raton, FL 33434Phone: 561- 483-3600

Embassy Suites Boca Raton661 Northwest 53rd St,Boca Raton, FL 33487Phone: 561-994-8200

New Brunswick, New Jersey:Hyatt Regency2 Albany StreetNew Brunswick, NJ 08901Phone: 732-873-1234

Houston, Texas:Courtyard by Marriott Houston West12401 Katy Freeway Houston, Texas 77079Phone: 281-496-9090

Isle Verde, Puerto Rico:Embassy Suites San Juan8000 Tartak Street, Isla VerdeCarolina, Puerto Rico 00979Phone: 787-791-0505

January 23–25, 2008 • New Brunswick, NJWho Should Attend: This course is intended for professionals in the pharmaceutical and allied industrieswho must write or revise documents that are integral to product development and production. It is ideal for those in

• Research & Development• Quality Control• Regulatory/Compliance• Validation

This includes, but is not limited to:• Engineers• Scientists• Chemists• Technicians

This course is also intended for those who wish to gain better writing skills and learn more effective ways to deliver technical information.

Course Summary: This practical course will teach you the basic steps in preparing those written documents most frequently required in the pharmaceutical and relatedindustries. Through lectures, discussions, and workshops, you will learn to work your way through the writing process to express complex ideas clearly and to organizeyour writing into standard forms such as memos, letters, proposals, and reports. You will also learn strategies for revising, editing, and documenting your work.

Course Director:Patricia Wagner, Professor of English, Victor Valley College





Technical Writing in the Pharmaceutical and Allied Industries ID: 162 Offering #: 0801-401

IntroducingOnline TrainingA new way to experience CfPA’s Accredited Technical Training!

CfPA’s Online Training is a perfect complement to our public and clientsite programs. Experience the ability to supplement your training needs or expand on your knowledge in areas critical to your job function.Available live and on-demand.

Advantages of CfPA’s Online Training:Convenient – Access CfPA Online Training from your office, home

or on the road - anywhere around the world

Interactive – Actively participate with instructor and participants in a virtual classroom through the use of polls, Q&A and other online tools

Topics – All courses taught by leading industry experts, topicareas are similar to our public courses and includebasic concepts to the latest advances

Accredited – Training programs are accredited and/or certified

Easy to Use – All you need is a computer with an internet connection, and a phone line

Cost Effective – Save on travel costs and time out of the office

On-Demand – Previously held courses are available for viewing when it is convenient for you

For more information on our Online Training:Go to www.cfpa.com/onlinetraining or E-mail [email protected]

Customized Training ThroughClient Site ProgramsWhatever your on-site needs may be, we can meet them.

Offered at your location and at your convenience, CfPA will bringany course to your team for customized training, or we can workwith you to develop a program to address the specific issues mostcritical to you.

What are the advantages to a Client Site Course?

• You can have up to thirty-five of your engineers, scientists andtechnical managers participating simultaneously in a course.

• You have the opportunity to tailor the standard program to your company’s specific problems and interests.

• You have one-to-one access with a top teaching teamspecializing in your industry, and comprehensive coursematerial, for an all-inclusive fee.

• You save on costly hotel and travel expenses.

How to arrange a Client Site Course:If your company is interested in a Client Site training program,please contact our Client Site division at 732.238.1600 ext. 4549 or E-mail [email protected].


Documents

Revise - CfPA