ABOUT CfPIELearn from the Leader

In a life sciences industry that has faced nearly $15 billion in fines and compliance-related settlements over the last several years, The Center for Professional Innovation & Education (CfPIE) is a better alternative for maintaining high standards, protecting industry reputations, and enhancing personal growth. Since 2001, we have embraced a singular goal—to provide the highest quality education to life science professionals. Today, as the global leader in quality life sciences training, we offer the largest range of course options for professional development in pharmaceutical, medical device, biotech, and skin/cosmetics disciplines. We are dedicated to enriching that reputation by conveying content relevant to the needs of individuals and organizations facing intense scrutiny in those highly technical disciplines.

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http://www.CfPIE.com

HOW TO REGISTER

COURSE FEE$2150.00 PER PERSON

EARLY BIRD DISCOUNT

The Center for Professional Innovation & Education, Inc. 7 Great Valley Parkway

Suite 295Malvern, Pennsylvania 19355

If you register at least thirty days in advance you will receive a $200 discount on the course.

ADDITIONAL DISCOUNTSContact us at 610-648-7550 or info@cfpie.com for information regarding partnership discounts or how your organization can become a partner with CfPIE

CANCELLATION POLICYAll cancellations must be in writing and are subject to a $350.00 cancellation fee. If cancellations are made more than 30 days prior to the course, a refund less the cancellation fee will be provided. If cancellations are made less than 30 days prior to the course, a voucher good for attendance at an upcoming course will be provided. The voucher, which can be used by the registrant or anyone else within his/her company, will be valued at the registration fee minus the $350.00 cancellation fee.

If a registered attendee does not cancel and fails to attend, neither a refund nor voucher will be issued. All course cancellations must be in writing and emailed sent to info@cfpie.com. Registrants are responsible for contacting the hotel and canceling their room reservations.

CFPIE reserves the right to alter the venue, if necessary.

Substitution Policy - Classroom Courses

Substitutions are accepted at no penalty with written notification from the original registrant in advance of course. All substitution requests must be in writing and emailed to info@cfpie.com.

CfPIE also offers on-site courses for 10 or more attendees. Contact us at info@cfpie.com.

COURSE DESCRIPTION

A large variety of laboratory equipment and analytical instruments, ranging from a simple apparatus to complex computerized systems, are used in the pharmaceutical industry to acquire data that will ensure that drug substances and drug products meet their specifications.

This course will provide an in-depth understanding of how to meet FDA expectations regarding equipment validation and qualification in the analytical laboratory. It also will discuss in detail the necessary time, applicability, and activities associated with analytical instrument qualification through the whole system life cycle – from design, installation, operation and performance qualifications to PM and removal from service along with change control to ensure all changes to validated equipment is documented and performed in a compliant manner.

LABORATORY EQUIPMENT VALIDATION AND QUALIFICATION

INSTRUCTOR: JULIE BARNHILL, PH.D.

COURSE DATES WILL BE OFFERED VIRTUALLY THROUGH LIVE INTERACTIVE

SEMINARS

Mar 8 & 9, 2021 - CSTJun 14 & 15, 2021 - CDT

Oct 4 & 5, 2021 - CDT

Section 1: Introduction

• Components of Data Integrityo Quality Control Check Sampleso System Suitability Testo Analytical Method Validationo Laboratory Equipment

Validation and Qualification

Section 2: Laboratory Equipment Validation and Qualification Process

• User requirements specification (URS)• Qualification activities

o Design Qualification (DQ)o Installation Qualification (IQ)o Operational Qualification (OQ)o Performance Qualification (PQ)

and/or User Acceptance Testing (UAT)

• Strategies for Validation of Computerized Lab Equipment

SECOND DAY

FIRST DAY

INSTRUCTOR CREDENTIALSJulie Barnhill, Ph.D. is a Consultant with Meridian BioGroup LLC and provides QA Compliance expertise to Biopharma/Pharmaceutical companies with products in preclinical, clinical and commercial stages of drug development with the primary objective of helping clients advance their drugs through pipelines and regulatory processes. Her clients include a number of virtual drug companies whose GMP and GLP operations are completely outsourced along with small and medium clinical phase organizations and large commercial drug companies. She has assisted start up organizations develop and implement GMP compliant systems and has supported many companies prepare for FDA inspections. Further, she has helped companies transition from preclinical to first-in-human phase 1 compliance along with phase 2 to phase 3, and clinical phase 3 to commercial launch.

Prior to Meridian, Dr. Barnhill was the QA head for Osiris Therapeutics, head of QA Compliance at Alpharma (now Actavis) and Director of Quality Control and Analytical Development at Chesapeake Biological Laboratories (now Emergent). Her career has been focused on the quality and compliance of mostly parenterals and she also has experience with inhalation and nasal solutions along with orally administered medications.

A deep understanding of drug compliance aligned with her client’s needs underscores Dr. Barnhill’s effective approach in her successful collaborations with a wide variety of clients. Dr. Barnhill is a Board member of the PDA Capital Area chapter and was a member of the Adjunct Graduate Faculty at the Johns Hopkins University Advanced Academic Programs in Biotechnology and Bioscience Regulatory Affairs and is a Lecturer at Mount St. Mary’s University, M.S. Program Biotechnology and Management.

Dr. Barnhill holds a PhD in Bioinorganic Chemistry from the University of Pennsylvania in Philadelphia, Pennsylvania and a B.S. in Chemistry from Trinity College in Hartford, CT.

Section 4: Software Validation

• Instrument Control• Data Acquisition• Processing Software

Section 3: Discussion of Roles and Responsibilities• Users• Quality Unit• Manufacturers and Suppliers• Analysts

Section 5: Change Control

• Changes to qualified instruments• Implementation of changes• Change Control Process

o Assessmento Executiono Documentationo Approval

Section 6: Laboratory Equipment Validation and Qualification Documentation/Creation

• Laboratory equipment validation and qualification - where to begin

• SOP for Laboratory Equipment Validation and Qualification

• Protocols each for IQ, OQ, PQ • Case study: How do you set up an equipment

validation plan for your lab?• Validation Master Plans

Section 7: Recent FDA Inspection Observations related to equipment

• Current trends in compliance issues noted with equipment

LEARNING OBJECTIVESUpon completion of this course you will have a thorough knowledge and understanding of FDA expectations regarding the validation and qualification of laboratory equipment and the know-how necessary to plan and execute effective and compliant lab equipment qualification (EQ) programs. You will also understand why laboratory equipment validation and qualification are significant as a foundational step for overall system sustainability and data integrity, and why EQ is the necessary first step when initiating validation of analytical methods.