44th International Good Manufacturing Practices Conference

PROGRAM

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TABLE OF CONTENTS4 Agenda7 Sponsors7 Program Committee8 Speaker Information14 Georgia Center Map18 Additional Pages for Notes

REGISTRATION LIST AND PRESENTATION SLIDES

1. Go to internationalgmp.com2. Under “Agenda” menu, select

“Presentation Slides”3. Use password “GMP44UGA”

WIFI1. Join your device to the wireless

network named “UGA”2. Open your Internet browser (Safari,

Edge, Firefox, Chrome) and browse toany website

3. Click on the “Accept and Continue”button on the Terms of Use page thatappears

CONFERENCE FEEDBACK SURVEYYour input is very important to our planning process. Please help improve our conference by completing a quick survey online on Thursday following conference adjournment!

Visit http://bit.ly/2020GMPUGA or scan the QR Code

Find flexibility and specialization all in one place. Recro rises above the competition as the oral solid dosage expert specializing in controlled substances, modified release, and complex formulations to your exact standards. No matter the scope of your project, we deliver — streamlining product formulation and manufacturing from concept to clinic to commercial scale.

Partner with us to produce the pharmaceutical products that get you to the next level.

Let Recro Deliver Excellence.

Elevate YourExpectations

Demand more fromyour CDMO.

DISCOVER RECRO

Visit recrogainesville.com

FormulationDevelopment

AnalyticalServices

RegulatorySupport

Packaging and Logistics

Manufacturing

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Monday, March 9, 2020Time Event Location

5:00-7:00 p.m. Registration Conference Registration Desk

6:00-8:00 p.m. Networking Reception Hill Atrium

Time Event/Topic Location/Speaker7:00-8:30 a.m. Breakfast Buffet Magnolia Room

7:30-8:30 a.m. Late Registration Conference Registration Desk

MORNING SESSION - Mahler Auditorium

8:30-8:45 a.m. Welcome and OrientationDean Kelly M. Smith & Michael Bartlett, University of Georgia

8:45-9:30 a.m. Update from the Office of Regulatory Affairs Alonza Cruse, FDA ORA

9:30-9:45 a.m. Q&A Panel9:45-10:15 a.m. Networking Break Hill Atrium

10:15-11:00 a.m. Risk Management Approaches for Pharmaceutical Manufacturing Systems

R. Derek Glover, Mylan

11:00-11:45 a.m. USP 2020 Jaap Venema, USP

11:45 a.m. - 12:00 p.m. Q&A Panel

12:00-1:00 p.m. Networking Lunch Magnolia Room

AFTERNOON SESSION - Mahler Auditorium

1:00-1:45 p.m. CDER’s Knowledge-aided Assessment and Structured Application (KASA) Program

Larisa Wu, FDA CDER

1:45-2:30 p.m. Quality Metrics – Creating Value Steve Greer, P&G

2:30-2:45 p.m. Q&A Panel2:45-3:15 Networking Break Hill Atrium

3:15-4:00 p.m. Manufacturing and Quality Challenges Associated with Advanced Breakthrough Therapies

Crystal Mersh, QxP

4:00-4:45 p.m. Cyber Security: Hidden Threats In An Automated World

Kurt In Albon, Lonza

4:45-5:00 p.m. Q&A Panel6:30-8:30 p.m. Dinner

“Recent Advances in Biomaterials for Human Health”Magnolia RoomJason Locklin, University of Georgia

AGENDA

Tuesday, March 10, 2020

Time Event/Topic Location/Speaker7:00-8:15 a.m. Breakfast Buffet Magnolia Room

MORNING SESSION - Mahler Auditorium

8:15-9:00 a.m. Data Integrity and Risk Management in Manufacturing Operations

Peter Baker, Green Mountain Quality Assurance

9:00-9:45 a.m. Reviewing Complete Laboratory Data and Improving Analytical Methods to Detect Unexpected Impurities

Heather Longden, Waters

9:45-10:00 a.m. Q&A Panel

10:00-10:30 a.m. Networking Break Hill Atrium

10:30-11:15 a.m. Case Studies from GMP Inspections Ileana Barreto-Pettit, FDA ORA

11:15 a.m. - 12:00 p.m. Inspection Trends and Case Studies Kent Downing, Health Canadaa

12:00-12:15 p.m. Q&A Panel

12:15-1:15 p.m. Networking Lunch Magnolia Room

AFTERNOON SESSION - Mahler Auditorium

1:15-2:00 p.m. Update from the MHRA Graham Carroll, MHRA

2:00-2:45 p.m. The Pharmaceutical Quality System Model-Time for a Facelift?

Cledwyn Davies, Porton Biopharma

2:45-3:00 p.m. Q&A Panel

3:00-3:30 p.m. Networking Break Hill Atrium

3:30-4:15 p.m. Pharmaceutical Quality Systems Application for Big Data, Artificial Intelligence and Extended Reality

Michele Simone, Bracco (Switzerland)

4:15-5:00 p.m. Evidence in the Digital Age-The Impact of Big Data and AI on Analytics and Understanding

Tom Doyle, Medidata

5:00-5:15 p.m. Q&A Panel

5:15-6:45 p.m. Networking Reception Hill Atrium

Enjoy dinner in Athens!See http://bit.ly/gmpdinner for inspiration for your night on the town.

Wednesday, March 11, 2020

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Please don’t forget to give us your feedback!

Visit http://bit.ly/2020GMPUGA or scan the QR Code to complete our survey!

SPONSORS

PROGRAM COMMITTEE

Michael Bartlett, Ph.D. (Chair)University of Georgia

Jennifer AhearnEngineering Systems, Inc.

Robert C. ColemanIHL Consulting

Cledwyn Davies, Ph.D.Porton Biopharma (UK)

Robert Geiger, Ph.D.AmbioPharm, Inc.

Tor GråbergAstraZeneca (Sweden)

Steve GreerProcter & Gamble

Marie MathewsFDA CDER

Crystal MershQuality Executive Partners (QxP)

William MestrandreaCelgene

Alan MinskArnall Golden Gregory, LLP

JoAnn PittmanFDA

Gurvinder Singh Rekhi, Ph.D.University of Georgia

Sam Silva, Ph.D.FK Biotecnologia Sa (Brazil)

Ronald Tetzlaff, Ph.D.Parexel Consulting

Thursday, March 12, 2020

Time Event/Topic Location/Speaker7:00-8:15 a.m. Breakfast Buffet Magnolia Room

MORNING SESSION - Mahler Auditorium

8:15-9:00 a.m. Supplier Qualification Josh Hoerner, Purisys

9:00-9:45 a.m. Considering Risks in CDMO Selection Richard Sidwell, Recro

9:45-10:00 a.m. Q&A Panel

10:00-10:30 a.m. Networking Break Hill Atrium

10:30-11:15 a.m. Techniques for Communicating with Health Authorities Alan Minsk, Arnall, Golden & Gregory

11:15 a.m. - 12:00 p.m.

The Provider Mindset: Practical Tactics for Developing Drug Labeling

Joseph Grillo, FDA CDER

12:00-12:15 p.m. Q&A Panel

12:15 p.m. Conference Adjournment

POST-CONFERENCE TUTORIAL: Room K/L (Second Floor)Session Coordinator: Trina von Waldner

12:15-1:00 Luncheon for Post-Conference Tutorial Participants Magnolia Room

1:00-2:30 p.m. Suppliers and Contract Facilities Governance and Risk Jennifer Ahearn, Engineering Systems

2:30-2:45 p.m. Networking Break Kellogg Concourse

2:45-4:00 p.m. Suppliers and Contract Facilities Governance and Risk (continued)

Marie Mathews, FDA CDERAl Jacks Vero Biotech

4:00 p.m. Post-Conference Adjournment

Continuing Education (CE) credit available through this tutorial only.

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Ms. Ahearn specializes in pharmaceutical and medical device regulatory compliance. She has served numerous roles within the FDA including bench chemist, domestic and international investigator, technical liaison for FDA’s Office of Criminal Investigations, and member of FDA’s National Training Cadre making her an expert in the interpretation and application of cGMP regulations in 21 CFR 210/211 relating to pharmaceutical manufacturing. Ms. Ahearn has assisted pharmaceutical and medical device companies preparing for FDA inspections, as well as responding to FDA 483 observations after an inspection. She has worked to resolve technical and FDA compliance issues for virtually all pharmaceutical dosage forms and medical device classes.

“Suppliers and Contract Facilities Governance and Risk”Thursday, 1:00-2:30 p.m.

JENNIFER AHEARNENGINEERING SYSTEMS

SPEAKER INFORMATIONKURT IN ALBON

LONZA

Peter E. Baker spent 11 years as an FDA Drug Investigator, with 7 of those years spent working in FDA’s overseas offices located in India, China and Chile. Peter was named FDA Investigator of the Year in 2013 for his work uncovering serious breaches in data integrity, and has special interest in big data management and compliance with 21 CFR Part 11. He speaks Chinese (Mandarin) and Spanish, and has performed more than 100 foreign drug inspections around the world on behalf of the FDA. Peter holds a Bachelor of Science (B.S) degree in Biology-Chemistry from Point Loma Nazarene University, a Masters of Science (M.S.) in Chemistry from San Francisco State University, and is an active member of PDA and ISPE.

“Data Integrity and Risk Management in Manufacturing Operations”Wednesday, 8:15-9:00 a.m.

PETER E. BAKER GREEN MOUNTAIN

QUALITY ASSURANCE CAPT Barreto-Pettit is currently an FDA Drug National Expert. She is responsible for providing technical and programmatic expertise to the field and Centers and provides inspectional and technical assistance to field and foreign offices on pharmaceutical inspections and regulatory matters. She joined FDA in 1999 as an Investigator in the FDA San Juan District in Puerto Rico and transferred to the Florida District in 2003. Since then, she has conducted hundreds of inspections worldwide. CAPT Barreto-Pettit is a Commissioned Officer in the U.S. Public Health Service and has over 30 years of combined federal service.

“Case Studies from GMP Inspections”Wednesday, 10:30-11:15 a.m.

ILEANA BARRETO-PETTIT

FDA ORA

Michael G. Bartlett is the Georgia Athletic Association Professor in Pharmacy and Interim Assistant Dean for Nontraditional Education and Outreach at the University of Georgia, College of Pharmacy. His research program focuses on the development of novel bioanalytical methodology to advance drug development including oligonucleotide therapeutics, protein and small molecule biomarkers, and determining the pharmacokinetics and metabolism of new molecular entities. He has been the chair of the program committee for the International GMP Conference since 2015.

“Welcome and Orientation”Tuesday, 8:30-8:45 a.m.

Graham Carroll joined the MHRA as a GMDP Inspector in 2013 before becoming a GMDP Operations Manager in 2017. In 2019 he also became a Senior Inspector. Graham is a Mechanical Engineer (MEng) by training. Prior to joining the MHRA he spent eight years working in the pharmaceutical industry in the areas of human plasma fractionation and sterile product manufacturing; this included operational and managerial roles in Validation and Quality Assurance. Graham specialises in the inspection of sterile product manufacture as well as the collection, processing and supply of blood and blood components.

“Update from the MHRA”Wednesday, 1:15-2:00 p.m.

Alonza Cruse is Director, Office of Pharmaceutical Quality Operations (OPQO) within the FDA Office of Regulatory Affairs (ORA). His office is responsible for all pharmaceutical quality inspections and investigations, working in conjunction with FDA’s Center for Drug Evaluation & Research (CDER) and Center for Veterinary Medicine (CVM). Additionally, Mr. Cruse continues to lead ORA’s pharmaceutical collaboration efforts under the program alignment initiative.

From 2013 - 2015 Mr. Cruse served as the Director (Acting) of the Office of Medical Products & Tobacco Operations (OMPTO) within ORA, overseeing activities such as Generic Drug User Fee Amendments (GDUFA) implementation, pharmacy compounding, and the development of a New Inspection Protocols Program (NIPP). From 2000 - 2015, Mr. Cruse was the Director, FDA’s Los Angeles District Office, where his responsibilities included providing executive leadership to implementing, managing and evaluating FDA’s regulatory operations. Mr. Cruse first joined ORA in 1983 as a microbiologist. He received his Bachelor of Science degree in Medical Technology from York College (City University of New York).

“Update from the Office of Regulatory Affairs”Tuesday, 8:45-9:30 a.m.

MICHAEL BARTLETT GRAHAM CARROLL

ALONZA CRUSE

UNIVERSITY OF GEORGIA MHRA

FDA ORA

Kurt In Albon began his career In 1995 as computer scientist with the pharmaceutical contract manufacturing organization Lonza in Switzerland. For several years he was involved in the development and customization of a number of corporate and global computerized systems. In the late 1990s he was in a leading role in the development, implementation, and training of modern risk-based validation standards to support compliance with the increasingly important requirements regarding computer systems validation. He subsequently moved to Lonza Group’s global quality organization and was instrumental in the design and implementation of the company’s data integrity initiative related to electronic systems. In 2010 he obtained a degree in pharmaceutical validation technology. Together with his team he works on the global information systems quality policies, standards, and procedures, to ensure Lonza’s information infrastructure and systems remain on the cutting edge of information quality.

“Cyber Security: Hidden Threats In An Automated World”Tuesday, 4:00-4:45 p.m.

Cledwyn Davies is Compliance Specialist and Qualified Person at Porton Biopharma Ltd., based at Salisbury in the UK.

Dr. Davies has a PhD in Microbial Biochemistry from the University of Wales and has been an EU Qualified Person since 1993, specializing in sterile products, biologicals and biopharmaceuticals. He has over 35 years’ experience of implementing and managing Quality Control and Quality Assurance systems in pharmaceutical manufacture, development and testing, including the site-wide introduction of ISO 9001. He has been a participant in commercial development and biodefence programs for the US and UK governments. More recently he has been a member of the Steering Group of PDA’s Global Quality Interest Group.

“The Pharmaceutical Quality System Model-Time f or a Facelift?”Wednesday, 2:00-2:45 p.m.

CLEDWYN DAVIESPORTON BIOPHARMA

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Mr. Jacks joined Vero Biotech as SVP, Quality Assurance in 2019, and has nearly thirty years of experience in the pharmaceutical and medical device industries. Prior to Vero Biotech, he served as VP, Quality Assurance and Operations for Alimera Sciences Inc., where he was responsible for managing the company’s global supply chain, manufacturing, and quality systems. He previously held VP-level QA/RA positions at CR Bard, J&J, and numerous start-ups.

Over the course of his career, Mr. Jacks has successfully implemented multi-site global quality management systems that meet FDA and international compliance requirements for pharmaceuticals, medical devices, and combination products, and he is passionate about improving organizational performance, implementing best-in-class business processes, and achieving sustained regulatory compliance.

Mr. Jacks began his career at Glaxo Inc. (now GSk), where he contributed on drug numerous development project teams, first as an analytical scientist and later in Regulatory Affairs, responsible for IND phase 1 & 2 CMC submissions and R&D Quality Assurance. Mr. Jacks holds an MS in Chemistry from Illinois State University and a BS in Biology from Northern Illinois University.

“Suppliers and Contract Facilities Governance and Risk”Thursday, 2:45-4:00 p.m.

Dr. Grillo is the Associate Director for Labeling and Health Communication for the Office of Clinical Pharmacology (OCP) in the Center for Drug Evaluation and Research of the United States Food and Drug Administration.

Prior to this Dr. Grillo was a senior clinical pharmacologist in OCP focusing extensively on developing and implementing the Office’s physiologically-based modeling (PBPK) program.

Dr. Grillo received his Doctor of Pharmacy degree in 1993 from Virginia Commonwealth University followed by a two-year post-doctoral fellowship in critical care pharmacotherapy and emergency medicine.

Dr. Grillo was on faculty in the Departments of Pharmacy Practice at St. John’s University and Shenandoah University and is currently an Affiliate Associate Professor of Pharmaceutics at Virginia Commonwealth University.

Dr. Grillo has conducted independent research while in academia and at FDA in the areas of pharmacy education, critical care, acute cardiac care, clinical pharmacology, PBPK modeling, and regulatory science.

“The Provider Mindset: Practical Tactics for Developing Drug Labeling”Thursday, 11:15 a.m. - 12:00 p.m.

VERO BIOTECH

FDA CDER

Jason Locklin obtained his BS from Millsaps College in 1999. He graduated with his MS from UAB in Chemistry in 2002 and PhD from the University of Houston in 2004. Jason then went on as a Director of Central Intelligence Postdoctoral Scholar at Stanford University in 2005 in the Department of Chemical Engineering. In 2007, Locklin joined the University of Georgia in the Department of Chemistry and the College of Engineering and was promoted to Professor in 2018. He founded the New Materials Institute in 2016 that focuses on green engineering principles and circular materials management.

Locklin has been awarded the Central Intelligence Agency Young Investigator Award (2007), NSF CAREER Award (2010), the Northeast Georgia ACS Chemist of the Year for Research (2009-2010), and the Atlanta Magazine Groundbreaker Award (2011). He is a Distinguished Faculty Scholar in the College of Engineering and the Site Director for the National Science Foundation Industry University Collaborative Research Center -- Center for Bioplastics and Biocomposites at UGA.

“Recent Advances in Biomaterials for Human Health”Tuesday, 6:30-8:30 p.m.

JASON LOCKLINAL JACKS

JOSEPH GRILLO

UNIVERSITY OF GEORGIASteve Greer is the External Engagement

Leader in Corporate Quality Assurance for the Procter & Gamble Company. Steve is responsible for building collaborative relationships with boards of health and industry as well as strengthening internal GMP capability. In 2017, he was awarded the James N. Gamble Award, the highest recognition to individuals in Quality Assurance who have made outstanding leadership contributions.

Steve is on the core team of the ISPE Advancing Pharmaceutical Quality initiative. He is also co-chair of the Quality Assurance Committee of the Personal Care Products Council and previously served as the chairman of the Pharmaceutical Industry Association of Puerto Rico’s QA committee.

Steve is a keynote and workshop speaker on leadership and quality at many conferences. He is an executive/leadership coach helping people create “genesis moments” in their leadership and lives. Steve and his wife also lead Genesis Counseling Center with offices in Virginia where they serve over 5,000 clients a month.

He can be contacted at greer.sa@pg.com, sgreer@genesisassist.com on the web at www.genessisassistcoaching.com and on LinkedIn: www.linkedin.com/in/steveagreer

“Quality Metrics – Creating Value”Tuesday, 1:45-2:30 p.m.

STEVE GREERP&G

R. Derek Glover serves as the Global Head of Quality for Mylan NV, a leading pharmaceutical company, and has been with the company for more than 23 years. Derek is a graduate of West Virginia University, USA where he received a B.S. degree in Chemistry, a B.A. degree in Biology and a B.A. degree in Liberal Arts (science concentration).

Derek served as a combat medic in the US Army National Guard and the US Army from 1985 to 1993 and he served in Operations Desert Shield and Desert Storm in 1991. After starting his pharmaceutical career as a Quality Control chemist, he has previously held various positions of increasing responsibility including, but not limited to, Site Head of Quality Control, Site Head of Quality Compliance, Site Head of Quality, North America Head of Quality, and Global Head of Quality Systems, Compliance and Remediation. He participates in various industry forums and actively partners with regulators and special interest groups to shape policy and provide training on key topics such as Data Integrity, Laboratory Controls and Process Validation. Derek passionately believes in Mylan’s mission of providing affordable, high quality healthcare to the world’s 7 billion people and works tirelessly to continue to raise the quality standards for pharmaceutical products everywhere.

“Risk Management Approaches for Pharmaceutical Manufacturing Systems”Tuesday, 10:15-11:00 a.m.

R. DEREK GLOVERMYLAN

Tom is a recognized technology and innovations leader with over 18 years of experience focused on the intersection of technology, life sciences, and analytics to accelerate clinical development, optimize supply chain, and launch novel therapies. 

As Senior Vice President of Data Science, Tom leads Medidata’s data fabric vision and the development of novel data products powering Acorn AI on top of the world’s richest integrated and standardized clinical data set. Since joining Medidata in 2019, Tom has championed the data fabric and the use of technologies in machine learning (ML), natural language processing (NLP), and semantics.

Prior to joining Medidata, Tom led the Data Science practice for one of the world’s largest life sciences companies. He led the exploration and development of cutting-edge ML and NLP based solutions in areas such as clinical trial feasibility, disease prediction, sales force effectiveness, and patient persistence.

“Evidence in the Digital Age-The Impact of Big Data and AI on Analytics and Understanding”Wednesday, 4:15-5:00 p.m.

TOM DOYLEMEDIDATA

Kent Downing is a Health Canada GMP Inspector based in Vancouver on the West Coast of Canada. He has been with Health Canada for 12 years in his role as a Compliance and Enforcement Specialist performing GMP inspections for both active pharmaceutical ingredients and finished dosage forms. He has been active on Health Canada’s GMP Committee since 2008, was former Chair of the National Inspection Rating Review Group (IRRG) and been involved in the drafting of Canadian GMP guidances. From 1999 to 2008, he worked for multiple drug developers, with increasing management responsibility in drug development, drug GMP manufacturing and quality.

“Inspection Trends and Case Studies”Wednesday, 11:15 a.m. - 12:00 p.m.

KENT DOWNINGHEALTH CANADAA

Josh Hoerner leads the innovation function for Purisys and is the Managing Director of the Athens, Georgia site, Purisys’ global headquarters. Josh oversees the core product development functions, the reference standard program and CDMO strategic business units, the small-scale commercial manufacturing facility, global manufacturing technical support, applications development, customer technical services, and the quality and regulatory functions. Josh is also a central member of Purisys’ intellectual property team. He has more than 15 years of industry experience encompassing API and DP development (solid oral and parenteral dosage forms) working at Pfizer, Merck, J&J, and General Electric. Josh’s prior experience includes both new chemical entity and generic product experience as well as lifecycle management. Josh holds a Ph.D. in Bioanalytical Chemistry from the University of Massachusetts and B.S. in Chemistry from Hobart and William Smith Colleges.

“Supplier Qualification”Thursday, 8:15-9:00 a.m.

JOSH HOERNERPURISYS

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Larisa Wu, Ph.D., is a Senior Chemist in the Immediate Office of the Office of Pharmaceutical Quality (OPQ), FDA. Since she joined FDA in 2011, Larisa contributed significantly to various initiatives that became pivotal to the launch of OPQ, including integrated team-based quality assessment, risk-based review, and ANDA backlog review and management. In her most recent role as Special Assistant, Larisa worked extensively on several FDA, CDER, and OPQ initiatives including: Knowledge-aided Assessment and Structured Application (KASA), Concept of Operations (ConOps) for Inspection of Human Drugs, Process and Facility Integration, OPQ Secondary Assessment, and BARDA-FDA Drug Shortage Program. Her contributions have been recognized in award ceremonies at the agency, center, and office level. Larisa received her Ph.D. degree in Bioengineering from University of Utah, followed by a postdoctoral fellowship in Pharmaceutical Sciences at University of Maryland, School of Pharmacy. She also holds an M.S. degree in Chemistry and a B.S. degree in Biomedical Engineering.

“CDER’s Knowledge-aided Assessment and Structured Application (KASA) Program”Tuesday, 1:00-1:45 p.m.

LARISA WU, PH.D.FDA CDER

Jaap Venema, Ph.D., Executive Vice President and Chief Science Officer (CSO) for USP, leads the organization’s scientific strategy and is responsible for the development of quality standards for medicines, dietary supplements, food ingredients and healthcare, including collaborations with other pharmacopeia and scientific groups. Dr. Venema also guides exploration of emerging technologies that may inform future quality standards; oversees USP’s Up-to-Date program, which continuously evaluates and revises standards to reflect current and best practice; and serves as Chair of USP’s Council of Experts. With more than 25 years’ experience in global research and development, as well as academic research, Dr. Venema previously served in a variety of scientific leadership positions at Solvay and AbbVie (formerly Abbott Laboratories). A native of the Netherlands, Dr. Venema earned his Master’s degree in Chemistry from the Free University of Amsterdam, and his Ph.D. in Biochemistry and Molecular Biology from Leiden University in the Netherlands.

“USP 2020”Tuesday, 11:00-11:45 a.m.

JAAP VENEMAUSP

Senior Vice President and Chief Scientific Officer – Recro Gainesville LLC

Richard Sidwell serves as senior vice president and chief scientific officer for Recro Gainesville. Dr. Sidwell is responsible for Recro’s overall scientific strategy for the CDMO business. He has worked at the Gainesville site since 2003, experiencing the site’s evolution from Elan Drug Technologies to Alkermes in 2011 and finally to Recro in 2015. While at Recro, Dr. Sidwell has been instrumental in leading and building the CDMO’s product development team, which focuses on bringing innovative solutions to its clients.

With 25 years of pharmaceutical development experience, Dr. Sidwell is recognized as a thought leader in pharmaceutical formulation and process development for oral solid dosage forms, multi-particulate controlled release formulations, and abuse-deterrent formulations for controlled substances. Dr. Sidwell holds multiple patents and publications in these areas.

Dr. Sidwell earned his Ph.D. in pharmaceutics from the University of Georgia; master’s of science degree in health physics from the Georgia Institute of Technology; and bachelor’s of science degree in physics from Oglethorpe University. He is an active member of the American Association of Pharmaceutical Scientists (AAPS).

“Considering Risks in CDMO Selection”Thursday, 9:00-9:45 a.m.

RICHARD SIDWELL, PH.D.

RECRO

Dr. Kelly M. Smith is Dean and Professor of Clinical and Administrative Pharmacy at the University of Georgia College of Pharmacy. A BSPharm and PharmD alumna of the College, Dean Smith held several practice, faculty and administrative roles at the University of Kentucky before returning to her alma mater. A recognized leader in pharmacy education and training, she created the nation’s first statewide coalition to foster residency program growth and collaborated to develop the profession’s first residency teaching certificate program. She has received several honors during the course of her career, including Pharmacist of the Year by the Kentucky Society of Health-System Pharmacists and the Kentucky Pharmacists Association. She is immediate past-president of the 55,000 member American Society of Health-System Pharmacists (ASHP), and received Zeta Tau Alpha Foundation’s 2018 Outstanding Alumna Award in recognition of her national leadership in Pharmacy and Pharmacy education. Dean Smith is a Fellow of ASHP and the American College of Clinical Pharmacy.

“Welcome and Orientation”Tuesday, 8:30-8:45 a.m.

UNIVERSITY OF GEORGIA

KELLY SMITH, PHARM.D.

Alan G. Minsk is a Partner and Leader of the Food & Drug Practice Team of Arnall Golden Gregory LLP, an Am Law 200 law firm located in Atlanta, Georgia and Washington, D.C. Mr. Minsk advises pharmaceutical, biologic, medical device, cosmetic and food companies (including dietary supplements and medical foods) on all legal and regulatory matters relating to the U.S. Food and Drug Administration. He counsels clients on a wide variety of FDA-related issues including regulatory strategies and life cycle management, combination products, FDA enforcement, FDA inspections, corporate compliance, market exclusivity, product promotion and advertising, product liability, clinical trials and imports and exports. Mr. Minsk is nationally recognized by Chambers USA for “Life Sciences: Regulatory/Compliance,” has been selected for inclusion in the international publication of Who’s Who Legal for “Life Sciences: Regulatory,” and is recognized by Best Lawyers for “FDA Law.”

“Techniques for Communicating with Health Authorities”Thursday, 10:30-11:15 a.m.

ALAN G. MINSKARNALL, GOLDEN

& GREGORY

Dr. Michele Simone is Director of Corporate Quality Management for Bracco Suisse SA in the pharmaceutical imaging product operations in Lugano, Switzerland, where he is responsible for Group Quality Management Review, Complaints Management, Auditing, Quality Risk Management, Knowledge Management, CAPA Management and Continual Improvement. Over 25 years’ experience in the pharma/biopharma industry. Michele hold a number of different roles during his career, including: Microbiology and Environmental Monitoring Supervisor, QA GMP Compliance Site Manager of a sterile fill-finish facility (liquids, lyophilized vials, pre-filled syringes, cartridges), QA/QC Senior Site Manager of a medical device J&J facility (coronary coated stents) with a broad international scope, Global Quality and Training Senior Manager (site and corporate quality) of a Parenteral network of J&J facilities, Head of Quality System and Compliance of two Novartis V&D Vaccines facilities manufacturing APIs and finished dosage forms, Corporate Quality Auditor for API, Finished products, Chemical, Consumer, Commercial Affiliates, Vendors at Merck KGaA.

“Pharmaceutical Quality Systems Application for Big Data, Artificial Intelligence and Extended Reality”Wednesday, 3:30-4:15 p.m.

Crystal Mersh is President and CEO of Quality Executive Partners Inc. After 25 years in industry with companies such as Novartis, Mylan, Sanofi and Allergan, and experiencing the need for a revolutionary approach to consulting that delivers long-term transformational change, she established QxP. QxP engages in thought leadership on the leading edge of manufacturing technologies to include regenerative medicine and immuno therapies. QxP is committed to influencing of regulatory and industry standards, and setting the platinum standard in life sciences education with the development and launch of Virtuosi.

“Manufacturing and Quality Challenges Associated with Advanced Breakthrough Therapies”Tuesday, 3:15-4:00 p.m.

MICHELE SIMONE

CRYSTAL MERSH

BRACCO (SWITZERLAND)

QXP

Marie Mathews is a compliance officer with the FDA, CDER Office for Manufacturing Quality. She spent nine years as an FDA investigator, conducting inspections of a wide variety of domestic and international manufacturers, including medical devices and drug firms. She led several criminal investigations, including a major medical device prosecution case for FDA. Ms. Mathews has received several awards from FDA, including the Individual Commendable Service Award. She received both her Bachelor of Science and Masters of Science in Pharmacy with an emphasis in Regulatory Affairs from the University of Georgia.

“Suppliers and Contract Facilities Governance and Risk”Thursday, 2:45-4:00 p.m.

MARIE MATHEWSFDA CDER

After a number of years in training, supporting and selling Waters Software, Heather’s current role is as a specialist in compliance to e-record regulations, acting as a resource to the global informatics community at Waters and the users of all Waters informatics products.

This involves helping design the compliance into Waters informatics products and services, attending and presenting at specialist conferences, keeping up to date on the latest interpretations and amendments to the regulations and disseminating this information to the Waters field and corporate organizations.

“Reviewing Complete Laboratory Data and Improving Analytical Methods to Detect Unexpected Impurities”Wednesday, 9:00-9:45 a.m.

HEATHER LONGDENWATERS

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Building trust through the community by fulfilling promises

Athens, Georgia • Royston, Georgia • Union, Missouri

www.pharma-tech.com

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See and preview our demo video recording athttp://fdasmart.com/UofG/InternationalGMPppt.html https://drive.google.com/open?id=1FzZDh9wDFObG-TtZj_JiglvJ3XJazEZU (click & play !)

Email: rbalani@fdasmart.com or SMS or Call 201 913 0558 for further inquiries or to request an online demo

A Microsoft Partner company

Building trust through the communityby fulfilling promises

Athens, Georgia • Royston, Georgia • Union, Missouri

www.pharma-tech.com

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Harnessing the power of the immune system

to help patients live longer.

Founded on the belief that immunotherapy made from a patient’s own cells holds the key to the future of cancer care, Dendreon is fighting for patients by making the battle against cancer personal.

Dendreon.com

At Osmotica, People and Patients Come First!

START A NEW JOURNEY WITH US!

CAREERS.OSMOTICA.COM OOUURR PPUURRPPOOSSEE AATT OOSSMMOOTTIICCAA is to make a true difference in the lives of our patients, employees and stakeholders by delivering innovative pharmaceutical solutions and approaching all we do with integrity, ownership and excellence. We accomplish this by living six core values every day.

As one of the world's leading osmotic drug delivery companies, we leverage our significant resources in R&D

and proprietary drug delivery technology to address the growing need of the global patient population. WWhhaatt ddooeess iitt mmeeaann ttoo jjooiinn oouurr tteeaamm??

As a member of our team, we are confident you will bring your own unique talents to help us continue to build

a world-class pharmaceutical company that helps improve the health and well-being of those who rely on our

products. In return for your efforts, we will always strive to provide you with the kind of stimulating, challenging,

and pleasant work environment that fosters career development, professional advancement opportunities,

rewards, and personal growth.

Osmotica is committed to leveraging the talent of a diverse workforce, creating great opportunities for our people and

our organization. All qualified applicants will receive consideration for employment without regard to race, color, religion,

sex, sexual orientation, gender identity, national origin, disability, or veteran status.

SAVE THE DATE

44th International Good Manufacturing Practices ConferenceMarch 9-12, 2020 | Athens, GA

GMP 2020