Thursday, August 23

8:00 am Morning Coffee & Unit 3 Registration

8:30 – 12:00 Unit 3: Dealing with Regulations

8:30 Auditing Bioanalytical Method Validation and Sample Analysis The purpose of this talk is to share with the audience the key elements auditors are looking for during an audit. The scope of the presentation is on auditing data and reports for bioanalytical method validation and sample analyses. In addition, I will engage the audience to discuss the rationale of laboratory do’s and don’ts. My talk will demystify what QA professionals are looking for when auditing data and reports for bioanalytical method validation and sample analyses. The scientists can apply what they learn from this talk to their everyday work. As a result, their work is more compliant and is subject to less scrutiny from QA audits. Rosaline Wang, Compliance Manager, GLP Compliance, Amgen, Inc. Dr. Wang has ten years of experience in quality and compliance in the pharmaceutical/biotech industry. Currently, she is working as GLP auditor at Amgen Inc. Prior to working at Amgen, she worked as QA Manager at Alta Analytical Laboratory and QA/QC Chemist at 3M Pharmaceuticals. 10:00 – 10:30 Networking Coffee Break and Exhibit Viewing 10:30 FDA 483 Warning Letters In coming to understand FDA 483s and the potential for subsequent warning letters we will begin with an overview of FDA inspections and related regulations. Our discussions will include preparing for an inspection and the hosting of an FDA inspection. We will cover and assess the nature of the most common types of observations documented by field inspectors on Form FDA 483. Having received a 483, we will discuss a pragmatic approach to providing effective responses in a timely manner. Patrick L. DeVillier, M.S., RAC, Senior Director of Compliance, AP Pharma Mr. DeVillier has worked 23 years for companies regulated by FDA and other international regulatory agencies. Post obtaining his undergraduate degree in Chemistry, Mr. DeVillier spent 10 years at Bayer AG in Berkeley, California working in Quality Assurance and supervising the separation and purification of cell-derived and plasma-derived proteins in their CGMP manufacturing plants. In 1993, Mr. DeVillier accepted a position as an Analytical Chemist with AP Pharma in Redwood City, California and is now their Senior Director of Compliance responsible for quality assurance and regulatory affairs. Mr. DeVillier has extensive experience with the designing and implementation of quality systems, auditing of GxP environments, technical writing, regulatory submissions, and pre-approval inspections. Mr. DeVillier is a member of ACS, RAPS, ASQ, SQA, and holds certifications in Regulatory Affairs and Quality Assurance. Mr. DeVillier is presently the Chairman of the GMP Specialty Section for SQA. He earned his Masters of Science degree at Sonoma State University, California combining Physics and Education in an Interdisciplinary Studies Program.

12:00 – 1:30 pm Lunch Break (on your own)

1:00 – 1:30 Registration for Unit 4

1:30 – 4:45 Unit 4: Beyond the “Home Turf”

1:30 Outsourcing It is usual for a developing pharmaceutical company to outsource pre-clinical work. Even larger companies will use contract laboratories. Most often, a specialist laboratory will be contracted to perform the in vivo toxicology studies which must be done under GLP conditions. However, there are other areas in which outsourcing also makes good scientific and commercial sense, such as the development of highly specialized assays or other in vitro tests. In all cases, the sponsoring company cannot relinquish responsibility for GLP compliance in all pre-clinical studies that will be submitted in the IND or NDA. This seminar will consider the following points relevant to outsourcing: How to identify a suitable contractor for your GLP studies How to set up a contract that will satisfy your needs How to monitor the activities of your contractor to ensure GLP compliance How to transfer developed assays successfully to an in-house laboratory. Alex D. Kanarek, Ph.D., Principal, AK Consulting Dr. Alex Kanarek, Principal of AK Consulting, has more than 30 years of experience in the biopharmaceutical industry with the Wellcome Foundation (now GlaxoSmithKline) in the UK and Connaught Laboratories (now Sanofi Pasteur) in North America. He established his consulting practice in 1993, specializing in regulatory compliance in drug development laboratories and manufacturing plants, technology transfer and biopharmaceutical product development. Dr. Kanarek has written Guides to Good Laboratory Practice, Good Manufacturing Practice, Good Validation Practice, Good Clinical Practice and to Good Facility Design. He is on the editorial advisory board of the BioProcess International journal. Dr. Kanarek received his BS in Microbiology from Imperial College, University of London, his Ph.D. on virus research from Cambridge University and Membership (MCIM) in international pharmaceutical business development from the UK Royal Chartered Institute of Marketing 2:45 - 3:15 Break 3:15 GLP - A European Perspective In a world of “global players” the GLP principles applied on both sides of the oceans are meeting each other. To understand the philosophy, similarities and differences of 21 CFR Part 58 and OECD/EU is the scope of the second part of session 4. Details on the e.g. the inspection practice of European/national monitoring authorities, the conduct of “multi-site studies” and the subtle differences in the GLP languages used will help to avoid surprises when going abroad. Working locally Essential elements for setting-up and running a GLP compliant test site Working globally the GLPs (21 CFR part 58, OECD, european national interpretations) - legal basis and comparison of GLP principles multi-site studies - the new challenge Current trends validation of analytical methods archiving of electronic data Wolfgang Seidel, Ph.D., Head of QA, DMPK, Merck KGaA,Germany Ph.D. in food chemistry 7 years experience in several QC/QA functions in the biotech/pharmaceutical industry Currently head of QA for the GLP test facility DMPK Merck KGaA Member of the DGGF, GDCh and DGQ Speaker at DIA CSV conference 2005 Prague

4:45 End of Conference