Wednesday, August 22

8:30 Registration and Morning Coffee

9:00 – 12:00 Unit 1: Writing SOPs Compliance with the requirements of a Good Laboratory Practice (GLP) Study Protocol can only be achieved if the analytical methods and other study conduct operations are properly described in written Standard Operating Procedure (SOP) documents. Failure to have adequate study documentation and SOPs shows up frequently in FDA warning letters to institutions having GLP compliance problems. This three-hour seminar will provide attendees with essential tools for the job of creating a compliant SOP system. It will cover: How to develop an effective SOP and write clear, practical instructions How to set up your SOP process so employees know who’s responsible for what and how often to review and update procedures The details to include — and avoid — when drafting a SOP Steps for monitoring and auditing SOP compliance 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

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

1:00 – 1:30 Unit 2 Registration

1:30 – 5:15 Unit 2: Documentation, Validation and Qualification

 

1:30 GLP Compliance -The Challenge for Start Ups: Working Together to Build Strong Documentation Interactive discussion about documentation and tracking in the GLP arena and how to use systems readily available in the lab or through the computer to help develop strong documentation/archiving needed in GLP studies. 1) How: How do you prepare your lab for incoming testing and samples. An example sample will be used to initiate a GLP test 3) Why: Recreate a study through accurate logging and numbering systems. After testing: Reports, QAU, Archiving, pdf files 2) What: What are the basics for a start up? Pre testing:Tracking, Data forms, Sponsors, QAU During testing: Protocol, QAU 4) Continued Improvements Improving templates for all systems, increasing efficiency and building from audit findings Ann Wright, Ph.D., RAC, Principal Scientist, Research Development Technical Support, CIBA Vision Dr. Ann M. Wright has been employed in the contact lens industry for over 14 years. She has made numerous presentations at various professional meetings highlighting the interaction of in vitro tissue culture with contact lens products and materials. She also has professional journal publications on both cellular biology and microbiology. She is a certified regulatory affairs professional and is study director and sponsor for GLP studies for product submissions. She has presented online training, professional organization symposiums and provides both external and internal training to individuals on GLP guidelines. She recently supported the biotechnology initiative for RAPS and CRDF in Kazackhstan. Her career has involved fucosyltransferase studies, P. falciparum tissue culture, recombinant DNA studies with P. putida, education and presently is involved in cell biology/ toxicology methods and immunological assays involved with the contact lens and lens care products. Her undergraduate studies were at Hope College and shereceived doctoral degree in pharmaceutics from Mercer University. 2:30 Information Technology - Infrastructure Change Control The transition for the Information Technology (IT) function from a research / academic mode to a GLP environment can be challenging for the entire organization. Maintaining Electronic data generated by the laboratories requires a comprehensive methodology from backup and restore, hardware/software qualifications, validation and change control. Sam Mistretta, Compliance Specialist, Informatics, CyberVal Pharma, Inc. Degreed in Interdisciplinary Life Sciences/Chemistry at the University of South Florida. Experience with major pharmaceuticals in the Microbiology, Quality Control, and Research & Development laboratories. Microsoft Certified Systems Engineer (MCSE) and laboratory informatics specialist. Last seven years as a consultant to biopharmaceutical, pharmaceutical, and medical device industries. 3:30 – 4:10 Refreshment Break 4:10 GLP Compliance in Bioanalytical Laboratories GLPs are the standards used to assure the quality and integrity of the data and to judge their acceptability during the course of a study. To be compliant with GLP regulations, GLP laboratories need to continuously improve an established GLP system and implement within. This presentation will cover some fundamental points of GLP system and elaborate several important aspects that an organization needs to pay close attention to successful conduct of a study and thus avoiding potential citations or warnings from FDA inspections. Some of practical experiences with FDA and Sponsor inspections/audits will be presented. “What to do or not to do” will be discussed to certain extent for a better understanding of a good “science” as well as good “regulatory science”, especially within Bioanalytical laboratories. These will include principles of GLP, basic terminologies, interpretations and executions for GLP studies. Some strategies will be also discussed, for efficient compliance practices used in the bioanalytical laboratories. Michael Zhou, Ph.D., Science Director, Gorbec Pharmaceutical Svcs Inc.

5:15 End of Day One