8:00 am Registration and Morning Coffee
WRITING SOP’s
8:30 – 11:50 Writing SOP’s (20 minute coffee break included)
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 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
Tutor:
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 B.S. 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.
11:50 – 1:40 pm Luncheon, provided by CHI
1:40 – 5:00 Dealing with Regulations (20 minute refreshment break included)
PLANNING AND CONDUCTING AN AUDIT—HOW TO AUDIT EFFECTIVELY
- Define: first party, second party, third party audits; significance.
- Defining audit objectives; standard(s) or criteria against which the audit is to be conducted.
- Audit process—document audit, system audit, process audit.
- Audit planning—developing audit checklist; objective vs frequency and schedule.
- Pre-audit meeting—communication.
- Audit findings—observations (opportunity for improvement), minor nonconformance, major nonconformance.
- What are they? How to address them?
- End of the Audit meeting; initial communication or preliminary report of audit findings.
- Communication exchange between auditor and auditee.
- Final report.
- Follow-up actions: purpose and procedure.
Tutor:
Lokesh Bhattacharyya, Ph.D., Certified ISO/IEC 17025 Lead Assessor, Interdisciplinary Scientist/Quality Manager, Division of Product Quality, Office of Vaccine Review and Research, Center for Biologics Evaluation and Research, Food and Drug Administration
I worked for 9+ years (1992-2000) in Merck and Co. as a lead analytical biochemist responsible for planning, prioritizing, conducting, and documenting studies to provide analytical support for vaccines and biotechnology-derived proteins under cGMP. I have 6+ years experience in leading and managing the standard setting activities of the US Pharmacopeia (2000-2006) in different capacities, including the Director of the Noncomplex Actives (pharmaceutical drugs) and Excipients Division in the Dept. of Standards Development. At present, I am a staff of the Division of Product Quality (DPQ) of the Office of Vaccine Review and Research (OVRR), Center for Biologics Evaluation and Research (CBER) of the US Food and Drug Administration (FDA) since August, 2006. I served as the Validation Manager until November 2007 and as the Quality Manager since July 2007. I was a faculty at the Albert Einstein College of Medicine, New York (1986-1992), and obtained his Ph.D. (1983) from Calcutta University, India. I published several original research papers and review articles in peer-reviewed journals and presented in several conferences.
Disclaimer: This presentation represents the tutor’s opinion and not the position of the FDA.
5:00 End of Day One
Day 2