home   genetic news   bioinformatics   biotechnology   literature   journals   ethics   positions   events   sitemap
 
  HUM-MOLGEN -> Events -> Meetings and Conferences  
 

Process Validation Guidance Requirements (FDA and EU Annex 15: Qualifications and Validation)

 
  May 20, 2021  
     
 
ComplianceOnline, Virtual Training Through WebEx
14/6/21


DAY 01(10:00 AM TO 4:00 PM EDT)
  • 10.00 AM: Session Start
  • Introduction, Goals and Objectives, Definitions. Process Validation - Its Importance within the Drug Industry
  • Interaction of the Three Stages with Process Validation
  • Validation Approaches, cGMPs in Clinical Supply Manufacture, Special Manufacturing Situations within Phase 1
  • The Requirements of Phase 1 Investigational Drug Requirements
  • Regulatory Strategies for Phase 2 and 3 and their Incorporation within Stages 1 and 2
DAY 02(10:00 AM TO 4:00 PM EDT)
  • General Considerations for Process Validation – Stage 2 Process Qualifications
  • Special Considerations for Process Validation – Stage 2
  • General Considerations for Process Validation – Stage 3 Continued Process Verification
  • A Review of EU Annex 15 and its Comparison to FDA’s Process Validation Guidance
  • Concurrent Release of Process Performance Qualification (PPQ) Batches
  • Analytical Methodology and Process Validation; Warning Letter examples
 
 
Organized by: ComplianceOnline
Invited Speakers:

Barry A. Friedman, PhD, is a Consultant in the Biotechnology, Regulatory Compliance and Aseptic Processing Arena. Dr. Friedman possesses over 30 years of industrial managerial experience in various aspects of biopharmaceuticals and medical devices to include regulatory compliance, expert witness testimony, GLP/GMP, quality control, auditing, sterility assurance, microbiological/analytical validations and fermentation technology.

Prior to becoming an independent consultant, Dr. Friedman was associated with Cambrex Bio Sciences, a contract manufacturer of GMP bulk biopharmaceuticals located in Baltimore, Maryland. As the Director of Quality Control, he managed a multi-shift Department of thirty one individuals involved in client management, the receipt and testing of raw materials, environmental monitoring and microbiology, analytical chemistry and QC compliance for the production of Phase 1, 2, 3 and commercial products manufactured from bacteria, yeast and mammalian cells. In this capacity, Dr Friedman enjoyed many client and regulatory interactions, both domestic and international.

Prior to 2000, Dr. Friedman was the Laboratory Director for Chesapeake Biological Laboratories, a contract Aseptic Fill n’ Finish manufacturer located in Baltimore, Maryland. In addition to the professional history listed above, other associations have included W.R. Grace, Sigma Chemical Co., Sherwood Medical, Becton Dickinson, American Cyanamid and Union Carbide.

Dr. Friedman received his B.S. degree in Microbiology from Ohio State University, his M.S. from Michigan State University in Microbial Genetics, and his PhD from Ohio State University in Microbiology.

 
Deadline for Abstracts: 10/6/21
 
Registration:
$1,699*
(Seminar for One Registration)
June 14-15, 2021, Virtual Seminar

Register now and save $300 (Actual Price: $1,999)

E-mail: referral@complianceonline.com
 
   
 
home   genetic news   bioinformatics   biotechnology   literature   journals   ethics   positions   events   sitemap
 
 
 

Generated by meetings and positions 5.0 by Kai Garlipp
WWW: Kai Garlipp, Frank S. Zollmann.
7.0 © 1995- HUM-MOLGEN. All rights reserved. Liability, Copyright and Imprint.