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Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment - Issues and Solutions

 
  February 03, 2021  
     
 
ComplianceOnline, online event
25 February 2021


DAY 01(10:00 AM - 4:00 PM EST)
  • 10.00 AM: Session Start
  • Compare and Contrast FDA, Health Canada, ICH, USP and EP requirements.
  • The various raw materials and the user impact
  • Impact of raw materials in the timely production of a product
  • The impact of the single most used raw material in large molecule production and its impact upon the user
  • The regulatory requirements for Phase 1 through commercial manufacturing
  • The use of additional testing – does one only review the C of A
DAY 02(10:00 AM - 4:00 PM EST)
  • The use of compendial testing in lieu of non-compendial testing – pros and cons
  • Regulatory risk (ICH Q9) with raw materials
  • Testing requirements – how to sample
  • Testing requirements – how to test
  • The impact of ASQ and square root of N+1 on sample size and attribute testing
  • Case Studies – Time to apply the previous two days
  • 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 The Ohio State University in Microbiology.

 
Deadline for Abstracts: 23.2.2021
 
Registration: Register by phone or need assistance? Call +1-888-717-2436

E-mail: referral@complianceonline.com
 
 
   
 
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