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INTERACTIVE
WEBINAR
 
 
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Learning the Differences Between

GLPs vs.  GMPs  

A Comparison and Contrast

April 11,2017 Webinar

12:00 pm – 1:30 pm EDT

Periodically one hears the comment that “a laboratory or a manufacturing facility meets 21 CFR Part 58 and therefore they meet all of the cGMP requirements”. Contrary to popular belief, 21 CFR Part 58 is not the equivalent of 21 CFR 210/211 and does not meet the same requirements as 210/211. They (Part 58) do have the force of law and are not “watered down” GMPs.

Good Manufacturing Practice (cGMPs) represents that part of Quality Assurance that ensures that products are consistently produced and controlled to the Quality standard appropriate to their intended use and as required by the product specification.

Non-clinical laboratory studies (21 CFR Part 58.1) support or are intended to support application for research or marketing permits for the following products to include:
• Food and color additives
• Human and animal drugs
• Medical devices for human use
• Biological Products
• Electronic Products


GLPs do not include manufacturing product.  Non-clinical Laboratory Studies (58.3) include in vitro or in vivo experiments in which test articles are studied prospectively in test systems under laboratory conditions to determine their safety. This does not include studies utilizing human subjects or clinical studies or field trials in animals.

The Objective of this live, interactive training webinar will be to explore Good Laboratory Practice (GLP) and contrast it against Good Manufacturing Practice (GMP). Please plan to bring a team to this Webinar to explore how these issues may assist you in your facilities.
 

By attending you will learn about the following:

  • Gain insight into “Good Laboratory Practices” (21 CFR Part 58)
  • Learn what GLPs are and are not.
  • Understand the Basic Elements of GLP.
  • Learn about Management Responsibilities and “Sponsors”.
  • Understand the Quality Assurance Unit Responsibilities
  • Understand the Purpose of the Study Protocol and its Importance in Conducting Acceptable Studies
  • Determine the Elements of a Final Report and Why they are Important
  • Compare and Contrast all of the above GLP Elements with Good Manufacturing Practice (GMP).

Instructor:  Barry A. Friedman, Ph.D.

About the Instructor:

Barry A. Friedman, Ph.D., is a Senior Consultant in the Biotechnology, Regulatory Compliance, Microbiology and Aseptic Processing arena. From 2000 to 2007, Dr. Friedman was associated with Cambrex Bio Science Baltimore, a contract manufacturer of GMP bulk biopharmaceuticals located in Baltimore, MD. In that capacity as the Director, 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 compliance interactions.

Dr. Friedman has over 30 years of industrial managerial experience in various aspects of biopharmaceuticals and medical devices to include regulatory compliance, expert witness assistance, quality control, sterility assurance, microbiological/analytical validations and fermentation technology. In addition to the associations listed above, other associations have included Chesapeake Biological Laboratories, W.R. Grace, Sigma Chemical Co., Sherwood Medical, Becton Dickinson, American Cyanamid and Union Carbide.

Dr. Friedman is a frequent seminar and webinar speaker and specializes in the areas of regulatory compliance, internal auditing, aseptic processing for sterile drug products, USP and Warning Letter “dissection”, multi-departmental interactions, validations and the requirements for the manufacture of Phase 1, 2 and 3 clinical trial materials. He has recently given presentations for the FDA, PDA, PTi, TungstenShield, IPA (Canada) and Pharmig (UK). He maintains an active Blog (www.barryafriedmanphdllc.com) that contains over 180 Blogs that address various Warning Letter and FDA 483 issues.  He is a member of ASM, PDA and RAPs. He served as a Captain in the Medical Service Corps, U.S. Army and is the past President and current Treasurer of the Capital Area Chapter, PDA. He recently received the James Agalloco award from PDA which is awarded to a PDA faculty member who exemplifies outstanding performance in education.

Fee:

$385 for one person
$700 2-5 people
$999 6-10 people

REGISTER NOW!  CLICK HERE!

 
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