Tuesday, January 30, 2018
NOON – 1:30 pm EST
Instructor: Barry A. Friedman, Ph.D.
Knowledge of the microbiology of water in a GMP environment is critical to the health of any water system being used to produce a pharmaceutical or biotechnology product. Even companies manufacturing tablets need to be aware of the quality of the water that may be contacting their process or product. The well-being of a facility revolves around the health of each water system within that facility. How often have we learned of a facility being closed for weeks at a time because of a water system that has exceeded its microbiological specifications?
This live, interactive training webinar presentation will also examine a variety of the issues surrounding water in a facility to include the testing of each water source and to what extent. It will cover testing requirements during commissioning and testing on an on-going basis. The webinar will examine Quality Risk Management (ICH Q9) and discuss how a properly developed Facility Water Validation Plan may lead to a logical, reduced requirement for testing vs. time.
The presentation will explore the time requirement for testing before reduced testing might occur and why some organizations refuse to accept this path.
The objective of this live and interactive Executive Conference Corporation webinar is to assist those involved in the development of a process or the manufacturing of a product to explore water, as a raw material (component) in a GMP environment, the requirements for potable water, purified water, water for injection and steam to assure that they are meeting the current USP, EP, JP and FDA requirements.
By attending, you will learn:
-How to set up a water sampling system and its test frequency.
-Determining the “Health” of a water system based upon test results.
-What are the differences between USP, EP and JP water requirements
-The use of Alert and Action Levels vs. Specifications and what is meant by each.
-When should microorganisms be identified and the preferred methods.
-Understanding the requirements for in-house vs. purchased water.
-Determination of various validations that supplement the maintenance of a USP Purified Water or Water for Injection system.
-How to diagnose and control a water system problem.
$385 for one person
$700 2-5 people
$999 6-10 people
About the Instructor: Barry A. Friedman, Ph.D.
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), Executive Conference Corp., Compliance OnLine, and Pharmig (UK). He maintains an active Blog (www.barryafriedmanphdllc.com/) that contains over 200 Blogs that address various Warning Letter and FDA 483 issues as well as over 1,500 “Search” terms. 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.