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COURSE ID 3090

Management of Pharmaceutical Water in a GMP Environment

AVAILABLE On-demand
90 Minutes

On-Demand

Offering Price
$ 295
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Team Training

When you need on-site attention, we’re not just here to help, we’re there to help—right by your side.

Individual courses are remarkably effective. But sometimes when you have a specific need, it helps to have expert guidance right in the room with you and your team.

In that case, we’re happy to design a custom training for your entire team, whether online—or on-site.

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Remember – at checkout you can choose to take this course On-demand. We offer a 10% group discount when you register 2 of more attendees (up to 10). Contact us for larger groups.

ACCREDITATION CEU's - 0.2 IACET
View Course Outline

This 90-minute course is intended for all scientists and technologists interested in developing a basic understanding or refresher of the basics of microbiology and the ramifications of non-compliance.

The material will be presented in such a way as to be a value to a varying level of expertise. This course will especially benefit those in:
– Facilities
– Regulatory Compliance
– R & D
– Manufacturing
– Quality Control
– Project Management
– Quality Assurance
– Validation

who should
attend?

LEVEL
Intermediate Introductory
INTERESTS
Biotechnology / Biopharmaceutical Pharmaceutical Science & Technology

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 90-minute accredited and interactive training will examine a variety of the issues surrounding water in a facility to include the testing of each unit water operation and to what extent. It will cover testing requirements during commissioning and testing on an ongoing 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 over time.

The training will also explore the time requirement for testing before reduced testing might occur and why some organizations refuse to accept this pathway.

The objective of this 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 (PW), water for injection (WFI) and clean steam to assure that they are meeting the current USP, EP, JP and FDA requirements.

Attending the training with your Project Team will be most beneficial to the group.

course instructor

Barry Friedman Ph.D
Senior Consultant in Biotechnology, Regulatory Compliance, Microbiology and Aseptic Processing

Barry Friedman Ph.D’s Courses
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 is a member of ASM and PDA. He served as a Captain in the Medical Service Corps, U.S. Army, and is the past President and 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.

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