The Microbiology of Water in a GMP Environment; USP, EP, JP and FDA Requirements for Potable Water, Purified Water, Water for Injection and Steam

Live, Interactive Training Webinar

Date: Wednesday October 24, 2018 - Time: 9:30 AM - 11:30 AM ET
Barry A. Friedman Ph.D. Biography>>>

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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 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 following this time frame. The webinar will examine Risk Management 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 training 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 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.

Learning Benefits:
-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.

Webinar outline and time breakdown:

Time*
09:15 AM Log In Period
09:30 AM Introduction
09:40 AM Pharmaceutical Water Systems,
Assay Requirements and Testing,
Design of Water Systems,
System Design and Typical Critical Attribute Performance,
10:30 AM Break
10:40 AM Frequency of Water Sampling, Locations and Test Requirements,
Warning Letters - Water,
Troubleshooting the Water System,
11:30 AM Live Questions & Discussion

*Please note all times are Eastern Time (New York Time)

This live training webinar includes the following for each registered attendee:

  • A copy of the presentation slides
  • A certificate of participation for attendee training records

Who should attend:
The following individuals or disciplines will benefit from attending this Webinar:

  • Facilities
  • Manufacturing
  • Product Development
  • Project Management
  • Quality Assurance
  • Quality Control
  • Regulatory Affairs
  • Regulatory Compliance

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Instructor: Barry A. Friedman Ph.D.

Barry A. Friedman, Ph.D., is a Senior Consultant in the Biotechnology, Regulatory Compliance and Aseptic Processing arena. Dr. Friedman is a frequent seminar speaker in the GMP areas of internal auditing, aseptic processing of sterile drug products, USP microbiology, 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. He is a member of AAMI, ASM, PDA and RAPS. He served as a Captain in the Medical Service Corps, U.S. Army and is the past President of the Capital Area Chapter, PDA... Full Bio>>>

 

 

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Client Testimonials:

"The live webinar was very useful to our team, the content was relevant and the instructor was very knowledgeable" QC Microbiology Supervisor, NJ

"We were very satisfied with the live presentation; we appreciated the speaker staying on to answer all of our questions" QA Director, MA

"Our group enjoyed the live presentation and found the experience much more engaging and worthwhile than any recorded webcasts" Sr Training Manager, CA

"This was my first live training, I found it easy to connect, participate and very useful" Laboratory Analyst, PA

"We had our entire department attend this training program and found it to be very useful, I am very satisfied with the speaker's ability to keep the audience engaged" QC Manager, NY

"Given how recent the content of the webinar was, our team members were very happy with the relevance of the training" VP Clinical Operations, CA

"Is my first time to attend training, I enjoy it very much" Sr Manager, Korea

"Our department found the level of interactivity between the audience and the instructor far beyond that of any other online training that we have attended before. Well done" Director Regulatory Affairs, ON

"Our interest group was spread out over three locations and we were able to participate simultaneously and interact very easily" Lead Compliance Manager, IL

"Well satisfied with the presentation. Our team found the speaker's level of knowledge and his ability to translate that knowledge to our processes very valuable" VP Quality Operations, NC

"We were impressed with the quality of the presentation, and despite our being located in Europe we were able to participate without a hitch" QC Manager, Ireland