Cost Effective and Convenient - in your office or conference room
Validation of Water Systems
in the Pharmaceutical Industry
Conducted by Gamal Amer, Ph.D.
Principal - Premier Compliance Services, Inc.
April 11, 2014
Water production systems represent one of the most critical utilities in the pharmaceutical industry. These systems are the key to compounding product, manufacturing ingredients, cleaning of the equipment and manufacturing facilities for drug production operations. This presentation will discuss the characteristics of water systems and how to ensure the system is properly validated. The seminar will focus on applying the principles outlined in the recently proposed FDA guidance on Process Validation.
We will address the activities which should take place during the design and development of the water system for the biopharmaceutical manufacturing operation as the first step in validating the system. Then we will address the appropriate activities which should take place during the implementation and qualification stage. The discussion will consider verification activities as well as Performance Qualification (PQ) and how to develop the appropriate protocols, design the correct tests, and define the proper acceptance criteria to ensure the system is qualified. We will then consider the protocol execution phase and how to ensure that the system is fit for the intended use. Finally, we will review the appropriate activities to continually verify and ensure the system remains in a validated state through conducting environmental monitoring and applying change control.
By participating in this presentation you will learn:
- What the applicable regulatory requirements are
- What are the appropriate design steps and the resulting documentation
- How to qualify the water system and what the protocols would look like
- How to define the acceptance criteria
- What constitutes continued verification and how to maintain the validated state
- Monitoring, statistical trending, and review of critical data to verify proper control of the required water properties
- Using the data from monitoring to assess the effect of seasonal variations
- Using data gathered during the continued process verification to improve and/or optimize the systems
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All registrations include handout materials. Once you’re registered, you will receive via e-mail (the e-mail address you provide in your registration) the presentation handout materials the day before the seminar.
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Get the MP3 file and handout
GMP140411E - MP3 audio file and Handout materials
Validation of Water Systems
Gamal Amer, Ph.D.
Gamal Amer, Ph. D. is Principal at Premier Compliance Services, Inc.; Management Consultants for compliance and manufacturing operations performance in the life sciences industry. He holds a Ph. D. in Chemical Engineering and has over two decades experience in the Pharmaceutical and related industries. He has held positions of increased responsibility with leading pharmaceutical, consumer product and engineering consulting firms over the years. His experience includes comprehensive process design in bulk pharmaceutical manufacturing, biotechnology manufacturing, pharmaceutical solid dosage manufacturing and containment of potent and radioactive therapeutics. He is also experienced with facility development for therapeutic products operations.
Dr. Amer is a recognized expert in GMP compliance and validation. He has consulted for many of the leading pharmaceutical, biotechnology and medical device manufacturers. He has lectured extensively in the US, Europe, Asia and the Middle East, taught many courses, and authored many papers which were published in peer reviewed publication. He is a member of ISPE, PDA, ACS and AIChE.
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