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Validation Protocol Development and Acceptance Criteria

Conducted by Gamal Amer, Ph.D.
Principal - Premier Compliance Services, Inc.

May 7, 2010

The validation protocol is the road map which guides the qualification effort for a given piece of equipment or system. It not only describes in detail what experiments would be conducted but also serves as a repository of the data collected during the execution of the document. The validation protocol also defines the objective results to be met by the testing; these are usually referred to as predetermined acceptance criteria. This seminar will show you how to define the acceptance criteria and develop a successful protocol.

This seminar begins by describing the industry standard for using protocols to complete the validation effort. It then proceeds by defining what each protocol’s objective is. Next is defining the contents of a typical validation protocol and real life examples to illustrate the points being made. We will discuss protocols for utility systems, process equipment and cleaning validation.

We will provide ideas as to what should be included into the various sections of the protocol. Finally, we will discuss steps to be taken to ensure the protocol is developed and approved easily and on a timely basis. These suggested steps would result in increasing the probability that the protocols will be developed and executed with a minimum number of rewrites and deviations.

In this unique web seminar format, lasting just one hour, you will be able to follow along with a PowerPoint presentation, ask questions, and interact with Dr. Amer. An outline of this seminar and Dr. Amer’s qualifications can be found below.

The handout presentation file will be sent to you via email the day before the seminar.

Validation Protocol Development and Acceptance Criteria

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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 GMP100507E - MP3 audio file and Handout materials Validation Protocol Development	$397.00

Instructor

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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