GMP Training Systems

New Web Seminar

Cost Effective – Time Effective – In your Conference Room or Office

Validation Protocol Execution
and Addressing Deviations

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

May 9, 2008

This seminar presents an overview of a proposed methodology to execute validation protocols.  We will review the requirements to be fulfilled to facilitate protocol execution. The seminar will define who is to execute the protocols, the need for calibrated instruments and validated analytical methods. The discussion will also define validation protocol deviations and how to address them.  This will be accomplished by proposing a systematic approach to addressing the deviations and provide a logic tree, which when followed will result in resolving such deviations. Finally we will review how to prepare a final report summarizing protocol execution, which should be easily approved. This discussion will provide the validation professional with ways to expedite the validation effort and avoid protocol execution deviations related delays during the execution of the validation program.

A new facility for drug processing has been built; a Validation master Plan (VMP) was developed and approved. All necessary documents associated with the process and facility have been collected and the proper protocols have been developed and approved. Protocol execution begins once the equipment is installed and becomes operational. The personnel required is defined and begins the execution. They need the proper instruments and the appropriate laboratory support. Invariably deviations and non-conformances will be encountered. These deviations must be addressed and resolved prior to completing the validation effort and summarizing the results. The final step of summarizing the result and confirming the process is validated and acceptable for use is the culmination of this effort and hence a critical step in the effort.

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.

Validation Protocol Execution and Addressing Deviations

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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 web location to download the handout materials.

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Get the CD and handout GMP080509E - CD and Handout materials Validation Protocol Execution and Addressing Deviations CD price includes all HANDOUT MATERIALS and audio CD. CD will be shipped three weeks after the seminar

$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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