Cost Effective and Convenient - in your office or conference room

GMP, Validation, and Change Control:
Optimizing these Key Elements of an Effective Compliance Program

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

July 9, 2009
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The Federal Food, Drug and Cosmetics Act gives the FDA the authority to ensure that such products are safe for human consumption. The Code of Federal Regulations (CFR) clearly stipulate that manufacturers of healthcare products, namely pharmaceuticals, biologics and medical devices, are to ensure that they are producing quality products and that they build the quality into rather than measuring or testing it into the final product.

To achieve such an objective the industry and the regulators expect that processes to manufacture such products would be validated and that we follow strict change control in our documentation system. This seminar will help you optimize these two important elements of your GMP compliance program.

Specific topics to be covered include:

• Review of the GMP requirements for pharmaceutical manufacturing
• Review of the CFR requirements for validation and process consistency
• Review of ISPE's Baseline Guide on Commissioning and Validation
• Understanding FDA's new proposed Guidance Document on Process Validation
• Current issues in Process Validation - using recent FDA 483 report and Warning Letters observations
• Identifying what constitutes validation and how best to approach it
• How to keep your operation in a validated state by effectively using Change Control
• Questions and answers with Dr. Gamal Amer

This seminar will be conducted on the telephone and is presented by Gamal Amer, Ph.D., an industry expert on this and other compliance related topics.

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. Dr. Amer's qualifications can be found below.
 

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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 MP3 file and handout GMP090709E - MP3 audio file and Handout materials Optimizing GMP, Validation, and Change Control

$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.