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ASTM E2500 Consensus Standard: An Overview of a New Approach to Validation

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

June 11, 2010

This seminar will focus on providing an overview of the contents of the ASTM E2500 consensus standard. This important standard was finalized and issued in the summer of 2007. Because this is a consensus standard, all governmental agencies are required by law to accept its premise and abide by its requirements. So unless an agency chooses to challenge it in court, the standard will be followed. Both industry and the regulators are still reviewing it and assessing its potential impact.

The main impetus for developing the standard was to reduce the cost of validation and simplify the effort for industry. The standard achieves such an objective through reducing the effort from the current established commissioning, qualification and validation approach, to verification followed by validation.

The standard further suggests that verification of equipment and systems’ suitability for the intended use can be achieved through an overall quality approach, which starts at the conceptual phase of the project and continues through start-up and operation. This includes a science and risk- based evaluation to determine the extent of the effort while utilizing information developed by the suppliers all under the guidance of Subject Matter Experts (SMEs).

By participating in this presentation you will learn:

• The details of this new standard and how to apply them
• What is meant by Verification of suitability for intended use
• How to use a science- and risk-based approach to ensure the proper verification is conducted
• The importance of URS (Users Requirements Specifications), GEP (Good Engineering Practice), QbD (Quality by Design), and SMEs in support of the validation effort
• The differences and similarity with the current approach to validation
• What’s in store for the immediate future

 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.

Part I - Understanding the new Standard

• The details of this new standard and how to apply them
• What is meant by Verification of suitability for intended use
• How to use a science- and risk-based approach to ensure the proper verification is conducted
• The importance of URS (Users Requirements Specifications), GEP (Good Engineering Practice), QbD (Quality by Design), and SMEs in support of the validation effort
• The differences and similarity with the current approach to validation
• What’s in store for the immediate future

Part II - Questions and Answers

• Dr. Amer will field your questions live on the phone. You will hear all questions and answers from all participants of this seminar.

 Register now!

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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 GMP100611E - MP3 audio file and Handout materials ASTM E2500 Consensus Standard	$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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