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Unraveling the Mysteries of Process Validation:
ASTM E2500 Consensus Standard and
FDA's Guidance on Process Validation Explained
Conducted by Gamal Amer, Ph.D.
Principal - Premier Compliance Services, Inc.
February 7, 2014
This seminar will focus on providing an overview of the contents of the ASTM E2500 Consensus Standard and relate its approach to process qualification and to the contents of FDA's NEW Guidance on Process Validation. The standard is changing the way qualification is conducted and although it was issued in advance of the FDA Guidance it is in complete agreement with the thinking outlined in the Guidance.
The main impetus for developing the standard is to reduce the cost of validation and simplify the effort for industry. This new approach achieves such an objective through reducing the effort from the current established commissioning, qualification and validation approach, to a simple verification followed by qualification.
The E2500 Consensus Standard is indeed in line with the FDA guidance’s Stage 1 (Process Design) and Stage 2 (Process Qualification) by suggesting 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). In addition, the ASTM E2500 Standard indicates that continuous improvement of the process is an important component of process verification which is the basis of Stage 3 (Continued Process Verification) in the new FDA Guidance.
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GMP140207E - audio recording and handout materials
Unraveling the Mysteries of Process Validation
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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