Cost Effective and Convenient - in your office or conference room
Implementing a Risk-based
Approach to GMP Compliance
Conducted by Gamal Amer, Ph.D.
Principal - Premier Compliance Services, Inc.
May 10, 2013
This web seminar will review the background and guidance dealing with science and risk-based GMP compliance and the various approaches suggested by the Food and Drug Administration (FDA), International Conference on Harmonization (ICH), and the American Society for Testing and Materials (ASTM) to mitigate risk and ensure proper compliance is achieved. We will discuss the knowledge, design and control space concepts and their role in mitigating risk and the concept of continuous improvement and how to achieve it.
The topics and documents that will be reviewed in this seminar include:
- FDA Guidance “Pharmaceutical CGMP for the 21st century – A Risk-based Approach” and its implication. Additionally subsequent progress reports issued by the FDA regarding suggested approaches to mitigate risk will be discussed
- Review ICH Q8, Q9, Q10, and ASTM Standard E2500
- How does Quality by Design (QbD) fit within the big picture - ICH Q8 (R1)
- What is meant by Product Life Cycle and Manufacturing Life Cycle
- The jargon and acronym definitions
- Questions and answers with Dr. Amer
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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
GMP130510E - MP3 audio file and handout materials
Implementing a Risk-based Approach to GMP Compliance
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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