This Pharmaceutical training will discuss Process Analytical Technology (PAT), which represents one of the new approaches used by the pharmaceutical industry to mitigate risk.
Development of PAT is an extension of the FDA Guidance published in August 2002 and titled “Pharmaceutical CGMP for the 21st Century: A Risk-based Approach - A science and risk-based approach to product quality regulation incorporating an integrated quality system approach. We will explore what PAT means and its basic building blocks using the FDA guideline of September 2004. We will also review what it’s intending result and its requirements and conditions are and we will discuss some of the current applications in industry. Once we have developed this base, the presentation will pose questions and attempt to respond to them.
The main questions to be discussed are: 1. How will validation as it is currently conducted be affected? 2. Where and when does PAT start? 3. What are the expected effects of applying PAT on pharmaceutical manufacturing? 4. Who is the operator in this brave new world of PAT? The discussion will strive to respond to those questions and attempt to reassure the audience that the future is bright and that PAT will contribute to its brightness.
Areas Covered in the seminar:
- Process Analytical Technology definition and concept.
- What is PAT’s intended result and how is it reached?
- How to implement PAT in drug manufacturing process and facility? What are the requirements and conditions for implementing PAT?
- Where are the best spots to apply PAT and the pitfall to avoid? Where does PAT start?
- What are the validation implications? Does applying PAT really eliminates the need for validation or just changes its nature?
- Is continuous processing of drugs becoming a reality? How will continuous improvement affect consistency?
- How would you ensure that operators’ training is always up-to-date?
- Where does statistics stop and true process understanding begin.
Who will benefit:
This program is designed to introduce technicians and professionals involved in the manufacture, packaging and storing of drug products to the fundamentals of Process Analytical Technology and it is importance. The discussions would be beneficial to personnel involved in the manufacture, compliance and engineering within biopharmaceutical operations. Professionals and technicians who should attend include:
- Technical Services
- Manufacturing and packaging
- Engineering
- Facilities Services and Maintenance
- Validation
- QA/QC
Instructor Profile:
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 27 years of 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.
