This web-seminar presents an overview of validation and change control as they pertain to pharmaceuticals manufacturing. Dr. Amer will review the general validation approach, define what is meant by a validated state, and identify the need for having a change control system and procedure in place. He will then proceed to define what a change control system entails and propose an outline of a robust change control procedure. The concept of validation life-cycle will also be introduced and its meaning discussed at length. The importance of change control in maintaining the validated state and closing the validation cycle will be discussed.
Managing changes in pharmaceuticals manufacturing through implementing a change control procedure is a regulatory requirement. Manufacturers of drug products are required to maintain the operations in a validated state and to have a change control. This web-seminar is aimed at introducing the concept of a validated state and managing change within the validation life cycle. Dr. Amer will draw on his vast experience in the pharmaceutical industry to explain the concepts and provide many real life examples to support these concepts.
By attending this presentation you will learn:
- What is meant by validation and its confirmatory nature
- How is validation conducted
- The validated states and the importance of maintaining it
- The Validation Life Cycle
- The types of change and their potential impact on the validated state
- What a change control system entails and its importance
- What a robust change control system and procedure may look like and entail
FEE:
Instructor: Gamal Amer, Ph. D.
Dr. Amer 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 30 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.
