Cost Effective and Convenient - in your office or conference room
How to Implement FDA's Latest Guidance on Process Validation
Conducted by Gamal Amer, Ph.D.
Principal - Premier Compliance Services, Inc.
January 25, 2017
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11:00 am EST, 10:00 am CST,
9:00 am MST, 8:00 am PST
The seminar will run for one hour.
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(Note: Washington DC and New York are in the EST)
This seminar will focus on discussing the most recent FDA guidance on Process Validation. The guidance promotes the implementation of a process-product life cycle approach to verification that the process is always in a validated state. The guidance defines three distinct stages to process validation. These are:
Stage 1: Process Design
Stage 2: Process Qualification
Stage 3: Continued Process Verification
This is not a new concept, although the guidance may suggest it is. It was always important in the design and development of the process to consider GMP implications and keep validatability in mind. Process qualification or PQ was always the necessary step confirming that the process is capable of consistently producing a product that meets its predetermined specifications and quality attributes.
As for continuous process verification, this has always been a needed activity and was always accomplished through process and product monitoring. This seminar will review these phases and outlines approaches suggested for continuous process/product improvement.
This seminar will be conducted using GotoMeeting.com and is presented by Gamal Amer, Ph.D., an industry expert on this and other compliance related topics.
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. Dr. Amer's qualifications can be found below.
The log-in information and a handout presentation file (to use as a backup) will be sent to you via email the day before the seminar.
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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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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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