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Master Planning for Validation:
Complying with FDA's Latest Guidance
Conducted by Gamal Amer, Ph.D.
Principal - Premier Compliance Services, Inc.
September 20, 2013
FDA released a new Guidance Document on Process Validation in January 2011. The changes in this NEW guidance impacts the development of a Validation Master Plan. This web seminar will cover what you now need to do to develop a Validation Master Plan that complies with FDA's newest requirements.
A Validation Master Plan (VMP) is a scope document aimed at outlining the approach of validating the healthcare product production facility and process. Its intent is to define and enumerate critical systems to be validated and outlines the approach to validate such systems. The VMP’s main objective is to outline in sufficient detail the approach to be taken by an organization to develop documented evidence that the process used to manufacture the Pharmaceutical, Biopharmaceutical or device, will result in a product which meets its predetermined quality attributes. This presentation will discuss a pragmatic way of getting it done.
This web seminar presents a recommended validation approach and will define the contents of a typical validation master plan. This seminar will also present real life examples to illustrate the points being made. Additionally, the presentation will provide ideas as to what should be included into the various sections of the VMP. Finally, we will discuss steps to be taken to ensure the VMP is developed on a timely basis and earn the buy-in and commitment from all stakeholders within the organization. Following this approach would result in increasing the probability that the VMP will be approved and successfully implemented.
Validation Master Planning: Complying with FDA's NEW Guidance
- Defining validation
- Defining how validation is conducted
- Determining the need for a validation master plan
- The basic contents of a master plan
- Identifying what each section should contain
- Identifying which systems require validation
- How to schedule validation activities
- What it takes to develop an effective Master Plan
- How to get your Master Plan approved
- Dr. Amer will field your questions live on the phone
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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 Audio recording and presentation file
GMP130920E - audio recording and handout materials
Master Planning for 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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