Cost Effective and Convenient - in your office or conference room
Understanding and Implementing FDA's
New Draft Guidance on Quality Agreements
Conducted by Gamal Amer, Ph.D.
Principal - Premier Compliance Services, Inc.
December 5, 2013
This web seminar will review the recently proposed FDA Draft Guidance on Quality Agreements. Quality Agreements, which are developed to manage and facilitate the relationship between owners and contractors, and are intended to define all the expectations for both parties when it comes to complying with GMP requirements. Although not a GMP requirement, the FDA expects such a document will exist and would have specific content. This seminar will review such expectations and will discuss the expected content. We will also define what a quality agreement looks like, what its content would be, where the responsibilities lie and how to ensure that the proper content is included in the document.
By attending you will learn:
- What is meant by Quality Agreements
- What are the FDA’s expectation in regards to Quality Agreements
- What is meant by the title owner, contractor, adulterated drug, and the term manufacturing within the guidance
- Where does the guidance apply and where it does not
- What are the responsibilities of the owner and the contractor as it relates to the manufacture of drug products
- What are the key components of a quality agreement
- How to prepare a good quality agreement
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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
GMP131206E - audio recording and handout materials
Implementing Guidance on Quality Agreements
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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