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Manage & Comply:- FDA's Quality Agreements
Quality agreements are an integral part of outsourced GMP manufacturing and testing. They define the framework for quality expectations between you and your vendors and the responsibilities necessary to demonstrate drug quality, safety, and efficacy. FDA issued dozens of 483 observations relating to topics governed by the quality agreement system in the past. Furthermore, FDA finalized the "Contract Manufacturing Arrangements for Drugs: Quality Agreements Guidance for Industry" document.
The 90-minutes webinar will be conducted by Joy McElroy, Upon earning a degree in Zoology at North Carolina State University, Joy began working in the pharmaceutical industry in 1992 at Pharmacia & Upjohn performing Environmental Monitoring and Sterility Testing. Joy work allowed her to move into a supervisory role at Abbott Laboratories where she oversaw the Quality Control Lab. In 1998 she moved to Wyeth Lederle and worked in Quality Assurance, performing GMP Compliance audits, batch record reviews, holding annual GMP training for new employees, and writing audit report, and SOPs.
Webinar attendees will learn:
• Regulatory requirements for supplier qualification
• Responsibilities of manufactures and suppliers
• The who and what of a good Quality Agreement
• What a Quality Agreement is - and is not
• What is meant by the title owner, contractor, adulterated drug, and the term
manufacturing within the guidance?
• Responsibilities of the owner vs. contract facility
• GMP responsibilities
• Best practices for a good quality agreement
• A comparison of the new guidelines from the FDA and the EU
• Documentation requirements and audit trails
To register for the webinar, visithttps://www.edupliance.com/
Edupliance is an online information provider which offers webinars (Live and On-
Demand), DVD's and downloadable resources that cover concurrent topics pertaining to various industries. With an expert panel of guest speakers, Edupliance brings state-of-the-
For more information, visit