The FDA’s Quality System regulation constitutes the same “umbrella” approach to the CGMP regulation that was the base of the original CGMP regulation. The QS regulation applies to many different types of devices, and does not elaborate how a specific device needs to be produced by a manufacturer. Instead, the regulation prescribes a framework that every manufacturer must follow and requires that manufacturers create and follow procedures and fill in the details that are suitable to a given device according to the current state-of-the-art manufacturing for that specific device, and meet the requirements of 21 CFR 820.
In this session, expert speaker Joy McElroy will discuss the history of the QS regulation and its introduction. Upon attending this session, you will understand the basics of the Quality System regulation, 21 CFR 820 and how it relates to ISO 9000 13485. This session will cover design control guidance and the FDA’s advice on human factor and medical devices. Joy will also discuss GMP exemptions for medical devices.
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Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.
- Casper E. Uldriks
Joy McElroy made her debut in the pharmaceutical industry in 1992 at Pharmacia & Upjohn performing environmental monitoring and sterility testing after earning a degree in zoology at North Carolina State University. She moved into a supervisory role at Abbott Laboratories where she oversaw their Quality Control Lab. In 1998 Joy moved to Wyeth Lederle and worked in Quality Assurance, performing GMP Compliance audits, batch record reviews, and...
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