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ISO 13485/GMP Workshop
Seminar for ISO 13485:2003 and FDA 21 CFR Part 820 ISO 13485:2003 is a standard based on ISO 9001 that is specific to medical devices. Many medical device companies are utilizing it as a platform to build their business management systems because of its benefits. This standard is not adopted by the Food and Drug Administration (FDA) but the FDA participated in writing ISO 13485:2003 to make sure their requirements and ISO 13485:2003 are aligned. Therefore, if a company meets the requirements of ISO 13485:2003, they should easily be able to meet the FDA Quality System Requirements (QSR). FDA 21 CFR Part 820, also known as the Quality System Regulation, outlines Current Good Manufacturing Practice (CGMP) regulations. These govern the methods used in companies for the control of design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use. These requirements are meant to ensure that medical devices are safe and effective. This seminar will include an explanation of ISO 13485:2003 and FDA 21 CFR Part 820. The following topics will be covered: - Understand each element of ISO 13485:2003 - Differences and additions between this standard and ISO 9001 - Understand each section of FDA 21 CFR Part 820 - FDA registration - FDA audits - Product releases using 510k and Pre Market Approval mechanism The instructor is David Potty who is a Senior Member of ASQ and has the following certifications from ASQ, CQMgr., CQE, CQA, and CBA. He is also a Six Sigma Black Belt. David has worked for many medical devices companies helping them receive registration to ISO 13485 as well as dealing with the FDA. |
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