FDA has been utilizing information based on inspections conducted by third parties and other regulators in different circumstances pursuant to MDUFMA 2002. This webinar is intended to help you get familiar with FDA’s implementation of statutory requirements for setting risk-based FDA inspectional priorities. In particular, it deals with FDA’s accepting voluntary ISO 13485 audit report submission requirements. This webinar is further intended to better understand FDA’s medical device quality compliance program. As FDA is trying to leverage audits conducted by other regulators other than Health Canada and their accredited third parties in an effort to help the FDA set risk-based inspectional priorities, it is imperative we industry understand quality management system requirements implemented under ISO 13485 and ISO 13485 audit reports so that we can
participate in the FDA’s voluntary audit report submission program to save our time, efforts and various resources and to further assist the FDA’s efforts setting the risk-based inspectional program.
This webinar will help you greatly increase your awareness and familiarity with the FDA’s medical device quality compliance program, ISO 13485 requirements and FDA’s voluntary ISO 13485 audit report submission program
At the end of this webinar, you will develop your insight on what is best for your business under limited resources and circumstances.
Objectives of the Presentation:
- To better understand the FDA’s implementation of the statutory requirements for setting risk-based FDA inspectional priorities
- To understand ISO 13485 requirements, auditing, and voluntary ISO 13485 auditing report submission to the FDA
- To better understand the FDA’s medical device quality compliance program
- Statutes and Regulations
- Quality Systems and Subsystems in ISO 13485
- Quality Systems and Subsystems under 21 CFR Part 820
- Comparative Overview of both ISO 13485 and 21 CFR Part 820
- FDA and ISO 13485
- ISO 13485 Auditing
- ISO 13485 Audit Reports
- FDA Action Based on Audit Reports
- Good Practices: Speaker’s Suggestions and Recommendations
Who will benefit:
- Quality Professionals
- Compliance Staff and Officers
- Regulatory Affairs
- Clinical Affairs
- Anyone Interested in the Topic for ISO 13485 or 21 CFR Part 820
Why you should attend:
- To better understand ISO 13485, FDA’s medical device quality compliance program and FDA’s voluntary ISO 13485 audit report program.
Dr. Lim is President and Principal of Regulatory Doctor (http://www.regulatorydoctor.com). Dr. Lim frequently presents global regulatory and quality compliance topics including 510(k)s in various forums and meetings. Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past seven years. Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009. Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author. Dr. Lim leads and directs all research projects including, but not limited to, pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor. Currently Dr. Lim is an adjunct professor in regulatory affairs at Northeastern University in Boston, MA.
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