The hearts of all quality professionals get moving quicker at the mention of a notified body audit or regulatory (FDA) inspection. We all know this is part of being in the medical device industry, so why be stressed about this regular occurrence?
Often, we treat this as something that is done TO us, but being audited is NOT a passive activity. If you understand the need for active participation in the audit process, you will be ahead of the game in avoiding a catastrophic outcome that can come with Major nonconformances or regulatory observations (483’s). We can help you avoid that unnecessary stress and experience better outcomes. This session is generally aimed at small to medium-sized organizations, but the principles apply to large companies as well.
In this focused, fast-paced half day session, we will cover:
- Audit/inspection Readiness
- Audit/inspection Management
- Do’s and Don’ts during the audit/inspection
- Audit/inspection Follow-up
REGISTER HERE: https://events.eply.com/AuditReadinessManagement3362008
Certificates of completion will be issued - 0.4 ASQ RUs or 0.4 CEUs
Mark Swanson (ASQ CMQ/OE, CQE, CBA) is the President and lead consultant of Quality and Regulatory Expert Partners, LLC; a partnership focused on helping small to mid-sized companies have the same regulatory and quality systems knowledge as the large medical device companies. Mark has more than 20 years of experience in the medical device industry including all roles in quality. He is a senior member of ASQ, RAPS member and a corporate AAMI member (serving on several AAMI committees).
Mark has spent the last several years as an active member of ISO Technical Committee 210 (ISO TC210), Working Group 1 (WG1) working on the revision of ISO 13485 that was published on March 1, 2016, was the project co-lead for the guidebook on ISO 13485 and Working Group 6 (WG6) on post-market surveillance (ISO TR 20416). He has also participated with ISO TC176, WG24 on ISO 9000/9001:2015 and in the AAMI group responsible for TIR 102, to formally compare ISO 13485 to the US FDA Quality System Regulation. To add to this, Mark also participated in the US TAG for risk management (ISO 14971) and the workshop that created IWA 31 (agreement on the application of risk management in standards). In this work he leads the discussions regarding the impact of changes in the ISO quality management system standards, the integration of various standards and how to effectively integrate these various international standards and other regulations into a single management system.