LTR Monthly Webinar: February 2024
This month, we talk with industry veteran Rick Rios about the process-based auditing approach in Medical Device Single Audit Program (MDSAP) and how it could help prepare medical device manufacturers to comply with FDA’s Quality Management System Regulation (QMSR).
More importantly, we also discuss how QA/RA professionals, especially those who are new to MedTech, can continue to advance their careers in our rapidly changing industry.
Watch the full episode (approximately 65 minutes) or jump to the topic of interest using the timestamps below:
Chapters
0:01:00 Introducing Risk Rios
0:04:23 Process approach to quality systems
0:06:10 Why FDA is moving to QMSR
0:08:43 MDSAP and need for global harmonization
0:14:00 Auditing approach moving to process-based from element-based
0:20:06 How to evaluate process effectiveness in audits
0:22:10 Challenges in the practice of process-based approach
0:24:25 Measures of efficiency and effectiveness
0:27:42 QMSR requires a shift in mindset to purpose and effectiveness
0:28:57 Challenges ahead in practicing a process approach
0:31:20 A good way to structure your SOPs
0:33:02 Common gaps in risk management
0:38:00 How MDSAP auditing model helps identify and fix gaps in risk management
0:41:52 Difference between MDSAP and ISO 13485 certification
0:43:31 Getting ready for QMSR
0:45:25 Career trajectory, lessons learned, and career tips
1:00:00Closing comments
About Rick Rios
Rick Rios started his career in the defense industry working as a systems engineer in nuclear programs. Inspired by the Total Quality Management movement, he moved into a Quality and Regulatory role, and later worked in automotive and aerospace industries as an independent auditor. He has been active in the medical device industry as an independent auditor over nearly 15 years. He has successfully developed, integrated, implemented and audited quality systems based on ISO 13485, 21CFR820, MDSAP, EUMDR, DOE QC-1, NQA-1, ISO 9001, ISO 17025, NCSL Z540, and Baldrige Performance Excellence Program.
Disclaimer
Information and insights presented in this podcast are for educational purposes only. Views expressed by all speakers are their own and do not reflect those of their respective organizations.
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