Discussion: View Thread

The new QMSR rules are here, and they're already reshaping FDA inspections. Let's talk about what FDA investigators are looking for under the harmonized, risk-based framework, and how you can stay ahead of the curve. Join us for a conversation on real-world inspection readiness, from complaint handling to supplier transparency, and learn how to turn compliance into confidence.
𝐄𝐯𝐞𝐧𝐭 𝐎𝐯𝐞𝐫𝐯𝐢𝐞𝐰:
𝐃𝐚𝐭𝐞: February 24, 2026
𝐓𝐢𝐦𝐞: 12:00 – 1:00 PM (CST)
𝐋𝐨𝐜𝐚𝐭𝐢𝐨𝐧: Virtual
𝐅𝐞𝐞𝐬:
• RAPS Members: $0
• Non-RAPS Members: $20
• Students: $0 (Request Promo Code)
𝐀𝐮𝐝𝐢𝐞𝐧𝐜𝐞: Quality Managers, Regulatory Affairs Professionals, Compliance Officers, and Medical Device Manufacturers
𝐖𝐡𝐚𝐭 𝐘𝐨𝐮 𝐖𝐢𝐥𝐥 𝐋𝐞𝐚𝐫𝐧:
• 𝐐𝐌𝐒𝐑 𝐈𝐧𝐬𝐩𝐞𝐜𝐭𝐢𝐨𝐧 𝐑𝐞𝐚𝐥𝐢𝐭𝐲: FDA Enforcement Expectations.
• 𝐂𝐨𝐦𝐩𝐥𝐚𝐢𝐧𝐭 & 𝐅𝐞𝐞𝐝𝐛𝐚𝐜𝐤: Leveraging the QMSR loop for MDR reporting, risk updates, and preventive action.
• 𝐒u𝐩𝐩𝐥𝐢𝐞𝐫 𝐎𝐯𝐞𝐫𝐬𝐢𝐠𝐡𝐭: Managing the new visibility of supplier audit reports and structuring protective agreements.
• 𝐏𝐫𝐨𝐯𝐢𝐧𝐠 𝐂𝐨𝐦𝐩𝐞𝐭𝐞𝐧𝐜𝐲: Moving beyond training records to demonstrate employee capability through risk-based evidence.
•𝐑𝐞𝐜𝐨𝐫𝐝𝐤𝐞𝐞𝐩𝐢𝐧𝐠 𝐒𝐜𝐫𝐮𝐭𝐢𝐧𝐲: Identifying high-priority documentation under QMSR, from labeling to internal audits.
• 𝐄𝐧𝐟𝐨𝐫𝐜𝐞𝐦𝐞𝐧𝐭 𝐑𝐞𝐚𝐝𝐢𝐧𝐞𝐬𝐬: Shifting from simple conformity to a compliance mindset.
𝐖𝐡𝐲 𝐀𝐭𝐭𝐞𝐧𝐝:
With QMSR now enforced, your inspection readiness must reflect the new regulatory reality. If you're preparing for an inspection or just want to understand where the FDA's focus will be in 2026, this is your chance to talk it through. We'll leave you with actionable insights and a clearer path to inspection-ready confidence.
𝐒𝐩𝐞𝐚𝐤𝐞𝐫'𝐬 𝐁𝐢𝐨
Jacqueline Torfin is the CEO and Principal Advisor of QLeaR Advisors, where she empowers MedTech and Biotech companies to conquer quality and regulatory challenges. With over 36 years of experience, she translates a complex web of global regulations into actionable strategies for start-ups and emerging growth companies.
Her distinguished corporate career includes executive global roles in quality, regulatory, and clinical affairs for major firms like Beckman Coulter, PDL BioPharma, 3M/Arizant, Heraeus, and NAMSA, where she led quality, compliance, data protection, and program management offices.
A dedicated advocate for the profession, Ms. Torfin also serves as adjunct faculty at St. Cloud State University, where she helped design and now teaches in the Master's program for Medical Technology Quality and Regulatory Affairs.
She is a certified Quality Auditor (ASQ) and an ISO 9001/13485 and EU MDR certified auditor for Europe. Ms. Torfin holds a B.S. in Medical Technology from the University of Minnesota and an M.A. in Leadership from Augsburg College.

Hi Georgiann,

I just registered for this webinar and the email with meeting information says the event is on February 5...even though the information on the sign up page agreed with this notice (event on February 24).  Maybe needs an update somewhere in the system!

Nancy

The new QMSR rules are here, and they're already reshaping FDA inspections. Let's talk about what FDA investigators are looking for under the harmonized, risk-based framework, and how you can stay ahead of the curve. Join us for a conversation on real-world inspection readiness, from complaint handling to supplier transparency, and learn how to turn compliance into confidence.
𝐄𝐯𝐞𝐧𝐭 𝐎𝐯𝐞𝐫𝐯𝐢𝐞𝐰:
𝐃𝐚𝐭𝐞: February 24, 2026
𝐓𝐢𝐦𝐞: 12:00 – 1:00 PM (CST)
𝐋𝐨𝐜𝐚𝐭𝐢𝐨𝐧: Virtual
𝐅𝐞𝐞𝐬:
• RAPS Members: $0
• Non-RAPS Members: $20
• Students: $0 (Request Promo Code)
𝐀𝐮𝐝𝐢𝐞𝐧𝐜𝐞: Quality Managers, Regulatory Affairs Professionals, Compliance Officers, and Medical Device Manufacturers
𝐖𝐡𝐚𝐭 𝐘𝐨𝐮 𝐖𝐢𝐥𝐥 𝐋𝐞𝐚𝐫𝐧:
• 𝐐𝐌𝐒𝐑 𝐈𝐧𝐬𝐩𝐞𝐜𝐭𝐢𝐨𝐧 𝐑𝐞𝐚𝐥𝐢𝐭𝐲: FDA Enforcement Expectations.
• 𝐂𝐨𝐦𝐩𝐥𝐚𝐢𝐧𝐭 & 𝐅𝐞𝐞𝐝𝐛𝐚𝐜𝐤: Leveraging the QMSR loop for MDR reporting, risk updates, and preventive action.
• 𝐒u𝐩𝐩𝐥𝐢𝐞𝐫 𝐎𝐯𝐞𝐫𝐬𝐢𝐠𝐡𝐭: Managing the new visibility of supplier audit reports and structuring protective agreements.
• 𝐏𝐫𝐨𝐯𝐢𝐧𝐠 𝐂𝐨𝐦𝐩𝐞𝐭𝐞𝐧𝐜𝐲: Moving beyond training records to demonstrate employee capability through risk-based evidence.
•𝐑𝐞𝐜𝐨𝐫𝐝𝐤𝐞𝐞𝐩𝐢𝐧𝐠 𝐒𝐜𝐫𝐮𝐭𝐢𝐧𝐲: Identifying high-priority documentation under QMSR, from labeling to internal audits.
• 𝐄𝐧𝐟𝐨𝐫𝐜𝐞𝐦𝐞𝐧𝐭 𝐑𝐞𝐚𝐝𝐢𝐧𝐞𝐬𝐬: Shifting from simple conformity to a compliance mindset.
𝐖𝐡𝐲 𝐀𝐭𝐭𝐞𝐧𝐝:
With QMSR now enforced, your inspection readiness must reflect the new regulatory reality. If you're preparing for an inspection or just want to understand where the FDA's focus will be in 2026, this is your chance to talk it through. We'll leave you with actionable insights and a clearer path to inspection-ready confidence.
𝐒𝐩𝐞𝐚𝐤𝐞𝐫'𝐬 𝐁𝐢𝐨
Jacqueline Torfin is the CEO and Principal Advisor of QLeaR Advisors, where she empowers MedTech and Biotech companies to conquer quality and regulatory challenges. With over 36 years of experience, she translates a complex web of global regulations into actionable strategies for start-ups and emerging growth companies.
Her distinguished corporate career includes executive global roles in quality, regulatory, and clinical affairs for major firms like Beckman Coulter, PDL BioPharma, 3M/Arizant, Heraeus, and NAMSA, where she led quality, compliance, data protection, and program management offices.
A dedicated advocate for the profession, Ms. Torfin also serves as adjunct faculty at St. Cloud State University, where she helped design and now teaches in the Master's program for Medical Technology Quality and Regulatory Affairs.
She is a certified Quality Auditor (ASQ) and an ISO 9001/13485 and EU MDR certified auditor for Europe. Ms. Torfin holds a B.S. in Medical Technology from the University of Minnesota and an M.A. in Leadership from Augsburg College.