Twin Cities Chapter Virtual Event: Managing FDA Inspections Under QMSR – What to Expect

The transition to QMSR isn’t just a paperwork update, it’s a fundamental shift in how the FDA will inspect your quality system. Now that the rule is in effect, let’s talk candidly about what FDA investigators are focusing on under the new harmonized, risk-based framework. We’ll break down the inspection changes that matter most and explore how to align your processes with FDA enforcement priorities and move beyond theory into practical readiness, covering enhanced expectations in complaint handling, supplier transparency, competency verification, and documentation access. Whether you’re adjusting your system or preparing for an upcoming inspection, this session will help you navigate the enforcement mindset of the FDA.

What You Will Learn:

• Post-Implementation Inspection Reality: How we expect FDA investigators to apply the QMSR.
• Updated Complaint & Feedback Management: Leveraging the broader QMSR feedback loop for MDR reporting, risk updates, and preventive action.
• Supplier Oversight in the Transparent Era: Why supplier audit reports are now fair game for FDA review and how to structure agreements that protect you.
• From Training Records to Competency Proof: Practical ways to demonstrate employee capability through risk-based assessment and documented evidence.
• Recordkeeping Under QMSR Scrutiny: What documentation will get more scrutiny under QMSR, from labeling to internal audits.
• Preparing for the FDA’s Enforcement Lens: Shifting from a conformity mindset to a compliance mindset focused on patient safety and regulatory adherence.

Members: $0 | Nonmembers: $20 | Student Members: $0 | Student Nonmembers: $0 (With Promo Code)

Speakers

Jackie Torfin
CEO, Principal Advisor, QLeaR Advisors

Cancellations and Refunds

RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. All cancellation requests must be submitted in writing to support@raps.org. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.

Substitutions

Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email support@raps.org with the event title, name of the original registrant and the contact information for the new attendee.

Proof of Attendance

A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.

Questions