UNANNOUNCED AUDITS: AN OVERVIEW OF THE COMMISSION RECOMMENDATION, STRATEGIES FOR PREPARING IN ADVANCE, AND A NOTIFIED BODY’S EXPERIENCE TO DATE
- The Requirements for Unannounced Audits
- Notified Body Implementation
- Assessment Model
- Audit Conduct and Timelines
- What to Expect on the Day
- Manufacturer Readiness and Responsibilities
- Budgeting, Preparing and Practicing for Unannounced Visits
- Subcontractors and Supplier Considerations
- A Notified Body’s Experience to Date
Speaker:
Vicky Medley
Head of QMS – Medical Devices
BSI
Paul Sim
Regulatory Affairs Manager – Medical Devices
BSI
Contact:
Brooke Akins | Division Director, Life Science Programs
+1 (312) 224-1693
bakins@q1productions.com
CONTACT US
Q1 Productions
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T: +1 (312) 822-8100
hello@q1productions.com