30 mins

Root Cause Analysis

ICH E6 – Institutional Review Board / Independent Ethics Committee (IRB/IEC) (Chapter 3) R2

ICH E6 – Introduction and Principles of Good Clinical Practices (GCP) (Sections 1-2) R2

EU Medical Device Regulation (EU MDR) – Chapter 9 – Confidentiality, Data Protection, Funding and Penalties

EU Medical Device Regulation (EU MDR) – Chapter 10 – Final Provisions

EU Medical Device Regulation (EU MDR) – Chapter 8 – Cooperation Between Member States

The Lifecycle of a Change Control Program – Examples of Change Controls, Documents & Recording Completed Changes

Commissioning Qualification and Validation the Concept of CQV – Part 2

Commissioning Qualification and Validation the Concept of CQV – Part 1

Change Control: Regulations and Guidelines