Intermediate

ICH Q9 – Quality Risk Management

Human Error Prevention

Good Distribution Practices: Operational Principles

Technical Writing in a Regulated or Accredited Environment

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

EU Medical Device Regulation (EU MDR) – Chapter 7 – Post Market Surveillance, Vigilance and Market Surveillance

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

MDSAP Country Specific Requirements (Japan)