Yes

Change Control – Approver

General Principles of Good Clinical Practices (ICH E6 R3)

EudraLex – Volume 4 Annex 1: Environmental Monitoring and Quality Control

EudraLex – Volume 4 Annex 1: Sterile Processing and Technologies

Change Control – Owners

Protecting Proprietary Information

EudraLex – Volume 4 Annex 1: Pharmaceutical Quality Systems and Contamination Control Strategies

ICH E8 Section 7 – Considerations in Identifying Critical to Quality Factors

The Fundamentals of Good Clinical Practice (ICH E6 R3)

Alcohol and Marijuana Use