Learning Paths
Core
- The Fundamentals of Good Clinical Practice (ICH E6 R2)
- The Fundamentals of Good Pharmacovigilance Practices (GVP)
- ELM-224 – The GxP Road Map: From Pipeline to Patient
- The Fundamentals of Quality Management Systems – Pharma
- The Fundamentals of Data Integrity
Build
- How to Perform Supplier Qualification
- Supplier Quality Management
- Customer Complaint Handling
- CAPA and Effectiveness Checks
- General Inspection Readiness
- Writing Effective Standard Operating Procedures
- ICH Q9 – Quality Risk Management
- Recalls and Consent Decrees
- Regulatory Submissions
- Change Control: Core Concepts
- Batch/Product Release
- ICH E6 – Sponsor (Chapter 5) (R2)
- GVP PSUR (Periodic Safety Update Reports)
Refresh
- Good Clinical Practice 2024 Refresher Course
- GxP Hot Topics: Cybersecurity 2024 Refresher Course
- Good Documentation Practice 2024 Refresher Course
- Data Integrity 2024 Refresher Course
- Aligning Success KPIs and Quality Culture
- Data Integrity Applies to Everyone in the Organization – ALCOA+ [Video]
- How Self-Inspection Leads to Continuous Improvement
- Ignoring Issues and the Repercussions That Can Follow
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)
ICH Q9 – Quality Risk Management
25 mins
Intermediate
Good Pharmacovigilance Practices (GVP)
GVP PSUR (Periodic Safety Update Reports)
15 mins
Intermediate
Data Integrity (ALCOA)
Data Integrity Applies to Everyone in the Organization – ALCOA+ [Video]
1 min
FDA Inspection Readiness (GMP Auditing)
How Self-Inspection Leads to Continuous Improvement
3 mins
Basic