Learning Paths
Core
- The Fundamentals of Quality Management Systems – Pharma
- The Fundamentals of GxP in a Regulated Environment
- The Fundamentals of Good Manufacturing Practices
- The Fundamentals of Data Integrity
- The Fundamentals of Good Pharmacovigilance Practices (GVP)
Build
- Supplier Quality Management
- How to Perform Supplier Qualification
- Customer Complaint Handling
- CAPA and Effectiveness Checks
- General Inspection Readiness
- How to Write Effective Standard Operating Procedures (SOPs)
- ICH Q9 – Quality Risk Management
- Recalls and Consent Decrees
- Regulatory Submissions
- Change Control: Core Concepts
- Batch/Product Release
Refresh
- GxP Hot Topics: Cybersecurity Refresher Course
- Good Documentation Practice Refresher Course
- Data Integrity Refresher Course
- Good Manufacturing Practice 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
Good Pharmacovigilance Practices (GVP)
The Fundamentals of Good Pharmacovigilance Practices (GVP)
20 mins
Basic
Good Documentation Practices (GDocP)
How to Write Effective Standard Operating Procedures (SOPs)
60 mins
Basic
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)
ICH Q9 – Quality Risk Management
25 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