Learning Paths
Core
- The Fundamentals of Good Manufacturing Practices
- The Fundamentals of Data Integrity
- The Fundamentals of Good Documentation Practice
- Process Validation: Core Concepts
Build
- The Devastating Effects of Not Following GMP
- Batch/Product Release
- Recalls and Consent Decrees
- General Inspection Readiness
- CAPA and Effectiveness Checks
- How to Write Effective Standard Operating Procedures (SOPs)
- Human Error Prevention
- Winning Cleanroom Behaviors
- In-Process Sampling and Testing
- Plant and Clean Utilities for GMP Manufacturing
- Equipment Maintenance
- Data Integrity Awareness: ALCOA+
- Process Validation: Core Concepts
Refresh
- Good Manufacturing Practice Refresher Course
- GxP Hot Topics: Cybersecurity Refresher Course
- Good Documentation Practice Refresher Course
- Data Integrity Refresher Course
- 5 Key Elements of Good Manufacturing Practices
- Access Control
- Clean Work Surfaces
- Cleaning vs. Disinfecting
- Clothing Requirements for Grades A/B, C and D
- Data Integrity Applies to Everyone in the Organization – ALCOA+ [Video]
- How Self-Inspection Leads to Continuous Improvement
- How to Act When an Inspector is On Site
- Ignoring Issues and the Repercussions That Can Follow
- Quality Culture In Lean Teams
- Requirements for All Staff in an Aseptic / GMP Environment
- The Collective Responsibility of Data Integrity in the Life Science Industry
- The Difference Between Audits and Inspections
- The Four Main Sources of Pharmaceutical Contamination
- The Importance of Contamination Control
- The Importance of Environmental Monitoring
- The Importance of Proper Hygiene
- The Principles of Production Operations in a GMP Environment
- The Significance of Proper Gowning
- Top 10 Principles of Good Manufacturing Practices (cGMP)
- What is Drug Contamination?
- What is Drug Cross Contamination?
Good Manufacturing Practices (cGMP) - Beginner
The Devastating Effects of Not Following GMP
15 mins
Basic
Good Documentation Practices (GDocP)
How to Write Effective Standard Operating Procedures (SOPs)
60 mins
Basic
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
Good Manufacturing Practices (cGMP) - Beginner
Requirements for All Staff in an Aseptic / GMP Environment
1 min
Good Manufacturing Practices (cGMP) - Beginner
The Four Main Sources of Pharmaceutical Contamination
3 mins
Good Manufacturing Practices (cGMP) - Beginner
The Principles of Production Operations in a GMP Environment
1 min
Good Manufacturing Practices (cGMP) - Beginner
Top 10 Principles of Good Manufacturing Practices (cGMP)
1 min