Task:
The company needed to comply with GxP requirements. However, the responsible employees lacked the necessary knowledge, processes, and tools for informed decision-making and documentation.
Objective:
Raise employee awareness about GxP topics and introduce the required tools.
Milestones:
- 6 modules, each 3.5 hours long
- Module 1: Basics
- Module 2: Specification
- Module 3: Risk Assessment
- Module 4: Documentation
- Module 5: Deviations and Errors
- Module 6: Root Cause Analysis
- Final presentation
Approach:
Employees were trained in 6 modules covering GxP topics. At the end of the training, they presented a self-chosen project.
The modules provided tools and methodologies covering the entire GxP lifecycle.
Conclusion:
Employees were sensitized to GxP topics and their associated responsibilities. They became capable of applying the necessary tools and creating the required documentation.
Tools:
- Specification: URS (User Requirements Specification), VOC (Voice of Customer), Project Plan
- Risk: FMEA (Failure Modes and Effects Analysis), Risk Assessment Matrix,
Cost-Benefit Analysis - Documentation: ALCOA+ (Attributable, Legible, Contemporaneous, Original, Accurate), SOP (Standard Operating Procedures)
- Deviations and Errors: 8D (Eight Disciplines), CAPA (Corrective and Preventive Actions)
- Root Cause Analysis: Ishikawa Diagram (Fishbone Diagram), 5 Whys
Feedback from the training sessions:
- Short and concise
- Learning by doing
- It was very engaging
- Very well prepared
- Well explained and easy to understand
- Very informative
- Only essential information in the PowerPoint
- Thank you for the 1:1 support
- Engaging and informative
- Very well explained
- Easy to follow
- Very well presented
- Patient instructor
