Course Content:
Cleaning validation is a process to ensure that equipment cleaning procedures are removing residues to predetermined levels of acceptability.
- Introduction & Course Objectives
- Module 1 – Validation –Introduction (Terminology, Cleaning Validation Management System)
- Module 2 – Regulatory Background – FDA, IMB approach
- Module 3 – Designing a Cleaning Procedure
- Module 4 – Basic Chemistry of Cleaning
- Cleaning Strategies
- Sampling Methods
- Acceptance Criteria
- Module 5 – Best Industry Approach to Cleaning Studies
- Module 6 – Cleaning Methods
- Manual
- Clean in Place (CIP)
- Steam in Place (SIP)
- Clean out of Place (COP)
- Module 7 – Calculation of carry over limits
- Module 8 – Development of Bracketing procedures
- Module 9 – Hold Times (DEHT), (CEHT)
- Module 10 – Documentation
- Module 11 – Designing a Cleaning Validation Test Protocol
- Module 12 – Cleaning of Dedicated equipment
- Q&A
- Conclude & Follow Up Process
