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This course will build on the fundamentals of cleaning validation by expanding into development of cleaning programs utilized in the biotechnology and pharmaceutical industry. Prevention of product adulteration and product cross-contamination is critical to the manufacture of safe and efficacious drugs. Cleaning validation plays a crucial role in ensuring the delivery of intended product to the public.This course will contain both lecture and laboratory sections.
This 2 day, 16 hour course covers the following topics:
- Mechanisms of cleaning biopharmaceutical soils
- Product changeover
- Soil cleanability studies
- Overview of Clean-in-Place (CIP) and equipment systems
- Contamination and other relevant aspects of a cleaning program
- Design a cleaning validation program to include:
- Overview of sampling methodologies and sampling strategies
- Validation documentation examples
- Considerations for regulatory filings and audits
- Development of soil cleanability studies:
- Laboratory methodologies
- Application of results to cleaning validation and full-scale manufacturing
- Role of the cleaning validation in product change-over programs
- Risk analysis of product changeover
- Differences in clinical and commercial product changeover
- Product changeover strategies
- Apply knowledge via hands-on experiences:
- Examine and disassembly of cleaning equipment
- Operation of a cleaning system to examine fundamental operation, cycle design, cleaning solutions and sampling locations
- Discuss typical failures and contamination
Employees within manufacturing, Quality Control and Quality Assurance and all others with responsibilities in cleaning activities will derive benefit from this course.