In this Cleaning Validation training will discuss strategies that assure that cleaning validation is started at the optimal time of the product development cycle, current trends, and some of the challenges that must be addressed.
Cleaning validation is required prior to product licensure. Biopharmaceuticals may require different sorts of assays, and defining an acceptable residue limit can be a challenge.Early in development, cleaning monitoring is required. This talk will discuss strategies that assure that cleaning validation is started at the optimal time of the product development cycle, current trends, and some of the challenges that must be addressed.
Cleaning validation is required prior to product licensure. Biopharmaceuticals may require different sorts of assays, and defining an acceptable residue limit can be a challenge.Early in development, cleaning monitoring is required. This talk will discuss strategies that assure that cleaning validation is started at the optimal time of the product development cycle, current trends, and some of the challenges that must be addressed.
Areas Covered in the seminar:
- Biopharmaceuticals vs. drugs - differences
- Cleaning assessment and monitoring - early development
- Strategies for efficient cleaning validation
- Microbiological concerns
- Investigations, exceptions, and cycle re-development
- Considerations when using a CMO (contract manufacturer)
- Recent regulatory findings related to cleaning and validation
- Risk assessment, new ICH draft guidelines, and other regulatory trends
Who Will Benefit:
- Development scientists
- QC and analytical methods development scientists and managers
- QA managers and personnel
- Manufacturing
- Validation engineers
Course Provider
Paula Shadle,
