This 2-day intensive course presented by invited industry experts will cover industry practices and regulatory expectations and trends in cleaning and cleaning validation.  It is designed for biopharmaceutical manufacturers concerned about developing or maintaining a high-quality, efficient, and compliant cleaning process. The training will address several current challenges to cleaning and validation in the biopharmaceutical industry, and include case studies, best practices, and hands on exercises using state-of-the-art bioprocessing equipment located in the Montreal CASTL biomanufacturing training facility.   

Who should take this course?

This course is designed for those in Quality Assurance, Regulatory, Quality Control, Validation, Operations, Microbiology, Facilities Maintenance, Engineering, and Plant Management roles

Topics

• An overview of the life cycle approach to cleaning validation, process design and qualification, protocols and grouping strategies, dedicated equipment and campaigns and how to set acceptance criteria. 
• Example of global regulatory documents and citations.

Assessment

A competency-based assessment will be conducted at the conclusion of the course to certify participants’ proficiency in the theoretical concepts covered over the two days.