Location: NIBRT, Blackrock, Co. Dublin, Ireland

We are excited to be back at the National Institute of Bioprocessing Research & Training (NIBRT) to host a STERIS Master Class on applied cleaning validation practices. This intensive course will cover industry practices and regulatory expectations and trends in cleaning and cleaning validation. This course is designed for biopharmaceutical manufacturers who may be concerned about developing or maintaining a high-quality, efficient, and more importantly compliant cleaning process.

Key Topics Covered:

• Life cycle approach to cleaning validation
• CIP, COP, Manual cleaning methods
• Cleaning chemistries and application parameters
• Process and engineering issues
• Laboratory studies and scale up
• Cleaning process equipment-bioreactors, rings, membranes
• Cycle development
• Process design and qualification
• Setting acceptance criteria
• Rinse and swab sampling
• Analytical methods and validation
• Protocols and grouping strategies
• Dedicated equipment and campaigns
• Continuous improvement
• Stainless steel maintenance
• Bioburden and biofilms
• Global regulatory documents and citations

Who Should Attend? Personnel from Quality Assurance, Regulatory, Quality Control, Validation, Operations, Microbiology, Facilities Maintenance, Engineering, Plan Management disciplines.

Click Here to Contact NIBRT