Location: National Institute for Bioprocessing Research & Training

Register now for the STERIS Master Class: Applied Cleaning Validation Practices

Dates: 30th & 31st August 2017
Fosters Avenue, Mount Merrion, Blackrock, Co. Dublin, Ireland
Cost: €1500
Register here or email: training@nibrt.ie


This 2-day intensive course presented by invited industry experts will cover industry practices and regulatory expectations and trends in cleaning and cleaning validation. 
 
The course is designed for biopharmaceutical manufacturers who are concerned about developing or maintaining a high-quality, efficient, and most importantly, 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 NIBRT facility.  


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

For more information click here.