Location: Golden LEAF BTEC, NC

Join STERIS for this 2-day intensive course presented by invited industry experts that will cover industry practices and regulatory expectations and trends in cleaning and cleaning validation.  It 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 BTEC facility. 

The course will cover numerous topics including:

Lifecycle approach to cleaning validation
Cleaning chemistries & 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


Attend and you will:
Develop effective cleaning procedures that are able to be validated
Develop troubleshooting skills to address cleaning challenges
Understand issues to consider and gain practical insight into swabbing, analytical methods, identifying worst case locations, and issues associated with cleaning validation
Perform cleaning validation residue limits calculations
Integrate chemistry, microbiology, engineering, and validation principles in performing risk assessments
Understand regulatory expectations and best practices

Who should attend:
Scientists and engineers working in the Biomanufacturing industry including roles such as Quality Assurance, Regulatory, Quality Control, Validation, Operations, Microbiology, Facilities Maintenance, Engineering, and Plant Management disciplines.

Attend and you will receive:
Notebook containing all course lecture and lab materials
Morning break
Afternoon break
Certificate of attendance


Register here! Space is limited.