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Course description

Key Topics Covered:

Who Should Attend?

Learning Outcomes

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 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 facility. 

  • 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

Personnel from Quality Assurance, Regulatory, Quality Control, Validation, Operations, Microbiology, Facilities Maintenance, Engineering, Plant Management disciplines.

On completion of the course, delegates will be able to:

  • Develop effective and validatable cleaning procedures
  • Develop troubleshooting skills to address cleaning challenges
  • Understand issues to consider and gain practical insight into swabbing, analytical methods, identifying worst case locations, and other 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
  • Be conversant with approaches suitable for use in treating rouge and biofilms
  • A competency based assessment will be undertaken at the end of the course. This will certify proficiency in the theory and practical skills
Section 1
Final Quiz