Content

Applied Cleaning Validation Practices: A STERIS Master Class

Delivery methods

Course content

analytical course

Special Topics

This course can count toward your Professional Certificate in Biomanufacturing Science.

Why should you attend?

This two-day intensive course presented by invited industry experts covers industry practices, 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 addresses several current challenges to cleaning and validation in the biopharmaceutical industry and includes case studies, best practices, and hands-on exercises using state-of-the-art bioprocessing equipment located in the BTEC facility. The course covers numerous topics, including the following:

  • Lifecycle 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

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 coffee and tea
  • Lunch
  • Afternoon break
  • Certificate of completion

Instructors

Antonio Ortiz has over 18 years of experience in research and development, technical transfer, process and cleaning validation, regulatory submissions, and Good Manufacturing Practices (GMP) manufacturing troubleshooting and investigations. He holds a master’s degree in biomedical engineering and a bachelor’s degree in chemical engineering. Prior to joining STERIS Life Sciences, Antonio spent time at Stryker, Bausch + Lomb, Catalent and Apotex in positions including Validation Engineer, Process Engineer, and Technical Services Scientist. Antonio provides technical support to STERIS Life Sciences Customers by integrating multiple areas of specialization to resolve complex pharmaceutical and biopharmaceutical challenges. He also administers global pharmaceutical and biopharmaceutical industry education programs and presents at industry conferences. Antonio is an active member of the International Society for Pharmaceutical Engineering (ISPE) and the Parenteral Drug Association (PDA).

Brian Bosso is a Technical Services Manager for STERIS Life Sciences. He has responsibility for providing global technical support for pharmaceutical detergents and critical environment products and their application and validation. Brian has over 13 years of experience in the pharmaceutical and biopharmaceutical industries having previously worked at Sandoz, Aldevron, and as an onsite consultant on projects in North America, Europe, and Asia. He has held supervisory and management positions with responsibilities in areas including developing and implementing cleaning validation process lifecycle, process design, analytical method development, GMP quality and regulatory remediation. He earned a Bachelor of Science degree in chemistry from the Colorado School of Mines.

Fee

$2,000

Important Information for In-person Course Participants

Please read about BTEC’s policies on payment, cancellation, pre-course communication and other important information for in-person courses offered on site at BTEC.