Cleaning Validation Product and Equipment Grouping
Fred Ohsiek Overview
In the presentation, we will explore regulatory expectations; discuss common mistakes made; and learn what considerations should be taken when bracketing products and grouping equipment.
The presentation also includes a bonus material on how to sample during CIP cycle development and a case study on equipment grouping.
Why you should Attend
Firms often don't bracket products or group equipment due to fear of a regulatory finding during inspection or do it incorrectly and put the facility at inspection risk. Bracketing or grouping can lessen the cleaning validation footprint significantly and reduce validation timelines.
Improperly bracket products or grouped equipment are high risk and can lead to product recall or major regulatory findings
Areas Covered in the Session
- Regulatory expectations on bracketing and grouping
- Common mistakes when grouping equipment
- Science and risk-based justifications for grouping
- Equipment grouping case study
- Bonus - Cycle development sampling strategy
Who Will Benefit
- Heads of sites
- Validation
- Quality Assurance, and Operation Managers, and Validation Engineers Responsible for Cleaning Validation
Speaker Profile
Fred Ohsiek Fred Ohsiek earned his BS in Chemistry from University of South Florida. He has 24 plus years of validation FTE and consultant experience, with emphasis in cleaning validation. Prior to transitioning to pharma his experience includes 7 years of R&D while at the USDA.
He has been fortunate to work for 7 major pharmaceuticals (Catalent, AstraZeneca, Boehringer Ingelheim, Teva, Astellas, Bayer, and Novo Nordisk) where he was considered the cleaning validation SME in most of his roles.
Working with various routes of administration (OSD, parenteral, softgels) in green and brown field small and large molecule manufacturing projects has provided Fred a very broad cache of experience.
Fred also obtained “cleaning chemistry” experience while working as a Sr Global Technical Manager at Ecolab (Life Science division).
Currently, he supports industry by creating tailored justifications, reducing the validation footprint via risk assessments, creating startup CV programs, remediating legacy processes, and increasing manufacturing capability as a cleaning process/cleaning validation consultant. He enjoys solving complicated validaton issues.
He was one of the authors of the ISPE Cleaning Validation Lifecycle - Application, Methods, and Controls guidance, and he regularly presents at conferences, nationally and globally.