Fred Ohsiek - uventia

Fred Ohsiek

Fred Ohsiek

Fred Ohsiek

Principal Cleaning Process Consultant


Fred Ohsiek, who earned his BS in Chemistry from University of South Florida, resides in the NC RDU area. He has 24 plus years of validation experience as a FTE and consultant, with emphasis in cleaning validation. Prior to transitioning to pharma his experience includes 7 years in 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). In his current role as Principal Cleaning Process Consultant, 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. 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.

October 1, 2024
Looking to build compliant cleaning validation program and ensure that your next product is not affected by contamination?

DAY 1: OCTOBER 1st, 2024 | [WORKSHOP]

SESSION 1: Product bracketing and equipment grouping during Cleaning Validation

◆  Bracketing and grouping regulatory expectations.

◆  Common mistakes and misconceptions when bracketing and grouping.

◆  Science and risk-based approaches when grouping.

◆  Equipment grouping case study.

SESSION 2: CIP cleaning process optimization and sustainability

◆  CIP cleaning recipe.

◆  Elements of an optimized cleaning process.

◆  How to efficiently optimize a CIP cleaning process.

◆  Hidden benefits of optimizing legacy cleaning process.

◆  Explore cleaning development sampling strategy.

SESSION 3: Maintaining the Cleaning Validation program

◆  Efficient restart after a shut-down and cleaning after maintenance.

◆  When re-validation makes sense.

◆  Explore process for creating an efficient and robust science risk-based CPV program.

◆  Routine monitoring case study.

◆  Protocol reporting and validation compliance.

HPAPI Handling-Manufacturing Summit
September 29, 2021
Explore how pioneering pharma companies are approaching HPAPI development and processing. Recording of 2 days event sessions [12 video sessions].

DAY 1: SEPTEMBER 29th, 2021

SESSION: Risk-based cleaning validation

◆  Defining and implementing risk controls.

◆  LCM approach to cleaning based on quality risk management.

◆  ICH Q9 and HBEL principles to measure the risk level.

Speaker Details
  • Profession
    Principal Cleaning Process Consultant
  • Company
    VTI Life Sciences
Speaker Details
  • Profession
    Principal Cleaning Process Consultant
  • Company
    VTI Life Sciences