The 19 May 2022 training will be “Cleaning Validation – Prerequisites”.

The training will build upon the 28 Feb 2021 training “Cleaning Validation – An Overview”.

The training will focus on Cleaning Program approach, considerations, and tasks to be documented and/or completed prior to executing Cleaning Validation.  The combined activities yields a proactive and customized Cleaning Program that establishes understanding of and demonstrates control of the Cleaning Process which will ensure compliance to Regulatory requirements and guidance.

John VanBerschot has 21+ years of experience in the pharmaceutical and biopharmaceutical industries. He has successfully implemented full Cleaning Validation programs and supported client’s efforts to partially revise existing programs for Cleaning Validation, with emphasis upon regulatory compliance for both the United States and Europe.

In addition, he has experience with commissioning and qualification of manufacturing process and laboratory analytical equipment, including standard operating procedures and system lifecycle documentation generation, execution, review, and approval from both Qualification and Quality Assurance aspects.

Also, he has experience with Quality Control completing analysis of manufacturing process, utility, and cleaning samples, as well as accomplishing numerous laboratory bench studies supporting Cleaning Validation such as analytical method verification and validation, swab and rinse recovery, visual residue limit, degradation, worst case residue, and relative cleanability.

John has presented twice at BTEC (Biomanufacturing Training and Education Center, at North Carolina State University): “Cleaning Validation Swab Recovery Studies and Analysis: A Hands-On Workshop” and “Setting Cleaning Validation Acceptance Criteria Limits.” John also co-presented a poster presentation at the 2019 ISPE event in Las Vegas: “Changing Role of Toxicology within Cleaning Validation with Regards to Industry Trends and Regulatory Requirements.”