Most cleaning validation programs must rely on data from direct surface swab samples backed by a surface swab recovery study. Attend this webinar to learn about how to perform cleaning validation studies , examples are taken from those that execute on a day to day basis in a variety of industries. Participants will gain an understanding of the necessary controls required for a defensible study.
Areas Covered in the seminar:
- Fundamentals of a sound cleaning validation strategy.
- Understanding of controls required for a defensible study.
- Interpretation and analysis of swab recovery data.
- Overview of Cleaning Validation and TOC Technology (analyzer validation and method validation).
- Recovery Studies – structure and intricacies.
- Discussion of Recovery Study Data Analysis.
- Expected recoveries – what is acceptable?
Who will benefit:
This webinar will provide valuable assistance to all regulated companies that need to validate their production processes, including companies in the Biopharmaceutical and Pharmaceutical fields. The employees who will benefit include:- Quality Assurance professionals and mangers
- Validation professionals, practitioners and mangers
- Operations professionals and mangers
- Engineering professionals and managers
- Regulatory professionals
Instructor Profile:
Keith Bader, is the Director of Technical and Quality Services at Hyde Engineering + Consulting, Keith is responsible for the implementation of quality and validation standards for Hyde Engineering + Consulting on a corporate wide basis. In addition, Keith serves as project manager for validation and engineering projects, as well as providing high level strategic consultation to Hyde Engineering + Consulting clients.
Since joining Hyde in 1999, as a Control Systems Engineer, Keith has gained experience on a variety of projects ranging from project engineering and commissioning to process and cleaning validation projects. Keith has worked on equipment ranging from stand-alone unit operations such as CIP and Ultrafiltration skids, to entire process trains.
Prior to joining Hyde, Keith was a Research Engineer at TDA Research in Wheatridge Colorado where he was responsible for the synthesis and testing of novel catalysts, and advanced ceramic composites. All of the work at TDA was funded by various government agencies, including NASA, DOE, and the EPA, through the SBIR program.
Keith earned his bachelor’s degree in Chemical Engineering from the University of Colorado at Boulder in 1995.
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