Cleaning Validation Swab Recovery Studies and Analysis

Why Should You Attend:

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 Webinar:

• 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 Sr. Director of Technology at Hyde Engineering + Consulting. 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 is responsible for the identification of new approaches and technologies to streamline cleaning validation operations, and aid Hyde’s clients in the design and execution of strategic studies in support of their validation programs. To accomplish this, Keith founded Hyde Engineering’s CORE laboratory for the development of cleaning processes at the bench scale and the subsequent translation of those processes to pilot and manufacturing scale. Prior to joining Hyde, Keith was a Research Engineer at TDA Research in Wheatridge Colorado. Keith earned his bachelor’s degree in Chemical Engineering from the University of Colorado at Boulder in 1995.