Mark von Stwolinski to Teach ISPE Design Course
Sep 20, 2012
Mark von Stwolinski, Vice President of Facility Integration at CRB, will instruct a two-day classroom training course on Sterile Product Manufacturing Facilities in Chicago, Illinois on September 26 and 27, 2012. The course will focus on the newly published second edition of the ISPE Baseline® Guide: Sterile Product Manufacturing Facilities and the FDA’s newly published Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice to provide an understanding of the key requirements and GMPs for sterile manufacturing facilities.
The course is designed to cover regulatory philosophy, aseptic process and equipment considerations, aseptic clean room design and operation, differential pressure requirements, airlocks, basic utility systems, European HVAC considerations, basic commissioning and qualification issues, and a brief introduction to barrier isolation technology. Using the guides above for reference material throughout the instruction, attendees will be able to extend this knowledge back to their companies. Engineers, validation scientists, quality assurance specialists and manufacturing managers are encouraged to attend.
Von Stwolinski has over 20 years of experience in the design and construction of biopharmaceutical facilities worldwide. He is a contributing author and steering committee member for ISPE Biopharmaceutical and the Packaging and Warehousing Baseline® Guides as well as the update of the recently issued ISPE Baseline Guide Volume 3 – Sterile Product Manufacturing Facilities.