Recorded: Access recorded version, only for one participant unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
Corporate Recorded: Access recorded version, Any number of participants unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
This course explores some of the best practices of pharmaceutical facility design with an emphasis on regulatory aspects. FDA and other global regulatory body requirements are discussed and the reasoning behind them.
Examples of floorplans and flows (people, product, etc.) are examined and discussed. Specifics for fixtures, finishes, HVAC and other design aspects of cleanrooms are discussed in terms of current practices and GMP requirements. Examples of design choices for pressurization, flows and HVAC zones are given along with their possible application. Design specifications for both open and closed systems are discussed along with current standards.
Why should you Attend: The attendee will learn what is important in facility design from the FDA and regulatory standpoint. The attendee will understand what FDA looks for during a facility inspection. The attendee will be able to minimize possible design errors which are difficult and expensive to fix post-build. The attendee will understand what FDA looks for in reviewing the facility design and the flow patterns.
Areas Covered in the Session: