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This all-encompassing live web training course will explore the best practices and regulatory expectations for pharmaceutical GMP facility design, with an emphasis on biologic products.  Facility design standards and regulatory expectations will be explored and discussed, as well as the strategies for good facility design, including cleanrooms, flows, HVAC standards and more.

 

Participants will gain an understanding of the overarching principles pertaining to biologics facility design that will meet regulatory expectations for both new facilities and retrofitted or renovated facilities.  In addition, personnel flows and controls, quality standards, manufacturing operations, equipment and process flows will be explored relative to facility design.

 

Learning Benefits:

 

  • Gain a better understanding of regulatory expectations for GMP facility design
  • Understand facility design expectations for biologics and biotech products
  • Understand regulatory and quality standards for facility design
  • Understand cleanroom design
  • Learn the best practices for cleanroom design
  • Discover how proper facility design leads to a quality product
  • Understand selected facility design issues required for certain biologic products

 

 

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