Facility Design Considerations

Instructor: John R Godshalk
Product ID: 701210
  • Duration: 45 Min

recorded version

1x Person - Unlimited viewing for 6 Months
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Recorded Link and Ref. material will be available in My CO Section

Training CD

One CD is for usage in one location only.
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CD and Ref. material will be shipped within 15 business days

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In this General manufacturing training we will discuss Regulatory facility design considerations with guidelines and standards for successful facility design.

The overarching facility design considerations are discussed for the biologics industry. Regulatory facility design considerations are discussed with guidelines and standards for successful facility design. This is a high-level introduction to the regulatory requirements for facilities with an emphasis on GMP compliance for biologics facilities. Controlled manufacturing environments are discussed, including closed systems, clean room design, flow patterns, flexible spaces, lighting, and cleanroom surfaces.

Areas Covered in the seminar:

  • Required design elements for facilities.
  • FDA expectations for facility design.
  • Common errors and pitfalls in cleanroom design.
  • Industry standards for GMP spaces.
  • What FDA will typically inspect with respect to facilities.
  • Facility commissioning and validation.
  • Designing for good flow patterns.
  • Personnel Controls and GMP design.

Who will benefit:

  • QA managers and personnel
  • Regulatory Affairs personnel
  • Compliance managers and personnel
  • Project Managers

Instructor Profile:

John R Godshalk, currently works for the Biologics Consulting Group as a Senior Consultant. John served as a Senior Review Biochemical Engineer and Lead cGMP inspector in the Division of Manufacturing and Product Quality at CBER, FDA. He contributed to formulation of FDA policy as a member of the committee writing the Guidance Document for the Facilities and Controls for Cellular and Gene Therapy Manufacturing Operations. John has provided advice to industry on regulatory strategies, pharmaceutical product facility design, best practices, and validation approaches that meet FDA licensing requirements. John received his B.S. in chemical engineering from N.C. State University and his M.S.E. in biochemical engineering from Johns Hopkins University.

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