Preparing for FDA Inspections of Devices and Combination Products

Instructor: John R Godshalk
Product ID: 701209
  • Duration: 60 Min

recorded version

1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Mar-2009

Training CD / USB Drive

One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days

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This FDA inspection training will explores how to prepare for an FDA inspection of a combination product or device and key behaviors for a successful combination product or device inspection.

This training explores how to prepare for an FDA inspection of a combination product or device. Combination products are defined along with a brief explanation of the Primary Mode of Action. The QSR and GMP regulations are discussed in reference to combination products. Inspection agendas and examples are given. What is emphasized during the inspection vs. what is in the application is discussed. How to avoid common pitfalls with combination products and strategies for a successful approval inspection are discussed. Know key behaviors for a successful combination product or device inspection.

Areas Covered in the seminar:

  • How to prepare for an FDA inspection of a combination product or device.
  • What to expect when FDA shows up for a combination product or device inspection.
  • Pitfalls to avoid during an inspection.
  • Good inspection behaviors and approaches.
  • What to do when conflict arises.
  • How to respond to an FDA 483.
  • Inspection Agendas and examples.
  • QSRs and GMPs

Who will benefit:

Companies who are or will pursue a combination product or device application, for employees in the following areas:

  • 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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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

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