ComplianceOnline

Preparing for FDA Inspections of Devices and Combination Products

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

recorded version

$299.00
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

Training CD

$500.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

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Fax: +1-650-963-2556

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Read Frequently Asked Questions

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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