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4-Region internal audits: Medical Device Quality System audits that cover internal regulatory compliance for FDA, Europe, Canada and Japan

Instructor: Phil Smart
Product ID: 700847
  • Duration: 60 Min

recorded version

$249.00
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

$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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This webinar will provide valuable assistance to all regulated medical device companies who implement internal audit programs to comply with US and international regulations.

Description

This presentation will provide an understanding of how to integrate US, Canadian, European and Japanese regulations into an effectively documented and implemented internal audit program.

All major regulatory schemes require internal audits to be performed by competent, trained individuals, and that these audits go into sufficient depth regarding specific regulatory processes for a given region. Evidence of this is seen through third-party audit findings from FDA, European Notified Bodies, CMDCAS Registrars and MHLW/PMDA. Assessors within the organization should have at least basic knowledge of these regulations and their expectations for internal audits. This presentation will provide an understanding of how to integrate US, Canadian, European and Japanese regulations into an effectively documented and implemented internal audit program.

Areas Covered in the seminar:

  • Review of internal audit requirements for QSR, CMDR, MDD and JPAL.
  • Principles of Regulatory Auditing of quality management systems per GHTF Guidance documents from 2006 and 2007.
  • Developing and internal audit program and documentation which include regulatory assessments.
  • What are regulatory processes and how must they comply?
  • Audit focus for FDA compliance.
  • Audit focus for MDD/AIMDD and IVDD Compliance.
  • Audit focus for Canadian Medical Devices Regulations (CMDR) Compliance.
  • Audit focus for foreign manufacturers in compliance with Japanese PAL.

Who will benefit:

This webinar will provide valuable assistance to all regulated medical device companies who implement internal audit programs to comply with US and international regulations. The employees who will benefit include:

  • Internal auditors, audit managers and 2nd-party auditors performing assessments of regulatory processes
  • Regulatory Managers and support personnel
  • Internal process owners who will be audited to the requirements of regulatory compliance
  • Consultants

Instructor Profile:

Phil Smart, is founding member of RA/QA International. He is an Auditor, Consultant and Instructor to 21 CFR Part 820, CMDR/CMDCAS, MDD, MHLW/PMDA/Japanese PAL. Phil has been a Notified Body Lead Assessor for over 15 years with over 450 3rd-party, 2nd-party, and internal audits of medical device manufacturers in the Americas, Europe, Japan and Southeast Asia.

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