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GHTF (Global Harmonization Task Force) is changing the global medical device industry; will it help you or hurt you?

Instructor: Edwin L Bills
Product ID: 701312
Training Level: Intermediate
  • Duration: 90 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

Customer Care

Fax: +1-650-963-2556

Email: customercare@complianceonline.com

Read Frequently Asked Questions

This GHTF (Global Harmonization Task Force) training will discuss current and future guidance developed and in development by GHTF and will also explore how the GHTF influences regulation of medical devices by member and non-member countries.

FACT: Regulatory agency representatives and medical device trade association’s representatives from around the world have been meeting and drafting guidance documents for a decade. Medical device companies should be aware of the content of the documents and how they may affect their business. Some of the guidance has been adopted for use in countries, such as the document on Process Validation, which is adopted for use in the US by FDA replacing its own guidance document. The strategies developed by GHTF are also affecting the development and implementation of new regulations in both developed and developing countries.

The presentation is designed to inform company personnel of the structure of the GHTF (Global Harmonization Task Force), its purpose, its membership, and how the organization functions. This presentation will discuss current and future guidance developed and in development by GHTF (Global Harmonization Task Force). We will also explore how the GHTF (Global Harmonization Task Force) influences regulation of medical devices by member and non-member countries. Also the role of voluntary standards and their influence in GHTF will be discussed.

Areas Covered in the seminar:

  • What is the Global Harmonization Task Force and its mission?
  • What is the authority of the GHTF?
  • What areas is the GHTF working to develop guidance?
  • What documents have been released by GHTF and where can they be found?
  • What changes should a company make as a result of GHTF guidance?
  • How can a company influence GHTF documents?

Who will benefit:

This presentation is designed for medical device company personnel with responsibilities in regulatory affairs and quality systems, including procedure development.

  • Regulatory Affairs managers and staff
  • Quality Systems Managers
  • Quality Engineers
  • Procedure Developers

Instructor Profile:

Edwin L. Bills, is the Principal Consultant for Bilanx Consulting LLC, a consulting firm that provides assistance to medical device companies in compliance with US FDA regulations. Edwin has over 20 years experience in the medical device industry and has participated in inspections in seven different FDA. He has been in the primary role for both leading the manufacturing team in an inspection and responding to the FDA inspection reports. In his consulting role he has assisted companies in Warning Letter responses. Edwin has also participated in training FDA personnel in the Quality System Regulation.

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