Global Harmonization Task Force (GHTF): CAPA Guidance Coming

For those of you who may not be aware, the Global Harmonization Task Force (GHTF)) offers many useful complimentary compliance guidance documents online on their website.

The GHTF was formed in 1992 in an effort to respond to the growing need for international harmonization in the regulation of medical devices. Since its inception, the GHTF has been comprised of representatives from five founding members grouped into three geographical areas: Europe, Asia-Pacific and North America. In 2006, membership expanded to include three Liaison body members; the Asian Harmonization Working Party (AHWP,) International Organization for Standardization (ISO) and International Electrotechnical Commission (IEC).

These documents, which are developed by five different GHTF Study Groups, provide a model for the regulation of medical devices that can then be adopted/implemented by national regulatory authorities.

In their March 2009 issue, the Silver Sheet publication stated that the FDA wants to continue to work through the GHTF, as its organization offers a strong global venue.

According to a study conducted by the Silver Sheet, CAPA ranks number 1 in the Top 10 Warning Letter Citations issued in 2008 by FDA related to medical devices. The GHTF is currently creating a CAPA guidance document by its Study Group 4. It is hoped the draft guidance will be released sometime in 2009.

For those of you who need information on CAPA now, enKap’s offering its CAPA training event, “Effectively Managing a CAPA Program: A Risk-Based Approach,” June 4-5, 2009, Hamilton Park Hotel & Conference Center, Florham Park, New Jersey

In February 2009, Study Group 3 of the GHTF released its guidance document entitled, "Quality Management System-Medical Devices-Guidance on the Control of Products and Services Obtained from Suppliers.”

For more information on supplier-related information, enKap offers its GXP Instructional Guide, “Supplier Qualification Programs: Establishment and Implementation,”as well as our training event, “Supply Chain Compliance: An Insider’s View of Effective Management Practice,” June 11-12, 2009, Hamilton Park Hotel & Conference Center, Florham Park, New Jersey.Our course instructor is John Daley, VP Quality Assurance, Distribution and Supply Chain, Boston Scientific.

enKap also offers its newest DVD on “Supplier Quality Agreements.” John Daley, VP Quality Assurance, Distribution and Supply Chain, Boston Scientific answers critical questions related to this topic.

Here are some of the links available for Final Documents from the GHTF:

Study Group 2

Offers guidances on postmarket surveillance, adverse reporting systems, content of field safety notices and comparison of device adverse reporting systems in U.S., Europe, Canada, Australia and Japan, etc..

Study Group 3

Offers guidances on quality management systems, including implementation of risk management principles and activities within a quality management system, process validation and supplier quality.

For more information on risk management, enKap offers its training course, Quality Risk Management Tools: Practical Applications,” June 9-10, 2009, Hamilton Park Hotel & Conference Center, Florham Park, New Jersey. Our course instructor is Eldon Henson, Director, Quality, Pharmaceutical Products, Covidien.

Study Group 4

Offers guidances on regulatory auditing for quality management systems, training requirements and more.

For more information on quality systems management, enKap offers its newest DVD “Managing Quality Systems,” by John Daley, VP Quality Assurance, Distribution and Supply Chain, Boston Scientific.

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According to a study conducted by the Silver Sheet, complaint handling ranked number 2 in the Top 10 Warning Letter Citations issued in 2008 by FDA related to medical devices. Our GXP Instructional Guide has just been released on the "Basic Principles of Complaint Handling"Included with that instructional guide is “Managing the Complaint Handling Process: A Compliance Narrative from a Fictional Company.”