Study Group 4 Work Plan: 2008 to 2010

Area of work
Structure of GHTF-SG4 “Regulatory Auditing” Documents
Membership
Current status
Work plan 2008 - 2010

1. Area of work

The area of work of GHTF SG 4 is guidance on “Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers” with the following main topics:

General Requirements
Regulatory auditing strategy
Regulatory auditing reports
Auditor Training

It is understood that the regulatory auditing of quality systems includes the auditing of risk management systems, if this is a regulatory requirement.

2. Structure of GHTF-SG4 “Regulatory Auditing” Documents

The documents worked out in GHTF – SG4 “Regulatory Auditing” are “Guidelines for Regulatory Auditing of Quality Management Systems of Medical Devices”.

The documents are structured as follows:

Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers – Part 1: General Requirements
Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers – Part 2: Regulatory Auditing Strategy
Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers – Part 3: Regulatory Audit Reports
Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers – Part 4: Multiple Site Auditing
Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers – Part 5: Audits of Manufacturer Control of Suppliers

3. Membership

Active members consist of representatives from all founding members. CAs, CABs and industry representatives are present from Australia, Canada, Europe, Japan and USA.

Chair: Jan Welch – FDA
Secretary: Elisabeth George – US Industry

4. Current status

Document	Name of Document	Document #	Status
Part 1	Guideline for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers – Part 1: General Requirements	SG4/N28R4:2008	FINAL 24. October 2008
Supplement 2	Training Requirements for Auditors (Guidelines for Regulatory Auditing of Quality Systems of Medical Device Manufacturers – Part 1: General Requirements – Supplement 2)	SG4(00)3	FINAL 30. October 2000
Part 2	Guideline for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers – Part 2: Regulatory Auditing Strategy	SG4/N30WD1	Revision Proposed. Under Review since 16.September 2009
Part 3	Guideline for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers – Part 3: Regulatory Audit Reports	SG4/N33R16:2007	FINAL 19.November 2007
Part 4	Guideline for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers – Part 4: Multiple Site Auditing	SG4/N83R5	Proposed. Under Review since 16.September 2009
Part 5	Guideline for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers – Part 5: Audits of manufacturer control of suppliers	SG4/N84	Proposed. Pending Review.

5. Work plan and meetings 2006 – 2008

N83 Part 4: Multiple Site Auditing: Posted to GHTF Website for review on September 16, 2009 with a 4 month comment period. Comment collection and review by SG anticipated by late February.
N30 Regulatory Strategy: Updated Annex to support Software Ad Hoc Working Group inputs. Posted to GHTF Website for review on September 16, 2009 with a 2 month comment period. Comment collection and review by SG anticipated by late December.
N84 Part 5: Audits of Manufacturer Control of Suppliers: Presented to Steering Committee for vote on November 11, 2009. SC approved for review. SC approved 4 month comment period. Comment collection and review by SG anticipated by mid May.
Based on comments and amount of update, SG 4 proposed meeting or teleconference in May or June to finalize these three documents. Upon completion of document submission to GHTF Secretariat for posting to GHTF website, SG 4 will propose to SC move to maintenance mode.

Detailed Work plan:

Year	2008				2009			2010
Quarter	2	3	4	1	2	3	4	1	2
N28 General Requirements	Stage 5		Stage 6
N83 Multiple Site Auditing	Stage 2				Stage 4		Stage 5		Stage 6
N84 Auditing of Manufacturer Control of Suppliers	Stage 2				Stage 4		Stage 5		Stage 6
N30 Regulatory Auditing Strategy					Update to support SW AHWG Proposal		Stage 5		Stage 6
SG 4 Meetings	April 1-3 Paris		Oct 14-17 Ottawa		May 10-15 Toronto				May or June TBD

Elisabeth George, Secretary SG 4
18. November 2009

Updated 23 December 2009

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