MEDACCRED MANAGEMENT COUNCIL
MARCH 2016
UNCONFIRMED
UNCONFIRMED MINUTES
MARCH 10, 2016
WEBEX / TELECONFERENCE CALL
These minutes are not final until confirmed by the MedAccred Management Council in writing or by vote at a subsequent meeting. Information herein does not constitute a communication or recommendation from the MedAccred Management Council and shall not be considered as such by any agency.
WEDNESDAY, MARCH 10, 2016
1.0 OPENING COMMENTS
1.1 Call to Order / Quorum Check / Introductions
The MedAccred Management Council (MMC) WebEx & Teleconference Meeting was called to order at 11:00 a.m. EST, 10-Mar-2016, with the following representatives in attendance:
MMC Members Present
NAME / TITLE / COMPANY NAMEGary / Switzer / Senior Vice President of Medical Systems / Sanmina
Shonte / Pettiford / Quality Program Manager / Abbott
Tony / Faucette / Sr. Dir. Global Sterilization Services; Corporate/ Shared Services / Becton, Dickinson and Company
John / Hastings / Director of Supplier Quality Engineering, Plastics Category / Johnson & Johnson
Amir / Hussain / Supplier Validation Quality Engineer / Johnson & Johnson (DePuy Synthes)
Vance / Kyle / Joint Recon Supplier Quality Manager / Johnson & Johnson (DePuy Synthes)
Steve / Niedelman / Consultant / King & Spalding Law
Scott / Goolsbey / Supplier Controls Manager - Stryker / Stryker
Wendy / Gould / Sr. Director, Global Quality & Regulatory Systems / Synergy Health (Steris)
PRI Staff Present
Jerry / Aston / Associate Program Manager, Heat Treating / PRIConnie / Conboy / Director, Strategy and Business Development / PRI
Marcel / Cuperman / Senior Staff Engineer – Heat Treating / PRI
Susan / Frailey / Lead Staff Engineer – MQS / PRI
Hannah / Godfrey / Senior Specialist, Business Development Europe, MedAccred Co-Lead / PRI
Joanna / Kennedy / Manager, Communications and European Customer Relations / PRI
Julia / Markardt / Staff Engineer, PCBA and C&WH / PRI
Justin / McCabe / Senior Specialist, Business Development, MedAccred Co-Lead / PRI
Kellie / O’Connor / Program Coordinator, Nadcap & MedAccred / PRI
1.2 Code of Ethics, Anti-trust and Conflict of Interest
Justin McCabe showed the PRI Code of Ethics, Anti-trust and Conflict of Interest policy. To view the video, please use the following link: https://www.youtube.com/watch?v=skr4dB9YE8c&feature=youtu.be
1.3 A moment of silence was held in honor of Cheryl Work of Becton Dickenson & Co. who until her recent passing was the MedAccred Task Group Chairperson for Sterilization. A tribute will be published on the PRI website in recognition of the wonderful contributions she made to the program.
1.4 Connie Conboy reviewed the agenda.
2.0 MD&M West debrief
Connie Conboy reviewed the MedAccred events that took place at MD&M West. There was an excellent attendance and discussion at the Lunch & Learn, which involved a lively Q&A session between the panel and participants. Additionally, there was a conference presentation that took place the following day, MedAccred: Innovating Critical Process Manufacturing Oversight, which was very well attended and received.
3.0 upcoming audits
Hannah Godfrey gave a status update on the completed and upcoming audits for MedAccred. For more details, please see the chart below.
4.0 Task Group HIGHLIGHTS
PRI Staff Engineers provided a brief update on the status for their respective Task Group activities. For more details, please see the embedded document below.
5.0 process validation sub-team update
Justin McCabe gave a status update on the Process Validation Sub-Team’s activities.
Current Status:
· General-Focus GAP assessment being completed by each Task Group
· Level 1 Training conducted (8Mar16); Training materials in development
Next Steps:
· Address General-Focus Process Validation GAPs with Task Groups
· Develop Task Group-specific Process Validation Audit Criteria
· Develop Level 2 and 3 Training materials
6.0 upcoming events & opportunities
Hannah Godfrey reviewed the upcoming MedAccred Events:
Industry Events:
FDAnews - Medical Device Quality Congress (MDQC) – March 16, 2016
Washington DC, USA
· Presenter: Joe Pinto
· Accredited Supplier Perspectives: Ed Engelhard (Solar Atmospheres) & Paul Hugo (Global Technologies)
Medmarc Webinar – March 23, 2016
Online Webinar
· Presenter: Joe Pinto
· Registration is located on the Medmarc website
· Content:
§ How poor supply chain management presents problems for medical device companies
§ How the aerospace industry can serve as a model for the medical device industry
§ The role of supply chain management in FDA’s Case for Quality
§ Effective strategies for oversight and management of supply chains
Q1 Productions – 3rd Annual Medical Device Supplier Quality Conference – April 2016
Arlington, Virginia, USA
· Joe Pinto to participate in panel discussion
· Pre-event interview with Joe Pinto published
Implants 2016 – June 2016
Paris, France
· Keynote
· Booth
· Pre-event interview with Joe Pinto published
· Pre-event interview with Simon Adam (Johnson & Johnson) to be published
AdvaMed 2016 – October 2016
Minneapolis, Minnesota
· Booth
· Submitting Panel proposal
7.0 OTHER business
7.1 Batteries Sub-Team
We are still looking for volunteers to support the batteries sub-team. Justin McCabe sent an email request for SME participation on this team in January, so if anyone has a participant in mind, please forward those names to PRI Staff.
7.2 Johnson & Johnson Supplier Outreach
A 90-minute MedAccred Supplier webinar will take place on March 15. The focus is to raise awareness amongst the supply base, provide information on MedAccred and encourage suppliers to participate in the program.
8.0 RAIL REVIEW
Hannah Godfrey provided an update on our Rolling Action Item List (RAIL). Please see the table below for details.
ADJOURNMENT – 10-Mar-2016 – Meeting was adjourned at 12:00 p.m.
Minutes Prepared by: Kellie O’Connor,