MEDACCRED MANAGEMENT COUNCILMARCH 2016

UNCONFIRMED

UNCONFIRMED MINUTESMARCH 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 NAME

Gary 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 PRI

Connie Conboy Director, Strategy and Business Development PRI

Marcel Cuperman Senior Staff Engineer – Heat Treating PRI

Susan Frailey Lead Staff Engineer – MQS PRI

Hannah GodfreySenior 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

MEDACCRED MANAGEMENT COUNCILMARCH 2016

UNCONFIRMED

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.

MEDACCRED MANAGEMENT COUNCILMARCH 2016

UNCONFIRMED

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, 2016Online 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 2016Arlington, Virginia, USA

Joe Pinto to participate in panel discussion Pre-event interview with Joe Pinto published

MEDACCRED MANAGEMENT COUNCILMARCH 2016

UNCONFIRMED

Implants 2016 – June 2016Paris, 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, koconnor@p-r-i.org