MedAccred Supplier Forum / Task Group / Management Council– Event Invitation

The Performance Review Institute (PRI) and MedAccred Management Council participants invite you to attend a Supplier Forum, Technical Task Groupsand Management Council events taking placeon Tuesday, May 12 and Wednesday, May 13, 2015 in Pittsburgh, Pennsylvania at the Omni William Penn Hotel.

Dates: May 12-13, 2015

Location: Omni William Penn Hotel

530 William Penn Place,

Pittsburgh, PA 15219

Purpose: MedAccred Supplier Forum (May 12 – All Day) – Event organized to educatenew companies (manufacturers and critical process suppliers) and individuals interested in the MedAccred program and to prepare suppliers for MedAccred audits. The Forum will cover background on PRI and MedAccred, the MedAccred audit process, and practical tools to prepare suppliers for MedAccred audits (Internal Auditing, RCCA).

Technical Task Group Meetings (May 13 – All Day)–Simultaneous sessions focused on the technical aspects of a MedAccred audit (Cable & Wire Harness, Heat Treating, Plastics, PCBA, Sterilization and Welding). The technical Task Groups are where Audit Criteria are developed and the accreditation process is managed.

MedAccred Management Council (May 13 – All Day) –Meeting to report out on current Program activities. The Management Council is where policy and procedural decisions are made for the operation of MedAccred, Task Group coordination and development occurs, as well as oversight of the accreditation process.

AGENDA AT-A-GLANCE

Tuesday, 12 May 2015

MedAccred Supplier Forum – 8:00am – 5:00pm

Wednesday, 13 May 2015

Track 1: Technical Task Group Meetings – 8:00pm – 5:00pm

Track 2: MedAccred Management Council – 8:00am – 5:00pm

Tuesday, 12 May 2015

Title:MedAccred Supplier Forum

Format:Face to Face / Classroom Setting

Duration:9 hours

Expected Attendees: Medical Device OEMs, Contract Manufacturers and Suppliers new to the MedAccred Program

Objectives:Event organized to educatenew companies and individuals interested in the MedAccred program and to prepare Suppliers for MedAccred audits. The Forum will cover background on PRI and MedAccred, the MedAccred audit process, as well as provide practical tools that can be used when preparing for a MedAccred audit.

Item Sequence / Agenda Item Description / Presenter(s) / Duration
1.0 / Introduction to PRI/MedAccred
  • PRI Overview
  • MedAccred Background
  • Program Structure
  • Benefits to Suppliers
  • QMS / Process Validation
/ PRI MedAccred Team / 8:00am
2.0 / MedAccred Audit Preparation
  • Audit Process (Scheduling Audit  Accreditation)
  • eAuditNet – Online Audit Management System
  • Program Document Overview (PD1300)
/ PRI eQuaLearn Trainer / 9:30am
3.0 / Overview of ISO 13485 & QSR, Medical Device Regulation / Paul Mehta /
Philips HealthTech / 11:00am
LUNCH / 12:00pm
4.0 / Internal Auditing
  • Prepare an internal audit plan
  • Conduct effective internal audits
  • Select qualified auditors
  • Obtain Management support
  • Design an internal audit program as an
    effective continual improvement tool
/ PRI eQuaLearn Trainer / 1:00pm
5.0 / Root Cause Corrective Action – MedAccred Style
  • Identify problems
  • Collect effective and relevant problem data
  • Understand and apply the concepts of direct, contributing and root cause
  • Design mistake proofing techniques
  • Implement effective preventive actions that will lead tocontinual improvement
/ PRI eQuaLearn Trainer / 3:00pm
ADJOURN / 5:00pm

Wednesday, 13 May 2015

Title:Track 1: Technical Task GroupMeetings

Format:Face to Face / Classroom Setting

Duration:9 hours (simultaneous sessions)

Expected Attendees: Subject Matter Experts (in each Technology area) from OEMs, Contract Manufacturers and Suppliers; other interested parties

Purpose: Simultaneous sessions focused on the technical aspects of a MedAccred audit (Cable & Wire Harness, Heat Treating, Plastics, PCBA, Sterilization and Welding). The technical Task Groups are where Audit Criteria are developed and the accreditation process is maintained.

Item Sequence / Agenda Item Description / Presenters / Duration
1.0A / PCBA and Cable & Wire Harness
  • Audit Checklist Review
  • Review current audit checklist structure, content, auditor requirements, etc.
  • Top 10 NCRs (from Aerospace perspective)
/ PRI Staff Engineers with support from Task Group members / 8:00am
1.0B / Heat Treating
  • Audit Checklist Review
  • Review current audit checklist structure, content, auditor requirements, etc.
  • Top 10 NCRs (from Aerospace perspective)
/ PRI Staff Engineers with support from Task Group members / 8:00am
1.0C / Plastics (Injection Molding and Resins)
  • Audit Checklist Review
  • Review current audit checklist structure, content, auditor requirements, etc.
/ PRI Staff Engineers with support from Task Group members / 8:00am
1.0D / Sterilization
  • Audit Checklist Review
  • Review current audit checklist structure, content, auditor requirements, etc.
/ PRI Staff Engineers with support from Task Group members / 8:00am
1.0E / Welding
  • Audit Checklist Review
  • Review current audit checklist structure, content, auditor requirements, etc.
  • Top 10 NCRs (from Aerospace perspective)
/ PRI Staff Engineers with support from Task Group members / 8:00am
Lunch / 12:00pm
2.0A / PCBA and Cable & Wire Harness
  • Audit Checklist development, Auditor Handbook development, etc.
  • Normal Task Group activity
/ PRI Staff Engineers, Task Group members / 1:00pm
2.0B / Heat Treating
  • Audit Checklist development, Auditor Handbook development, etc.
  • Normal Task Group activity
/ PRI Staff Engineers, Task Group members / 1:00pm
2.0C / Plastics (Injection Molding and Resins)
  • Audit Checklist development, Auditor Handbook development, etc.
  • Normal Task Group activity
/ PRI Staff Engineers, Task Group members / 1:00pm
2.0D / Sterilization
  • Audit Checklist development, Auditor Handbook development, etc.
  • Normal Task Group activity
/ PRI Staff Engineers, Task Group members / 1:00pm
2.0E / Welding
  • Audit Checklist development, Auditor Handbook development, etc.
  • Normal Task Group activity
/ PRI Staff Engineers, Task Group members / 1:00pm
ADJOURN / 5:00pm

Wednesday, 13 May 2015

Title:Track 2: MedAccred Management Council

Format:Face to Face / Roundtable

Duration:9 hours

Expected Attendees: MMC Voting Members, Task Group Members, PRI Management, Staff Engineers; other individuals interested in the MedAccred program

Purpose: Quarterly face to face meeting to report out on current program activities.

Item Sequence / Agenda Item Description / Presenter(s) / Duration
1.0 /

Opening Address and Welcome

  • Call to Order/Quorum Check
  • Introductions
  • Code of Ethics, Anti-Trust & Conflict of Interest
  • Review Agenda
  • Approval of Minutes
/ PRI - EVP and COO / 8:00am
2.0 /

Task Group Activities - Status update on recent activities at the Task Group Level

  • Electronic Circuits – PCBA Task Group
  • Cable & Wire Harness Task Group
  • Heat Treating Task Group
  • Plastics Task Group
  • Sterilization Task Group
  • Welding Task Group
/ PRI Staff Engineers / 8:15am
3.0 /

MMC Activities

  • Program Documents
  • Exceptions
  • PD1300 Revision
  • Balloting Procedure
/ PRI Staff / 10:00am

LUNCH

/ 12:00pm
4.0 / MMC Sub-team Activities
  • QMS
  • Process Validation
  • Contract Manufacturing
/ MMC Sub-team Leads / 1:00pm
5.0 /

Other Business and Open Discussion

  • eAuditNet Update – Software Validation
/ PRI Staff / 3:00pm
6.0 /

Rolling Action Item List (RAIL) Review

  • Review an action items that have been assigned during the meeting and ensure owners and due dates are assigned
/ PRI Staff / 4:30pm

ADJOURN

/ 5:00pm

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