Simplifying Global Compliance
Transforming the Medical Device Critical Process Supply Chain - Webinar CD/Transcript
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Transforming the Medical Device Critical Process Supply Chain: A State-of-the-Art Quality Oversight Approach to Patient Safety
MedAccred is a device industry-led audit and accreditation program for critical manufacturing processes that employs expert auditors to conduct rigorous process audits across the gobal supply chain. While quite different from quality system audits, the two approaches can work together to boost quality and patient safety to new levels.
Yet MedAccred has been slow to catch on. Far too few devicemakers understand it, let alone make use of it.
Now, FDAnews has brought together two MedAccred thought leaders (from J&J and Stryker), plus a MedAccred suppler (Global Technologies) for presentation introducing you to this innovation in supply-chain auditing. You’ll discover how to:
- Meet FDA requirements for purchasing controls via the tiers in the complex global supply chain
- More effectively improve quality in key critical process areas
- Verify that suppliers have critical process capabilities, necessary equipment, controls, qualified personnel, process validation and sub-tier controls
- And much more!
Every devicemaker that depends on global suppliers shares the same concerns: Iffy quality control, potential sanctions from the FDA or global regulators, legal liability, harm to patients. MedAccred offers the promise of addressing each of these concerns. It’s time you learned more.
- Corporate leadership
- QA/QC/QR
- Regulatory affairs Procurement/sourcing
- Supply chain management
- Risk management
- Legal counsel
Scott Dauphinee, Director-Supplier Quality & Strategy, DePuy Synthes-J&J. Mr. Dauphinee is a senior executive in charge of J&J’s implementation of the MedAccred program, and a leader of the MedAccred Management Council.
Scott Goolsbey, Supplier Controls Manager, Stryker. Mr. Goolsbey is team leader for the global rollout of Stryker’s MedAccred program, and a leader of the MedAccred Management Council.
Paul Hugo, Director-Corporate Quality, Global Technologies. Mr. Hugo won the first global MedAccred Supplier Accreditation in Electronics. He provides a supplier’s perspective on the MedAccred program.