Product Details
As a successful devicemaker you know there’s no passing the buck to suppliers and vendors when it comes to quality and compliance.
You must choose suppliers wisely and exercise careful oversight. The expert contributors to Supplier Management for Devicemakers will enable you to do just that. They share how to pick the highest-quality and most reliable firms, hammer out a contract that will hold the supplier to your standards.
Supplier Management for Devicemakers covers the three phases of working with suppliers and vendors:
- Qualification section — you’ll understand how to evaluate prospects and score them on the most important factors, including communication, compliance, facilities, logistics and price
- Contracts section — you’ll know the 24 elements to cover in any supplier agreement, including technical transfer, change control, deviation handling, complaint management, quality review and records retention
- Supplier auditing section — your four-part plan will enable you to decide the who, what, when and how of overseeing your contractors, including conducting for-cause audits, qualities of an effective auditor and how to write effective audit observations
Supplier Management for Devicemakers: Qualification, Contracts and Audits will help you maintain quality and improve compliance by upgrading your supplier management skills by:
- Understanding core competency areas on which to evaluate suppliers
- Scoring and comparing suppliers
- Identifying critical control points
- Creating an approved supplier list
- Determining when a change in supplier requires a supplemental premarket approval application
- Ascertaining how much advance notice of an audit to give a supplier
- Developing a risk assessment methodology
- Recognizing the differences among system audits, procedure/process audits and product audits
- Knowing when and how to conduct a remote audit
Bonus: Supplier Management for Devicemakers contains copies of FDA and ICH guidances and hands-on tools for managing your supplier-related responsibilities.
About the Contributors
This report was contributed to by various supplier management experts, including:
Mike Heyl, a partner at law firm Hogan Lovells, primarily practices in the medical device area, focusing on quality systems requirements with special emphasis on adverse event reporting and field action requirements. He has conducted internal investigations of violations of federal regulations and provides advice on device-related regulatory issues. Mr. Heyl also has assisted with responses to FDA warning letters and Form 483s.
Steven Sharf is a principal at GMP Concepts. He has worked for several pharmaceutical companies in quality roles, including Merck, Boehringer Ingelheim, Schering-Plough and Novartis.
John Avellanet, managing director and principal of Cerulean Associates, is a former device and biopharma executive. Today he is an internationally acknowledged expert, speaker and syndicated author on cost-effective FDA compliance.
Who Will Benefit
Who Will Benefit:
- Quality unit professionals
- Vendor relations personnel
- Legal affairs personnel
- Regulatory professionals
Add to Cart
Contributors:
Mike Heyl, Steven Sharf and John Avellanet
ISBN-13:
978-1-60430-147-2
Publication date:
Aug. 27, 2020
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