Product Details
As a successful drugmaker, you know there’s no passing the buck to suppliers and vendors when it comes to meeting regulatory requirements.
You must choose suppliers wisely and exercise careful oversight. The expert contributors to Supplier Management for Drugmakers will enable you to do just that. They share how to pick the highest-quality and most reliable firms and how to hammer out a contract that will hold the supplier to your standards.
Supplier Management for Drugmakers 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 Drugmakers: Qualification, Contracts and Audits will help you maintain quality and improve compliance in upgrading your supplier management skills by:
- Understanding core competency areas on which to evaluate suppliers
- Determining what constitutes due diligence in researching suppliers
- Scoring and comparing suppliers
- Creating a certified supplier list
- 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 Drugmakers contains copies of FDA and ICH guidances and hands-on tools for managing your supplier-related responsibilities.
Enhance your supplier management skills and pick the right supplier, craft the best contract and perform audits with Supplier Management for Drugmakers: Qualification, Contracts and Audits. Order your copy today.
About the Contributors
This report was contributed to by various supplier management experts, including:
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
- Quality unit professionals
- Vendor relations personnel
- Legal personnel
- Regulatory professionals
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Contributors:
Steven Sharf and John Avellanet
ISBN-13:
978-1-60430-146-5
Publication date:
Aug. 2020
Page count:
181
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