Medical Device Supplier Quality A Step-By-Step Guide to Creating Ironclad Agreements

Held May 20, 2010

In an era of the global supply chain, supplier quality agreements are critical legal documents that are increasingly becoming required by regulatory agencies worldwide.

Here’s expert advice on how to craft agreements that will meet requirements — and protect you.

In theory, a medical device supplier quality agreement is a relatively simple document — a written agreement between a client and supplier detailing responsibilities and quality expectations.

However, with globalization and product passing through many different hands, supplier quality agreements need to be ironclad documents assuring critical details don’t fall through the cracks. 

Be warned: Quality agreements are now required by EU GMPs and by various international regulations. The FDA requires them under the FDA Globalization Act of 2009 — and the agency already expects incoming supplies used in production of regulated products to meet GMP requirements.

Make sure your agreements provide all the protection you need. Join industry expert Dan O’Leary on Thursday, May 20, 2010, for the 90-minute webinar — Medical Device Supplier Quality: A Step-By-Step Guide to Creating Ironclad Agreements — and learn:

  • Actual contract language that must be included in every agreement
  • How to draft agreements that address expectations of both you and the supplier
  • Those “minor” details that turn out to be major when problems arise
  • Various agreement formats, with strengths and weaknesses of each
  • “Time bomb” language — what not to include in agreements
  • Dealing with overseas firms — legal, cultural and language problems
  • How to integrate QSR requirements into supplier quality agreements
  • What 5 requirements should be included in all change control requests
  • And much more!

EXCLUSIVE WEBINAR BONUS: Attendees will receive a copy of Dan O’Leary’s exclusive Medical Device Quality Agreement Template.  Worth the price of admission alone, it’s yours FREE with your paid registration!

Like every FDAnews webinar, Medical Device Supplier Quality is convenient to attend. All that’s required is that you be in front of a screen at the appointed time, whether you’re at the office or telecommuting from your office-in-home.

Of course, Mr. O’Leary will be on hand to answer all of your questions. Simply submit your questions via email, and you’ll have answers by the time the session ends.
Everyone in your organization with a role in supplier agreements deserves to take part in this event — and they can do so at a cost that won’t break the budget. You pay a single low registration fee per facility, regardless of how many participate. So spread the word.

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  • Manufacturing
  • Operations
  • Materials management
  • Packaging and labeling
  • Plant engineering
  • Purchasing
  • QA/QC
  • Regulatory affairs
  • Legal counsel

Phone: toll free (888) 838-5578 (inside the U.S.) or +1 (703) 538-7600

Dan O’Leary has more than 30 years’ experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices and clinical labs. Mr. O’Leary is now president of Ombu Enterprises a consultancy focused on operational excellence and regulatory compliance serving small manufacturing companies. He has a master’s degree in mathematics; is an ASQ-certified biomedical auditor, quality auditor, quality engineer, reliability engineer, and six sigma black belt; and is certified by APICS in resource management.

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