Supplier Quality Agreements for Warehouses and Shippers: How to Survive the FDA’s Crackdown on Drug Storage Conditions
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In fact, based on their own data, the FDA has called inadequate storage conditions one of the top issues causing recalls.
Think it couldn’t happen to you? Of more than 50 recent FDA inspections of wholesaler warehouses, 17 have resulted in a Form 483.
In its most specific language yet, the FDA says that inadequate storage conditions are one of the leading causes of recalls, based on their own data.
And it’s very clear the agency will continue to put drugmakers on notice, with new Form 483s citing everything from temperature violations to inadequate documentation.
When it comes to shipping and storing drugs and biologics, the toughest purchasing agreements can no longer protect you from product recalls over safety issues.
Today, you need comprehensive quality agreements with your wholesalers, warehouses and shippers. And every minute you operate without them, you’re at risk for enforcement actions.
What should quality agreements say? What’s the smartest way to negotiate terms that will work for the FDA and everyone in your supply chain? And what’s in the regulatory fine print that you need to know to avoid 483s and warning letters?
Don’t miss your chance to learn how to negotiate, draft, implement and audit supply quality agreements that assure compliance with FDA regulations. Plan to attend this FDAnews webinar:
Supplier Quality Agreements for Warehouses and Shippers:
How to Survive the FDA’s Crackdown on Drug Storage Conditions
Jim Darnell, an expert in pharmaceutical quality assurance and regulatory compliance, takes the guesswork out of creating ironclad quality agreements with wholesalers, warehouses and shippers, including:
- From calibration to procedures for holding drugs out of their labeled storage conditions: what specific drug storage issues are triggering today’s recalls
- Tips and tricks to make sure your supply chain vendors know — and meet — your standards for safe, well-documented drug storage and transportation
- How to use your quality assurance agreements to vet, collaborate with and review vendors
- 5 tips for incorporating the SOPs inspectors look for directly into third-party supplier contracts
- How to identify threat/exposure associated with cold chain transit and storage risk elements
- How to use a written drug stability program to avoid 21 CFR 211.166 violations
- Real-world case studies and practical examples of how to avoid losses from spoilage, contamination, and other temperature-driven issues
- And more
Supplier Quality Agreements for Warehouses and Shippers 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, telecommuting or on the road.
As part of the webinar, Mr. Darnell 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 sales, marketing and compliance will benefit from taking 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.