I'll be presenting a webinar and taking your questions on Wednesday, July 14th through ExpertBriefings.com.
The title of my talk: Supplier Quality Toolkit - How to Put in Place a Proven, Risk-Based Supplier Qualification and Monitoring Process that Meets FDA Compliance and Saves Money
Here's the high-level agenda:
- Requirements for supplier oversight
- Four core components
- Toolkit walkthrough
Examples of the practical challenges I'll tackle include:
Firms cannot justify spending more to evaluate, qualify, and monitor than the expected expenditure on the supplied material or service. If the average onsite qualification of a critical supplier costs at least $9,000-14,000 a year, and yet you plan on doing less than $10,000 worth of business with them, how do you proceed?
And how do you handle suppliers who don't care about meeting FDA requirements? Perhaps your percentage of their business is simply to tiny to justify the cost of all these controls you're asking them to put in. What to do?
As part of the webinar, I'll present a lean FDA compliance strategy that not only has worked over a number a years, but it has the added benefit of meeting ISO, EMA, and Health Canada expectations. I'll close by showing how the strategy "closes the loop" and helps regulatory affairs and quality management personnel show direct benefit to a company's bottom line.
And, of course, attendees will receive a trial subscription to my SmarterCompliance newsletter along with some other freebie downloads. If you'd like to register, please visit the ExpertBriefings website at http://www.ExpertBriefings.com.
Hope to hear from you on the call, and please let me know if you've signed up - drop me a line!