Managing and Reducing Drug and Device GxP Deviations: The Complete Guide to Successful Failure Investigations
Product Details
GxP deviations ... The moment you discover one, doubts set in. What's your next step? Who must be notified, and how? Will a failure investigation really uncover the root of the problem? And that CAPA — how do you know it's the right one?Now FDAnews and MHP Consultants are offering an interactive workshop that answers all these questions and much more ... AND gives you the tools you need for full compliance with FDA and international regulations on managing and reducing GxP deviations — over the entire investigation life cycle.
At Managing and Reducing Drug and Device GxP Deviations workshop, you will discover how to:
- Spot deviations quickly and accurately (exclusive data checklist!)
- Interview your employees and question corporate processes with field-tested tips that really work
- End "feel good" investigations: Apply expert techniques to expose root causes
- Choose the right investigator to lead your strategy meetings (so you never fall prey to this common investigation pitfall)
- Keep your strategy meetings productive using proven tricks of the trade
- Analyze — and challenge — CAPAs to choose the best action every time
- Decide what you should (and shouldn't) include in your investigation report
- Craft and present a comprehensive "investigation package" that both employees and executives will use
From enterprise-level companies to the smallest start-up, no firm is safe from GxP deviation warning letters, including yours. Protect your investigation from start to finish: Register for this attendee-focused workshop today!
Exclusive Attendee-Focused Workshop
Unlike the one-size-fits-all workshops that you may have attended, Managing and Reducing GxP Deviations is built around you.
Here's how it works. Fill out the exclusive pre-workshop survey (you'll receive it once you register) for two days of:
- Hand-picked investigation case studies best suited to your situation
- Targeted breakout sessions geared toward your GxP skill set
- Instant rapport with expert presenter Michele Piepoli — she'll have reviewed your "GxP trouble spots" before you meet!
- And much more
Bottom line? For targeted material ... top value ... and true networking, sign up for Managing and Reducing GxP Deviations — the workshop that's focused on you.
Your valuable course materials book is packed with tools and reference data you can put to use right away, including:
- Slides from PowerPoint presentations
- Case review worksheets
- Interactive exercise worksheets
- Checklist of key elements in preliminary investigation
- Checklist for data gathering
- Investigation report template
- Notification of a deviation template
- Reference
documents:
- FDA guideline for handling of out-of-specification test results
- CFR 210-–211
- CFR 820
- ISO 13485