Inspectional Readiness Are Your SMEs Prepared for A Successful FDA Visit?
Product Details
Your SMEs need the same kind of training and rehearsing to fine-tune their FDA investigator playbook.
Sure, you have all the logistics nailed down. But how well prepared is your team to interact with FDA investigators?
In far too many drug and device firms, the SMEs who know the most about front-line operations usually know the least about inspections. They need special training on dealing with investigators – how they operate, what techniques they use, cues they look for during interviews, how they prepare for inspections, their mindsets and motivations.
Fortunately, help is at hand.
SPECIAL BONUS for Attendees |
You’ve got the room, the copies of documents, who’s going to meet the investigator, but are your SMEs prepared to answer the FDA inspector’s questions succinctly and confidently?
For example:
- Does your newly hired quality manager fully understand your processes or quality records, or might he or she be tripped up by a simple question?
- What should an SME say to an FDA investigator if he or she just doesn’t know the answer to a question?
- Are your SMEs aware of your company policies regarding taking photographs, access to internal audit files or other proprietary resources?
In just 90-minutes, have your SMEs and team ready for game time. This webinar can help you turn your 2013 FDA inspection nightmare into a dream!
Don’t have time to listen to the webinar? No problem, Inspectional Readiness is also available in PDF or print. You’ll learn how to train SMEs for Inspection Day through three case studies – based on actual investigations – that show how things operate in the real world.
ONE STOP TRAINING PRODUCT FOR YOUR SMEs For one low price you will get:
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From process owners and engineers to quality, manufacturing, project, operations and validations managers, everyone on your team will benefit from taking part in this event. Best of all, everyone can attend at a cost that won’t break the budget.
Sign up for Inspectional Readiness: Are Your SMEs Prepared for a Successful FDA Visit? today. Please note; this webinar has been previously recorded and no questions will be taken during the presentation.