Survival Strategies for Successful Pharmacovigilance InspectionsPrepare, Participate ... and Successfully Close!
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FDA has new money budgeted for these crackdowns, known officially as the “Postmarket Adverse Drug Experience Inspectional Program.” And it’s not just U.S. companies facing the pharmacovigilance cops. Health Canada, for instance, is reported to be tacking pharmacovigilance inspections on the end of traditional GMP inspections.
In a fast-paced 90-minute Encore presentation, you and your staff will glean essential guidance on preparing in advance for pharmacovigilance inspections ... how to manage the investigation itself ... and most importantly, how to bring the matter to a close with no nasty aftershocks — such as 483s, warning letters ... even seeing clinical trials suspended and drugs pulled from market when violations are serious enough.
Pharmacovigilance investigators are likely to shine the spotlight without warning on staff who’ve never dealt with inspections too. Make sure your “newbies” are on hand for tips, advice and guidance on how to deal with these inspections. It could save your organization time, hassles — and actual dollars.
You and your entire staff will get the answers you need to pressing questions such as:
- How do you determine whether the information you’re giving investigators is too little ... or too much?
- How do you tailor SOPs specific to pharmacovigilance departments to pass inspections with flying colors?
- How do pharmacovigilance inspections differ in the U.S., Canada and Europe?
You’ll discover:
- 10 tips for conducting internal audits
- 3 top corrective actions that follow pharmacovigilance inspections
- 6 deficiencies that turn up most often during inspections
- 7 criteria the FDA uses when deciding which firms to inspect first
- And much more!