This webinar is intended to help you get familiar with how to prepare for and manage an FDA inspection in an actionable, sustainable manner with improved awareness. If a firm is subject to FDA regulations, they should be ready for an FDA inspection. This webinar provides “PASS-IT” strategy and strategic plan/planning on your FDA inspection preparation integrated with emotional intelligence (EQ) skills. It is delivered in a way to help you effectively communicate and improve awareness and preparedness for an FDA inspection at all levels of organizations.
This webinar will discuss what you need to be aware and familiar with to get ready for an FDA inspection with confidence. In particular, a list of Dos and Don’ts will be shared and explained for your maximum advantages.
At the end of the webinar, you will become familiar with what and how your firm should get ready for an FDA inspection with improved awareness under your guidance.
Areas to be Covered:
Applicable Statutes and Regulations
FDA Inspection: Scope and Depth
Inspection Types and Categories
Hosting an FDA Inspection
Act with Awareness and Familiarity
Common Questions and Responding to Questions
FDA Forms 482 and 483
Responding to 483: How to Avoid Mistakes
Before, During and After FDA Inspection: Dos and Don’ts
Misconception and Mistakes – How to Avoid
Speaker’s PASS-IT Suggestions and Recommendations
Who will Benefit:
Research & Development Teams
Anyone Interested in the FDA inspection Process