What Need To Be Done During An FDA Inspection?

Location: Attend Live Webinar
Date: 13^th – FEB -2015: 10:00 AM PST
Duration : 60 Mins

Speaker: David Lim

Dr. David Lim, Regulatory Doctor, obtained his Ph.D. in biological sciences at the University of Missouri-Columbia and published his thesis research in the prestigious journal “Science.” Since then, he has held various positions at Duke, Caltech, US National Laboratories, Intrexon Corporation, Terumo, US FDA/CDRH, and EraGen Biosciences. 

Course Description:

This presentation is intended to help both medical device and pharmaceutical industry get familiar with the “Best Practices” for what to do during an FDA inspection so that a firm can adequately prepare for and act during the FDA inspection.

Course Objective:

This presentation discusses practical, actionable, and sustainable guidance on how to actionably engage in and communicate including Dos and Don’ts, in particular, during the inspection.   

This presentation will provide great opportunities to become familiar with the best practices for what to do during the FDA inspection.

The speaker will share his practical perspectives for you to consider and greatly improve your process of hosting an FDA inspection.

Course Outline:

·  Applicable Laws and Regulations
·  FDA Guides and Manuals
·  FDA Inspection Logistics
·  Inspection Types, Categories and Classification
·  FDA Forms 482, 483 and EIRs
·  FDA Inspection Preparation and Management
·  Effective Communication During an FDA Inspection: Dos and Don’ts
·  Close Out Meeting
·  Responding to 483s, If Issued
·  Emotional Intelligence-based Approaches
·  Common Mistakes and How to Avoid Them
·  Best Practices to Prevent Common Mistakes in 483s
·  Best Practices for Achieving Compliance and Staying Compliant
·  PASS-IT Suggestions and Recommendations
 
Target Audience:

·  Medical Device Quality and Compliance Professionals
·  Pharmaceutical Compliance Professionals
·  Quality
·  Regulatory Affairs
·  CEOs
·  VPs
·  Attorneys
·  Clinical Affairs
·  R&D
·  Consultants
·  Contractors/Subcontractors
·  Anyone Interested in the FDA inspection Process (Pharmaceuticals)

Please Click hear for More  Information

To Enroll for This Program today  please click hear

Thank you & Regards,

Kevin Roberts,

Training Manager,

kevin.roberts@complianzworld.com

Call us at this Toll Free number: +1-866-978-0800

http://www.complianzworld.com