Best Practices to Prepare FDA Inspections

MessageThis Webinar is over
Date Jul 10, 2018
Time 10:00 AM to 11:30 AM
Cost $ 150.00
Online
Overview:
It will also provides the challenges from the results of an inspection, in preparing and managing an inspection, and the benefits of successful results from an FDA inspection.

Why should you Attend:
This course is designed to provide participants with an understanding of the purpose of FDA Inspections, the consequences of not complying with their requirements and how to prepare and manage these types of inspections. It will provide details on each topic from the course outline.

Areas Covered in the Session:
Purpose of FDA Inspections
How Does FDA Decide Who to Inspect
Inspection Frequency, Relationship to PMAs/NDAs/BLAs and Reference to the Inspection Model
FDA Enforcements
Example of DOJ Pharma/Device Settlements

Who Will Benefit:
Quality Auditors
Compliance Officers
Executive Management

Speaker Profile:
Vanessa Lopez - Sr. Principle Quality, Regulatory and Compliance Consultant. She has held a wide variety of leadership roles in the Medical Device (Class: I, II, and III), Pharmaceutical (API; Finished Product) and Environmental regulated industries as well as the Consulting Services industry. She has worked for Edwards LifeSciences, Roche Diagnostics, Eli Lilly and Company, Pall LifeSciences, among others.

Event Fee: One Dial-in One Attendee Price: US$150.00

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: support@compliance4All.com

 


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