Best Practices to Prepare FDA Inspections

Start Date : July 10, 2018
End Date : July 10, 2018
Time : 10:00 am to11:30 am

Phone : 800-447-9407
Email : support@compliance4All.com

Location :
161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA

Website

Description

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

Organized by

Organized by compliance4all14

Event Manager ,
161 Mission Falls Lane, Suite 216,

Compliance4All is a professional trainings provider for the regulated industries. It offers professional trainings for regulatory compliance professionals and offers innovative strategic consulting and advice to a broad range of organizations. These services help them to be compliant with regulatory requirements.

Tel: 800-447-9407
Mobile: 8004479407
Email: support@compliance4All.com
Website: http://www.compliance4all.com/


Event Categories: Health & Nutrition.

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