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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