Boston Professional Events List


2 Days Workshop:FDA Penalties for Regulatory Non-Compliance in the Pharmaceuticals Industry - 2017 in Review


Date
Jan 30, 2018 - 08:00 AM - Jan 31, 05:00 PM
Organizer
conference Manager
Venue
San Diego CA
Location
Homewood Suites by Hilton San Diego-Del Mar, 11025 Vista Sorrento Parkway, San Diego CA 92130.

San Diego,
California,
US,
ZIP: 92130
Phone: 858.720.9500

Ticket Price: Price - Seminar One Registration - $ 1295 Special Group Discount Register for Four attendees - $ 3885

Description

This hands-on seminar provides a comprehensive approach to learning how to proactively prevent non-compliance. There will be intensive reviews on the negative consequences of receiving regulatory enforcement actions. FDA Warning Letters are posted publicly on the CDER web site. Your competitors, shareholders, the public and your patients now become aware of your shortfalls. Many Warning Letters today mandate the hiring of third party consultants, which can be quite expensive. An Injunction will require pharmaceutical companies to spend millions of dollars and require years until you “bounce back.” Multimillion disgorgement penalties are being levied along with Injunctions. 
 

Areas Covered

•    Introduction and Background
•    Summary and Highlights of 2017 Enforcement Actions
•    Penalties and Negative Financial results of Enforcement Actions
•    ICH Guidelines on Quality Risk Management
•    Adequate Responses to FDA
•    Change in Attitude and Culture
•    Metrics on Improvements

 

Who will Benefit

•    Drugmakers
•    Devicemakers
•    Biologics firms
•    Diagnostics firms
•    Executive suite
•    Manufacturing/GMP
•    QA/QC
•    Regulatory affairs

 

Learning Objectives

This 2 Days Workshop is intended for professionals in the 
•  Pharmaceuticals
•  Biotech
•  Medical Device
 



Speaker Details


Know Your Speaker

Brian G. Nadel, RACPresident of Brian G. Nadel, GMP Consulting, LLC
Brian G. Nadel is the President/Sole Proprietor of Brian G. Nadel, GMP Consulting, LLC. He has over twenty-five years of diverse experience in: Pharmaceutical Quality Assurance and Quality Systems; FDA Pre-Approval and Inspection Readiness Inspections; International CGMP Auditing for finished drug products, Active Pharmaceutical Ingredients, Fermentation, Process Validation and botanical extraction.


 

Event Categories
Keywords: pharmaceutical , FD




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