PROVIDE EMOTIONAL INTELLIGENCE (EQ)-BASED PRACTICA 2013 - Live Seminar on FDA Inspection: Preparation and Management

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Category Medical Device ; Biotechnolgy ; Pharma

Deadline: February 27, 2013 | Date: February 28, 2013

Venue/Country: Houstan, U.S.A

Updated: 2013-02-08 20:18:21 (GMT+9)

Call For Papers - CFP

This webinar is intended to help you get familiar with how to prepare for and manage an FDA inspection including dos and don’ts before, during, and after FDA inspection.

Description of the topic :

This webinar is intended to provide emotional intelligence (EQ)-based practical and actionable guidance on how to proactively prepare for a sustainable FDA inspection and how to manage the FDA inspection process including Dos and Don’ts before, during and after the inspection.

This webinar is further intended to discuss and understand FDA’s inspection authority and compliance programs.

At the end of the webinar, you will get empowered in an effective way that you would proactively prepare for and confidently manage the FDA inspection process including the inspection response.

Webinar Includes:

-Q/A Session with the Expert to ask your question

-PDF print only copy of PowerPoint slides

-60 Minutes Live Presentation

- Certificate of Attendance

Areas Covered in the Session:

? FDA Regulations and Authority

? Field Management Directives

? Investigations Operations Manual

? Inspection Guides

? Compliance Program Guidance Manual

? How to Host an FDA Inspection

? Inspection Types and Categories

? Inspection Classification

? Inspection Process

? FDA Forms 482 and 483

? Inspection Response

? What/How to Prepare for and to Manage an FDA Inspection

? How to Communicate Before, During and After inspection: Dos and Don’ts

? Case studies

? Conclusion

Who will benefit: (Titles)

? CEOs

? VPs

? Compliance Officers

? Attorneys

? Regulatory Affairs

? Clinical Affairs

? Quality Assurance

? R&D

? Consultants

? Contractors/Subcontractors

Anyone Interested in the FDA inspection Process

About Speaker

Dr. David Lim 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, US National Laboratories, Intrexon Corporation, Terumo, US FDA/CDRH, and EraGen Biosciences (A Luminex Company). In 2009, Dr. Lim served as a panel member during the FDA’s Transparency Public Meeting. Prior to founding his own consulting firm, Regulatory Doctor, Dr. Lim was Senior Vice President of Scientific and Regulatory Affairs at Aquavit Pharmaceuticals. Regulatory Doctor provides practical, actionable and strategic solutions integrated with emotional intelligence (EQ) skills for all aspects of global regulatory, quality, clinical and compliance matters. Dr. Lim has analyzed over 1,000 FDA warning letters, attended more than 50 FDA Advisory Panel Meetings, and analyzed the subject matters and decision-making processes in detail. He is familiar with more than 200 medical devices, IVD products, biologics, drugs and combination products. Dr. Lim is a certified professional for regulatory affairs (RAC) and also is a certified quality auditor (CQA) by the American Society for Quality (ASQ). He is an auditor, regulatory coach, consultant and instructor for global matters pertaining to regulatory affairs, regulatory compliance, quality and clinical affairs.

Speaker : Dr.David Lim

Product ID : F62209

Schedule Date :

Thursday, February 28, 2013

duration : 11:00 to 12:00 PM EST

https://compliance2go.com/index.php?option=com_training&speakerkey=27&productKey=223