OVERVIEW: THIS WEBINAR IS INTENDED TO HELP YOU GET 2012 - Current Good Manufacturing Practice for Medical Devices Including IVDs - Webinar By GlobalCompliancePanel

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Category Online Training,Medical Devices ,IVDs, Manufacturing,CAPA,DMR,Audits

Deadline: November 27, 2012 | Date: November 27, 2012

Venue/Country: Wilmington, U.S.A

Updated: 2012-10-16 21:35:47 (GMT+9)

Call For Papers - CFP

Understanding quality system regulations and requirements can significantly contribute to achieving compliance fast, resulting in saving significant amount of time and efforts and bringing quality and innovative medical products to the market faster. This webinar will discuss Quality System (QS) regulations, requirements and compliance. At the end of the webinar, you will get familiarized with the current Good Manufacturing Practice (cGMP) for medical devices including in vitro diagnostic medical devices.

At the end of the webinar, you will leave empowered in that you would take or choose to take different approaches when exercising your judgment and discretion.

Why Should You Attend: All medical devices are subject to good manufacturing practices. This webinar is intended to help you get familiar with the current Good Manufacturing Practice (cGMP) for medical devices including in vitro diagnostic medical devices.

Areas Covered in the Session:

Overview and review of the US QSRs for medical devices

Flexibility of the QSRs

Definitions

Quality system requirements

Management responsibility

Audits

Personnel

Design control

validation, design transfer, and design changes

Design history file (DHF) and device master record (DMR)

Quality system procedures

Purchasing controls

Inspection, measuring and test equipment

Process validation

Corrective and preventive action (CAPA)

Complaint files

Servicing

Quality requirements for premarket approval (PMA) application

Enforcement actions: case studies

Lessons learned

Who Will Benefit:

CEOs

VPs

Compliance officers

Attorneys

Clinical affairs

Regulatory affairs

Quality assurance

R&D

CROs

Consultants

Contractors/subcontractors

Dr. 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, Dr. Lim has held various positions at Duke, US National Laboratories, Intrexon Corporation, Terumo, US FDA/CDRH, and EraGen Biosciences, Inc., A Luminex Company. In 2009, Dr. Lim served as a member during the FDA’s Transparency Public Meeting. Prior to founding his own consulting firm (www.RegulatoryDoctor.com), Dr. Lim was Senior Vice President of Scientific and Regulatory Affairs at Aquavit Pharmaceuticals, Inc. in New York, wherein Dr. Lim provided inspiring and actionable solutions for sustainable business operation. Dr. Lim as 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. Over the years, Dr. Lim has analyzed over 1,000 FDA warning letters. Dr. Lim has also attended more than 50 FDA Advisory Panel Meetings and analyzed the subject matters and decision-making processes in detail. Dr. Lim is familiar with more than 200 medical products (medical devices including 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). Dr. Lim is an auditor, regulatory coach, consultant and instructor for global matters pertaining to regulatory affairs and compliance, quality and clinical affairs.

Webinar By GlobalCompliancePanel

Price List:

Live : $245.00

Corporate live : $495.00

Recorded : $295.00

Phone: 800-447-9407

Fax: 302-288-6884

webinarsglobalcompliancepanel.com

http://www.globalcompliancepanel.com

1000 N West Street | Suite 1200 | Wilmington | DE | USA | 19801