COURSE "CURRENT GOOD MANUFACTURING PRACTICE FOR ME 2013 - Current Good Manufacturing Practice for Medical Devices Including IVDs - Webinar By GlobalCompliancePanel

Website http://bit.ly/V8Xkk7 | Edit Freely

Category Medical Device, Pharma, Biotech, Clinical, Drug, Food Safety, Helth

Deadline: January 31, 2013 | Date: January 31, 2013

Venue/Country: California, U.S.A

Updated: 2013-01-18 16:33:06 (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.

GlobalCompliancePanel

Price: $225.00

Phone: 800-447-9407

Fax: 302-288-6884

webinarsglobalcompliancepanel.com

http://www.globalcompliancepanel.com

http://bit.ly/V8Xkk7