EUROPEAN UNION (EU) DIRECTIVES GOVERNING MEDICAL D 2013 - Do You Know CE Marking: MDD, AIMDD, and IVDD - Live Webinar

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Category Biotechnolgy ; Pharma

Deadline: March 11, 2013 | Date: March 12, 2013

Venue/Country: Houstan, U.S.A

Updated: 2013-02-08 21:37:59 (GMT+9)

Call For Papers - CFP

This webinar is intended to help you get familiar with the European Union (EU) Directives governing medical devices including in vitro diagnostic and active implantable medical devices. This webinar is further intended to provide guidance on the regulatory requirements set out in the applicable Directives, which help assure that medical devices are safe and effective for their intended use.

Understanding the EU regulatory and quality requirements can significantly contribute to meeting the requirements and achieving compliance fast, resulting in saving significant amount of time and efforts and bringing innovative medical products to the EU market faster.

This webinar will discuss EU Directives, requirements and compliance. At the end of the webinar, you will get familiarized with the applicable EU Directives governing medical devices including in vitro diagnostic and active implantable medical devices.

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

Why you should attend

This webinar is intended to help you get familiar with the European Union (EU) Directives governing medical devices including in vitro diagnostic and active implantable medical devices for CE marking purposes.

Areas Covered In the Seminar

How EU laws are made

Overview of European Medical Device Regulations and Regulatory Framework for Medical Devices

Medical Device Directive (MDD)

Active Implantable Medical Device Directive (AIMDD)

In Vitro Diagnostic Device Directive (IVDD

2007/47/EC amending MDD and AIMDD

CE marking principles

ISO 13485, ISO 14155, and ISO 14971

GHTF and MEDDEV guidance documents

Who will benefit

? CEOs

? VPs

? Compliance officers

? Attorneys

? Clinical affairs (associates, specialists, managers, directors or VPs)

? Regulatory affairs (associates, specialists, managers, directors or VPs)

? Quality assurance (associates, specialists, managers, directors or VPs)

? R&D (engineers, scientists, managers, directors or VPs)

? CROs

? Consultants

? Contractors/subcontractorsProduct and development (associates, scientists, managers, directors and VPs).

? Marketing (associates, specialists, managers, directors and VPs).

? Site managers, and consultants.

Contract manufacturing organization (associates, scientists, managers, directors and VPs)

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 : F62210

Schedule Date :

Tuesday, March 12, 2013

duration : 11:00 to 12:00 PM EST

https://compliance2go.com/index.php?option=com_training&speakerkey=27&productKey=184