The Online Seminar shows the Possibilities of the use of Desktop-Sharing Software. The Online-Seminar is free of charge an will contain the following topic.
How to Setup the Software.
The Webinar will held on request, the duration is approx. 30 Minutes
Further Information to the Online-Seminar
Allan Gonsher and Kids Inc are pleased to a offer a series of Play Therapy Webinars. If your work with children, or want to work with children, these are workshops that you can not afford to miss. Each webinar workshop offers one hour of continuing education credit.
CE Marking for Medical Devices Including In Vitro Diagnostic Devices - Webinar By GlobalCompliancePanel
Start: 08/09/2012 10:00 am
Overview: This webinar is intended to help you get familiar with the European Union (EU) Directives governing medical devices including in vitro diagnostic medical devices and active implantable medical devices. This webinar is further intended to provide guidance on the regulatory requirements set forth 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 and CE marking process.
This webinar will help you profoundly change your way of regulatory and quality planning, development, and execution.
Why should you attend : To place your medical device products on the EU market, they must meet the requirements set forth in the applicable Directives.
This webinar will walk you through to help you understand the EU regulations governing medical devices including active implantable medical devices and in vitro diagnostic medical devices.
If you are engaged in global marketing of your medical products in EU, it is a must to attend this webinar.
Areas Covered in the Session
Who Will Benefit:
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.
Start: 08/09/2012 10:00 am
Overview: This webinar covers the fundamentals of 21 CFR Part 11, software validation, and computer system validation. It provides details for company compliance including GAMP, qualification, and validation. It teaches the Part 11 industry standards for SOPs, security, data transfer, audit trails, and electronic signatures. The webinar details the common problems and how to avoid them.
Areas Covered in the Session:
Who Will Benefit:
David Nettleton, is an FDA Compliance Specialist for 21 CFR Part 11, HIPAA, and Computer System Validation. His latest book is "Risk Based Software Validation - Ten easy Steps" that relates to the development, purchase, installation, operation and maintenance of computerized systems used in regulated applications. He specializes in performing gap analysis, remediation plans, SOP development, vendor audits, training, and project management. He has completed more than 185 mission critical software validation projects.