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« Monday June 04, 2012 »
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Online Seminar Software 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. Cost of the Software Usage in the Sales and Marketing area. The Webinar will held on request, the duration is approx. 30 Minutes Further Information to the Online-Seminar Business Mastery Series Learn more: www.practicepaysolutions.com/mastery Join us for a free series of one-hour webinars with the a team of industry experts! We're presenting the less-covered, critical issues for small business owners, so you can reduce the time you spend on set-up and administration-- and focus on what really matters. Can't attend live? We'll send you the call recordings so you can access valuable information and share the event with your community! April 2nd: The Joy of Productivity with George Kao April 16th: How to Create Profitable Referral Partnerships with Robert Notter April 24th: Say Bye-Bye to Your Boring Bio with Nancy Juetten May 15th: From Contacts to Contracts with Caterina Rando May 22nd: Red Fire Profitability with Liz Goodgold June 5th: Developing Contracts & Service Agreements with Tasha Cooper Coleman June 19th: Outsourcing Secrets with Travis Greenlee July 10th: Your Money Relationship = Your Business Success with Helen Kim July 24th: How to Play a Bigger Marketing Game with Fabienne Fredrickson Play Therapy Webinar Series 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. Live webinar on Medical Devices: EU Directives, Guidance Documents, CE Marking Process and ISO Certification Programs By Compliance2go Start: 06/04/2012 12:01 pm End: 06/04/2012 12:02 pm Why Should You Attend This webinar is focused on understanding the requirements of the Medical Device Directives, their linkage to the EU Clinical Trial Directive and the requirements of CE Marking and ISO Certification on commercializing products. The course covers all relevant topics in brief associated with the Directives and Guidance Documents, the reasons behind their introduction and a review of methods for effective implementation. Key Topics to be Discussed: The current regulatory situation in relation to Medical Devices in the EU. The purpose of the Medical Device Directives. Meeting the New Requirements for Conformity Assessment by Product Type. Understanding the impact the Directive will have on developing and marketing new Medical Device products. An overview of key areas of the Directive: Scope of application and definition Essential Device Requirements Medical Device Type & Process Path Medical Device Technical File Clinical Investigation Requirements Clinical Evaluations Notified Bodies involvement Gain a detailed understanding of all Guidance Documents available to assist in the implementation of these directives. Detailed Agenda of the Session Definition: Medical Device or Personal Protective Equipment. Overview of the Global Medical Device Industry Standard Active Implanted In Vitro Diagnostic Combination Products; Drug or Biologic + Device- Interface with Other Directives and How It’s Treated from a Regulatory Perspective An Overview of the Medical Device Directives. Development, aims, implementation and update of the Medical Device Directives Implication of an EU Directive vs. Regulation Medical Devices (MDD), Active Implanted Medical Devices (AIMDD), In Vitro Diagnostic Medical Devices (IVDMD), Combination Products Update on the additional guidance documents relating to the directives Essential Requirements Classification of MD's and Process Implications Conformity Assessment Technical File Relationship to EU Clinical Trial Directive Guidance Documents. Medical Device Directive Annexes. Compliance Requirements by Type Full Quality Assurance System Declaration of Conformity Safety. Medical Device Vigilance System Manufacturer's Requirements GMP GCP CE Marking ISO Certification Clinical Trials Labeling ISO Standard Certification. Overall process; Management Commitment & Involvement Role of Notified Bodies Relationship to CE Marking ISO-13485 (Manufacturing) & ISO-14155 (Clinical Investigation & Evaluation) Overview, Conformity, Auditing and Harmonization to International Standards ISO-14155 Medical Device Clinical Investigations. Part I- Clinical Studies Part II- Clinical Investigations Linkage to EU Clinical Trial Directive; What Does & Doesn't Apply Compare & Contrast EU & FDA Procedures and Requirements. Process Similarities & Differences Implications for Industry Company Management Process Changes Management Team Effectiveness Regulatory Approval and Liaison with Regulators. EU Co-Decision Procedure Committees, Working Parties Relevant for Medical Devices When and How to Influence Regulators Do's and Don'ts of Regulatory Involvement Individual Company Involvement vs. Trade Association Learning Objectives Upon completion of this course attendees will have a thorough knowledge of the requirements for developing and marketing Medical Devices across the European Union. The Directives are complex and the requirements differ somewhat by Member State. The content of this course is designed to simplify the understanding of all requirements and to provide attendees with the latest information regarding interpretation and enforcement of these regulations. Who Will Benefit This workshop will be of great value to Medical Device professionals and those involved in the registration of Medical Devices across the EU. It is primarily designed to benefit the following disciplines: Clinical research and medical operations Project Managers Product Development personnel Manufacturing personnel Researchers managing Medical Device R&D and Development Quality Assurance such as GMP, GCP Auditors Regulatory affairs Clinical trial supply personnel CRO personnel All personnel who need to understand the procedures and impact of placing Medical Devices on the Market in the EU (30 expanded EEA countries) About Speaker Robert J. Russell, is President and CEO of RJR Consulting, Inc, a leading Global Regulatory Consulting firm focusing on assisting the Life Science Industry. Prior to founding the firm in 2000, Mr. Russell had over 27 years of experience in CMC, Global Business Development and Regulatory Compliance for pharmaceuticals, biologics, medical devices and combination products. The company has an office in Brussels, Belgium where they interact with the European Commission and the Competent Authorities across the EU. Country establishment, marketing authorizations, variations and license renewals are core competencies of the course director. Mr. Russell has received a B.S. and M.S.in Chemistry. Virtual Open House: Bryant & Stratton College Online Start: 06/04/2012 6:00 pm Bryant & Stratton College Online, a premier provider of online Associate’s degree programs, will host a free Virtual Open House on Monday, June 4, from 6:00-8:00pm EDT. Admissions representatives will be available to chat live and answer questions from prospective students about the online degree programs at Bryant & Stratton College Online. Representatives will also give an overview of the overall online college experience from application deadlines, the enrollment process and courses, to career services, opportunities and support available to students. For registration and more information, please visit http://online.bryantstratton.edu/openhouse/