2-day In-person Seminar on “Applying ISO14971:2012 and IEC62304 - A Guide to Practical Risk Management” in Berlin, Germany
October 23 - 24, 2014 - Berlin CA USGlobalCompliancePanel
globalcompliancepanel@gmail.com
Phone:18004479407
Fax:302 288 6884
Summary of the Workshop: Gaps, incorrect or incomplete implementation of safety functionality can delay or make the certification/approval of medical products impossible. Most activities cannot be retroactively performed since they are closely linked into the development lifecycle. Diligent, complete and correct implementation of risk management from the start of product development is therefore imperative. This course will introduce all necessary steps to design, implement and test critical medical devices in a regulatory compliant environment. This course will additionally address the software risk management and the resulting interfaces to device level risk management. To comprehensively summarize all risk related activities and to demonstrate the safe properties of a device the 'Safety Case' or 'Assurance Case' document is a well-established method to collect all safety related information together in one place. This documentation will most likely become mandatory for all devices (currently only required for FDA infusion pump submissions). This course will introduce the basic concepts and content of safety assurance cases and will illustrate the usefulness for internal and external review of safety related information. Learning Objectives: Introduction into Risk Management and Quality System Integration Risk Management to ISO 14971:2012 Usability and Risk Management Software Risk Management (IEC62304 / FDA software reviewers' guidance) Software Risk Management (IEC62304 / FDA software reviewers' guidance) Safety / Assurance case Meet your Expert: Markus Weber is owner and Principal Consultant with System Safety, Inc. He specializes in safety engineering and risk management for critical medical devices. He graduated from Ruhr University in Bochum, Germany with a MS in Electrical Engineering. Before founding his consulting company, he was a software safety engineer for the German approval agency, TUV. Since 1991, Mr. Weber has been a leading consultant to the medical device industry on safety and regulatory compliance issues, specifically for active and software-controlled devices. In conjunction with the FDA, he has published works on risk management issues and software-related risk mitigations. Over the last 25 years Mr. Weber has helped hundreds of companies, from start-ups to Fortune 500 firms, to design safe medical devices. He trained hundreds of professionals on four continents in practical risk management and system safety methodologies. He frequently conducts webinars, in-person seminars, corporate training and he teaches Medical Device Risk Management the University of California Irvine Extension. RAC Credits: 12 Date: October 23rd & 24th, 2014 Event Details: http://bit.ly/PracticalRiskManagement Location: Berlin, Germany Venue: Hilton Hotel Berlin, Mohrenstra 30 10117 Berlin Germany Venue Link: http://www3.hilton.com/en/hotels/berlin/hilton-berlin-BERHITW/index.html Registration: Open Enrollment Delivery: Face-to-Face event Price: $1595.00 Until September 15, Early Bird Price: $1,595.00 From September 16 to October 21, Regular Price: $1,795.00 Audience: Senior quality managers, Quality professionals, Regulatory professionals, Compliance professionals, Project managers, Design engineers, Software engineers, Process owners, Quality engineers, Quality auditors, Medical affairs, Legal Professionals. Course Web Site: https://www.globalcompliancepanel.com/control/~product_id=900117SEMINAR/practical-risk-management_Germany Organizer: GlobalCompliancePanel imparts knowledge of best practices in industry to guarantee effective implementation of compliance programs for meeting regulatory demands. The key focus of GlobalCompliancePanel is to provide extensive and quality training for risk management, regulatory compliances, corporate governance and quality management. Our Achievements: Over 300 Experts that are Renowned in their Respective Areas Successfully Trained more than 20,000 Compliance Professionals A Most Comprehensive Portal for Trainings, Industry Updates and Professional Growth Having more than 2000 Online Courses Successfully Completed more than 170 Seminars in US and Globally Provider: GlobalCompliancePanel John Robinson 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA Phone: 800-447-9407 Fax: 302-288-6884 Email: support@globalcompliancepanel.com Website: www.globalcompliancepanel.com