Integrated Risk Management and Medical Device QMS - Are You Ready For Increased Regulatory Scrutiny? (Pharmaceuticals Trai)

Venue: Sheraton DFW Airport Hotel

Location: Palo Alto, California, United States

Event Date/Time: Jun 13, 2011 End Date/Time: Jun 14, 2011
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This training covers the essential elements of a medical device quality management system involved in creating an effective Risk Management system. Using the GHTF guidance document for a framework, the seminar covers the QMS essentials (ISO 13485 & QSR) that have the most direct impact on Risk Management. These QMS activities include product planning, design and development, supplier management, process validation, customer complaints, internal quality audits, corrective action, preventive action, and post-market surveillance. In addition, the seminar clarifies the requirements for verification and validation. The material compares and contrasts ISO 13485 and FDA QSR requirements.

ISO 14971 specifically covers Risk Management activities for medical devices. This standard, recognized by the EU, Canada, and the US, provides the structure for Risk Management. The seminar takes the participants through the requirements of the standard with a focus on both effective implementation and integration into the QMS. Participants will learn the skills from establishing a risk matrix for your product to implementing post-surveillance monitoring. The seminar discusses tools for Risk Management including: FMEA (Failure Modes and Effects Analysis), FTA (Fault Tree Analysis, and HACCP (Hazard Analysis and Critical Control Points).

Topics include the Risk Management elements of the US, EU, and Canadian regulatory systems. These include risk classification for medical devices, complaint management, and adverse event reporting. In addition, the training discusses the Global Harmonization Task Force (GHTF) guidance document, Implementation of Risk Management Principles and Activities within a Quality Management System.

NOTE: Use This Promocode ( 117660 ) To Get 10% Discount.


2600 E. Bayshore Road
Palo Alto
United States