2-DAY QSR/QMS Requirements Training for the Medical Device Industry, April 28-29, 2010

March 8, 2010 - PRLog -- QSR/QMS REQUIREMENTS TRAINING for the Medical Device Industry

Compliance with FDA’s Quality System Regulation is a pre-requisite for marketing medical devices in the United States.  Compliance with ISO’s 13485 Quality Management System standard is essential for global expansion.  QARA Compliance Connection’s 2-Day QMS Requirements Training course was designed for medical device manufacturers looking to gain a thorough understanding of the quality management requirements required for compliance both domestically and internationally.

Interactive discussion and group exercises have been incorporated into the training program in order to provide participants with the opportunity to apply concepts learned to real-world situations, thereby resulting in training that is both comprehensive in theory and application.  

Course Highlights:
•   Basic Review of US, Canadian and European Regulatory Requirements
•   An Introduction to QMS standards and regulations
•   ISO’s Process Approach to QMS Compliance
•   FDA’s Quality System Inspection Technique
•   Reasons for and Benefits of Compliance
•   Key Terms and Definitions
•   In-Depth Review of QMS Requirements
•   How to Conduct a Risk Assessment
•   Methods for Conducting Root Cause Analysis and Determining Effective CAPA
•   Typical FDA 483 Observations/ISO 3rd Party Nonconformances
•   Typical Auditor/Inspector Questions
•   Tips for Compliance with the Requirements
•   FDA Enforcement Options/Actions and Examples
•   Receive a course binder complete with slides, templates, forms, etc.
•   Interact with colleagues and participate in interactive exercises

Instructor:  Marie Teixeira is president and founder of QARA Compliance Connection and has over 20 years experience working in the regulated industry.  Marie served as a member of the international CEN/TC257/SC-DETG10 Task Force responsible for standardizing global medical device nonmenclature. She co-authored a book titled “Design Controls for the Medical Device Industry” as well as published various handbooks; and has developed over a dozen quality system related training modules.  

If you’re looking for a course taught by someone who has lived and breathed quality management systems for over twenty years, this course is for you.  Marie Teixeira understands compliance from the manufacturer’s perspective as well as from the auditor’s perspective.  She has been responsible for successfully implementing and maintaining quality management systems to FDA, Canada and European requirements for numerous companies and been on the receiving end of many FDA inspections and 3rd Party Notified Body audits.  Being an RABQSA Registered Principal Auditor, she has also performed countless audits to FDA’s QSR and ISO’s 13485 quality management system standard.

Who Will Benefit:  This training course is ideal for those individuals responsible for complying with the regulations as well as those individuals involved in the development, implementation, auditing and maintenance of a company’s quality management system.

Register:  Don’t wait until you receive an FDA 483 or fail an ISO audit to become knowledgeable and compliant with the regulations.  Register today and stay ahead of the game!  Register by March 28th and receive $100 off the $995 registration fee.

For more information or to register online, contact QARA Compliance Connection, Inc at:
Tel (813) 784-8457
Email: info@qaracc.com
Info:  www.qaracc.com/seminars.html
Register: www.qaracc.com/reg.html