June 15, 2009 - Design Control, FDA & ISO 2009

FDA & International Consulting and Training Services

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Balboa Peninsula in Newport Beach

Design Control, the FDA & ISO 2009

Training SeminarDownload brochure

• • • Date: Monday, June 15, 2009
    • Location: Paradise Pier Hotel, Disneyland Resort; Anaheim, California USA

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• • • How to comply with FDA’s requirements for Design Control.
    • What FDA expects and will request from you during your Design Control Inspection.
    • What is required in a Design Control process to meet FDA GMP/QSR, ISO 13485 and ISO 9001 regulations, FDA Guidance and concepts for implementation.
    • FDA’s required Design History File (DHF), its content & level of detail.
    • How to overcome the biggest problems in implementing Design Control.
    • How to implement Design Control and Design Reviews that shorten the development cycle rather than waste time and create internal friction.
    • Understand implication of ISO 13485 implementation and revisions to your Design Control process.
    • Ability to pass a Design Control Inspection by FDA
    • Compliance with FDA GMP/QSR, ISO 13485:2003, ISO 9001 requirements
    • Preparation for FDA Investigator questions during a Design Control Inspection
    • Reduced threat of Design Process related Enforcement Actions
    • Shortened product development time, better, and safer products through a well managed Design Control Process
    • Minimized Product Liability risks
    • More rapid 510(k), PMA, IDE, CE Mark submission approvals
    • How Design Control is used in a Special 510(k)
    • Prepare for the Design Control requirement for IDE submissions.
    • A. Introduction to Design Control, Design Control Flowcharts
    • B. Latest FDA regulations for Design Control & FDA Guidance Documents
    • C. FDA’s Small Entity Compliance Guide- implications for Design Control
    • D. ISO 13485:2003 and International requirements for Design Control
    • E. FDA & ISO Design Control Elements-regulation, guidance, & real world
    • F. Design History File (DHF): what is required and how to construct
    • G. When do you start Design Control & who should be the players
    • H. How to schedule & implement Design Control elements and reviews
    • I. The Design Review Process & Design Review SOP Template
    • J. Assessing your process to avoid or eliminate roadblocks during development
    • K. Human Factors Guidance Documents, FDA expectations & impact
    • L. How to develop and maintain your Design Control Lifecycle & Process
    • M. FDA’s Inspection of Design Control Subsystems -How to prepare
    • N. Avoiding problems during an FDA Design Control inspection
    • O. Review & Summary

  Overview:

  FDA investigators are inspecting and pursuing enforcement activities for non-compliant Design Control violations. FDA found and has published that 68% of firms inspected had potential design control deviations. As one of the four major subsystems within FDA’s QSIT inspection program, expect your Design Control System to be inspected. Warning letters published repeatedly cite Design Control deficiencies. Design Control is also a very important element of ISO 13485:2003 in which non-compliance can result in the risk of losing your CE Marks and therefore the ability to market your devices internationally. This program discusses Design Control, the regulatory requirements (U.S. & International), and methods for implementing and maintaining a successful Design Control process. Design Control Flowcharts will be provided to assist with modeling of Design Control procedures and the implementation of an efficient Design Control program. This course is applicable to R&D and RA/QA personnel who are responsible for their company’s Design Control program. It is very beneficial for R&D engineers, QA engineers, RA, Management, Marketing, and Manufacturing personnel who participate in the design control process or may be members of a design team.

  What you will learn:

  Benefits of Attending:

  Abbreviated Outline:

  Speakers: David MacKenzie, Ray Pizinger, Dennis Rubenacker