June 18, 2009 – Software Verification & Validation Strategies 2009

FDA & International Consulting and Training Services

Software Verification & Validation Strategies 2009

(includes Part 11 update)

Training SeminarDownload brochure

• • • Date: Thursday, June 18, 2009
    • Location:Paradise Pier Hotel, Disneyland Resort; Anaheim, California USA

• • • Software Verification & Validation requirements of the FDA and ISO.
    • The latest FDA Software Guidance Documents-impact on V&V strategies.
    • Current thinking on 21 CFR Part 11 and electronic recordkeeping.
    • How to determine an appropriate V & V strategy.
    • Manufacturing software requirements for V & V.
    • How to determine & handle software for different Levels of Concern.
    • What is required for 3rd Party software-custom and Off-the-shelf.
    • What to look for during software vendor audits.
    • V & V documentation and level of detail required for device submissions.
    • Case studies-Devices (different levels of concern), Manufacturing, QC/RA software, Quality System software, 3rd Party, sub-contracted & OTS software.
    • Preparation to comply with FDA GMP/QSR and ISO V & V requirements.
    • 510(k), IDE, PMA, CE Mark submission delays minimized due to software issues.
    • Cost and time savings by implementing the most efficient V & V strategy.
    • Reduced product liability and recalls through manufacturing and device software Verification & Validation.
    • Prepare for a Design Control, Manufacturing or Preapproval FDA inspection.
    • Understand how to handle previously released software.
    • A. Software V & V requirements of FDA GMP & ISO 13485:2003
    • B. Software V & V requirements of the latest International Standards & FDA Software Guidance Documents
    • C. 21 CFR Part 11 Update, Electronic Recordkeeping & Signatures V&V Strategy
    • D. Verification and Validation Definitions
    • E. Verification & Validation Examples
    • F. Software Hazard Analysis
    • G. Levels of Concern and how to determine
    • H. V & V for Minor, Moderate, and Major Concern Devices or Processes
    • I. Verification and Validation Plan- SVVP Template & Specifics
    • J. Software Standard Operating Procedures related to V&V
    • K. Software Quality Assurance Planning -SQAP Template & Specifics
    • L. Software Test Strategies & Methodologies
    • M. Requirements Validation
    • N. Retrospective V & V for Previously Released Software
    • O. Case Studies & Workshop
    • P. Review & Summary

  Overview:
  Software Verification and Validation (V&V) is an extremely important requirement for ensuring the safety and reliability of software used in manufacturing, devices, design, and quality systems. U.S. FDA and ISO 13485:2003 both require Software Verification & Validation. The FDA Quality System Regulation (21 CFR Part 820) states “Design validation shall include software validation and risk analysis.” All devices automated with software will be subject to this regulation. FDA has released a revised guidance document on software which impacts medical device manufacturers. This course will help you understand software verification and validation and the impact of these new revisions on software used by medical device manufacturers. FDA has cited numerous companies on software verification and validation issues in Warning Letters and inspectional observations. This course will discuss what you need to do to comply with FDA and ISO without going overboard by being excessively compliant.

  This course will discuss methods and strategies for applying the most appropriate V & V strategy for a wide variety of software used by medical device manufacturers; thus, saving considerable time and money. This course will provide an understanding of the software V&V strategies for Manufacturing Software, Device Software & Submissions, 3rd Party & off-the-shelf (OTS) software, QC/RA statistical, Quality System, & clinical software. Case studies will be presented to facilitate the discussion. SVVP, SQAP and OTS Templates will be provided.

  What you will learn:

  Benefits of Attending:

  Abbreviated Outline:

  Speaker: Marc Goodman, Dennis Rubenacker