June 17, 2009 - Software, the FDA & ISO 2009

FDA & International Consulting and Training Services Laguna Beach

Software, the FDA & ISO 2009

(includes Part 11 update)

Training SeminarDownload brochure

• • • Date: Wednesday, June 17, 2009
    • Location: Paradise Pier Hotel, Disneyland Resort; Anaheim, California USA

• • • Content & impact of the latest Software Guidance Documents and Standards
    • FDA & ISO policies, guidance & regulations.
    • How to achieve FDA compliance-now and in the future.
    • FDA enforcement actions and consequences due to non-compliance.
    • How to audit software development & automated processes using provided checklists.
    • Impact of the latest IEC 62304 Medical Device Software Standard.
    • How to get and keep your software under control.
    • How to make compliance a by-product of your software development process.
    • Understand the FDA’s current position on Electronic Recordkeeping, 21 CFR Part 11 and what you should be doing to be compliant.
    • What to expect and what will be expected of you in an FDA inspection.
    • Software requirements and guidance for 510(k), IDE & PMA submissions.
    • Preparation for the latest Software Guidance Documents and New Standards
    • 510(k), IDE, & PMA approval delays minimized due to software issues.
    • Software compliance to FDA GMP/QSR/Design Control & ISO regulations.
    • Preparation for FDA to inspect your Electronic Recordkeeping system for compliance to 21 CFR Part 11.
    • Provides means of determining compliance with FDA requirements.
    • Reduced risk of delays, liability, and enforcement actions due to design or manufacturing compliance issues resulting from FDA inspections & ISO audits.
    • Provides information to assess and manage the S/W development process.
    • Provides information necessary to establish software process controls.
    • A. FDA & ISO Regulatory Aspects of Software & Computers
    • B. FDA Software direction for GMP/Design Control/Submissions
    • C. Compliance issues, Enforcement actions, and Submission Requirements
    • D. Software Guidance and New Standards for Software-content & their impact, inc. IEC 62304 Standard
    • E. Update on International software standards and guidance
    • F. Software Life Cycles-various methods & detailed phase discussion
    • G. Software Life Cycle-Requirements/Design/Implementation/Test/ Installation & Checkout/Operation & Maintenance Phase Deliverables
    • H. Software Life Cycle-Standard Operating Procedures & Templates
    • I. Hazard/Risk Analysis/White/Black Box Testing & Traceability
    • J. Verification & Validation and Documentation Outlines
    • K. Software Development Processes for Software Quality Assurance Planning & Controls
    • L. Electronic Recordkeeping and FDA 21 CFR Part 11 overview and update
    • M. How to prepare Software and relevant documentation and what to expect during an FDA Design, Manufacturing, or Pre-approval Inspection
    • O. Auditing device software and automated process software using provided audit checklists
    • N. Review and Summary

  Overview:
  Regulatory scrutiny of software has become increasingly more sophisticated and in-depth. Devices and manufacturing processes automated with software gain considerable attention during submission reviews and manufacturing inspections. Requests for additional software information and documentation are frequent. In fact, FDA’s Software Guidance documents for Reviewer’s Guidance, Validation, and OTS (Off-the-shelf) Software significantly impact manufacturers! This course will help to understand how to comply to current regulations and how to prepare for future regulatory requirements & guidance. Upcoming new software standards will be of considerable importance to manufacturers. In addition to device software, discussion will include manufacturing process and test related software of any type of medical device, including disposables & pharmaceuticals. This course is important in preparation for FDA & ISO Manufacturing and Design Control inspections; as well as, 510(k), IDE, PMA or CE Mark approvals. Software SOP templates and Checklists for auditing software both in devices and in automated systems will be presented.

  What you will learn:

  Benefits of Attending:

  Abbreviated Outline:

  Speaker: Dennis Rubenacker, Marc Goodman