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:
- 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.
Benefits of Attending:
- 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.
Abbreviated Outline:
- 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
Speaker: Dennis
Rubenacker, Marc Goodman
