Software Verification & Validation Compliance Strategies
Software Verification & Validation Compliance Strategies
(On-site or Virtual Private Group/Company Training)
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Location: On-site or Virtual
Who: Your entire company, department, project team, you select
- Software Verification & Validation requirements of the FDA and ISO.
- The latest FDA Software Guidance & Regulations, including Part 11 -impact on V&V strategies.
- Device and Manufacturing software requirements for V & V.
- How to determine & demonstrate an appropriate V & V strategy.
- How to determine & handle software for different Levels of Concern.
- What V&V is required for 3rd Party software-custom and Off-the-shelf.
- Impact of FDA, 21st Century Cures Act, Mobile APPS, Cybersecurity, AGILE, and software standards such as IEC 62304
- 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
- B. FDA Recognized Consensus Standards including IEC 62304, AAMI TIR45, IEC /TR80002-1, AAMI TIR 36
- C. Software V & V requirements of the latest International Standards (including IEC 62304) & FDA Guidance Documents
- D. 21 CFR Part 11 Update, Electronic Recordkeeping & Signatures V&V Strategy
- E. Verification and Validation Definitions
- F. Verification & Validation Examples
- G. Software Hazard Analysis
- H. Levels of Concern and how to determine
- I. V & V for Minor, Moderate, and Major Concern Devices or Processes
- J. Verification and Validation Plan- SVVP Template & Specifics
- K. Software Standard Operating Procedures related to V&V
- L. Software Quality Assurance Planning -SQAP Template & Specifics
- M. Software Test Strategies & Methodologies
- N. Requirements Validation
- O. Retrospective V & V for Previously Released Software
- P. Case Studies & Workshop
- Q. 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 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.
The Software V&V Strategies seminar will address FDA Recognized Consensus standards regarding software including IEC 62304, Medical device software - Software life cycle processes, AAMI TIR45, Guidance on the use of AGILE practices in the development of medical device software, Application of quality management system concepts, medical device data systems, Moblile APPs, IEC /TR80002-1, Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software & AAMI TIR 36, Validation of software for regulated processes, 21st Century Cures Act, software as a medical device (SaMD), and Cybersecurity.
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 Device Software & Submissions, Manufacturing Software, 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:
Instructor(s): To be determined based on schedule and your specific needs. All instructors are very experienced and experts in the field being taught. Biographies will be provided and a discussion with the instructor(s) will be arranged so that a proposal can be provided for training that meets your needs.
Duration: Standard course is approximately 8 hours. Customized courses can vary. On-site courses are typically taught in 1 day. Virtual courses can be taught over multiple days, e.g. 2 days for 4 hours/day, etc.
Request a training proposal for your company.