Course Description
Why should you attend:
Understand Verification and Validation, differences and how they work together
Develop a "Working Definition" of V&V, Qualification, and related terms
Discuss recent regulatory expectations
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, Mobile APPS, Cyber Security, 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.
How to document a "risk-based" rationale, and use it in a resource-constrained environment
Determine key "milestones" and "tasks" in a project as well as discussing audience related projects for discussion points
Generate Master and Individual Validation Plans
Learn the key elements of a Product V&V protocol and expectations with the Summary Report
Develop Process and/or Production/Test Equipment V&V Files/Protocols
Sample sizes and their justification
Learn the key elements of Software V&V expected by the FDA and how to document appropriately and adequately
QMS Electronic Records and Electronic Signatures per 21 CFR 11
Regulatory Requirements for Software Validation and Benefits
Quality System Regulation vs Pre-Market Submissions
Software requirements in specifications
Verification and Validation process
IQ/OQ/PQ in software V&V and next steps for compliance
Software development as part of system Design
Software life cycle verification
Software validation after a change
Validation of Off-the-Shelf Software and Automated Equipment
What is Process Validation
What are FDA and international requirements for Process Validation
Process Validation & Equipment Qualification
Examples of successful Process Validation activities
Where and how does software validation integrate into the Validation Plan
Recent examples of FDA Warning Letter cites and other enforcement actions for non-compliant V&V findings...what went wrong
Seminar attendees are encouraged to bring examples of their work from the functional area on the various topics as applicable for group discussion
Review and discuss pain points, challenges and solutions
Guidance for Industry, Trends and FDA Inspection & Enforcement Statistics and Trends
Prepare for Regulatory Inspections, including FDA and Operate in a State of Readiness Agenda
Day 1 Schedule
Introductions and Overview
Device Concepts, Software Requirements
Software Designs and Implementation Activities
Software Testing
Non-Device Validation
Software development life cycle (SDLC), including examples of commonly used SDLCs
Software V&V documentation
Electronic Records and Electronic Signatures (Part 11)
Software Embedded Medical Device Testing and Validation and Regulatory Expectations and Requirements
Software Standard Operating Procedures related to V&V
Software Quality Assurance Planning
Software Test Strategies & Methodologies
Requirements Validation
Verification and validation, including regulatory definitions, regulatory intent, and common tasks
Regulatory framework and the relationship of various sources of regulatory requirements
Key regulations, standards, and guidance documents
Integrating risk management processes
Design control and software validation guidance
Testing-level strategies (unit, integration, system, user)
Methods development and documentation requirements, plus test protocol content
Configuration management, change management, and maintenance strategies
Documentation requirements for premarket submissions
Processes, procedures, and outputs for typical phases (e.g., examples, roles, relationships)
Defects and issues management
Design and quality planning, including traceability and reviews
Lessons learned from case studies and warning letters
Design software validation plans that build confidence in the software and comply with regulatory requirements for device, commercial off-the-shelf, and Quality System software
Use risk management to focus validation activities to minimize risk
Streamline elements of the Quality System for cost-efficient software development and validation
Day 2 Schedule
Recap of Day 1
Regulatory Guidance and Regulations and Additional Resources
Select appropriate lifecycle models and synchronize validation activities for all types of software
Write unambiguous, testable requirements
Integrate best development engineering practices to support validation efforts
Organize test designs, test cases, and test procedures that effectively cover requirements being verified, and that provide opportunities for review and management of the process
Regulatory and Compliance Overview/FDA Snapshot on V&V for Manufacturers/Master Validation Planning
FDA's approach and Risk Management Tools with ISO 14971, ICH and other Guidance/Standards - Product, Process Equipment V&V Product/Device V&V
Software V&V and where and how does software validation integrate into the Validation Plan
Quality Management System/21 CFR Part 11 expectations and requirements
Avoid or Minimize Compliance Concerns and Issues: Q&A/FAQs and review of company documentation
Review of group activity and hands-on examples and activities show real-world implementation of useful governing principles, tools and templates and the most recent enforcement actions for trending, compliance and governance
Debrief/Adjourn
Recap of topics and key discussion points and take away message
FAQs and latest trends with industry and regulators Audience
• Regulatory Affairs Management
• Regulatory Affairs Specialist
• Auditors
• Compliance
• Quality Assurance Management
• Engineering/Technical Services
• Operations/Manufacturing
• Consultants
• Quality Assurance or Quality Control Professionals
• IT/IS
• R&D
• Production Management
• Manufacturing Engineers
• Process Engineers
• Software Engineers
• Validation Engineers
• Project Managers
• Hardware and software vendors, sales and marketing