Validation of Computer Systems for Quality and Software Embedded Medical Devices 2017

Topics

• A "Working Definition" of VV, Qualification, and related terms
• Verification and Validation, differences and how they work together
• Software Verification Validation requirements of the FDA and ISO
• Recent regulatory expectations
• Device and Manufacturing software requirements for V V
• The latest FDA Software Guidance Regulations, including Part 11 -impact on VV strategies
• How to determine handle software for different Levels of Concern
• How to determine demonstrate an appropriate V V strategy
• Impact of FDA, Mobile APPS, Cyber Security, and software standards such as IEC 62304
• What VV is required for 3rd Party software-custom and Off-the-shelf
• V V documentation and level of detail required for device submissions
• What to look for during software vendor audits
• Key "milestones" and "tasks" in a project as well as discussing audience related projects for discussion points
• How to document a " risk -based" rationale, and use it in a resource-constrained environment
• The key elements of a Product VV protocol and expectations with the Summary Report
• Master and Individual Validation Plans
• Sample sizes and their justification
• Process and/or Production/ Test Equipment VV Files/Protocols
• QMS Electronic Records and Electronic Signatures per 21 CFR 11
• The key elements of Software VV expected by the FDA and how to document appropriately and adequately
• Quality System Regulation vs Pre-Market Submissions
• Regulatory Requirements for Software Validation and Benefits
• Verification and Validation process
• Software requirements in specifications
• Software development as part of system Design
• IQ/OQ/PQ in software VV and next steps for compliance
• Software validation after a change
• Software life cycle verification
• What is Process Validation
• Validation of Off-the-Shelf Software and Automated Equipment
• Process Validation Equipment Qualification
• What are FDA and international requirements for Process Validation
• Where and how does software validation into the Validation Plan
• Examples of successful Process Validation activities
• Seminar attendees are encouraged to bring examples of their work from the functional area on the various topics as applicable for group discussion
• Recent examples of FDA Warning Letter cites and other enforcement actions for non-compliant VV findings...what went wrong
• Guidance for Industry, Trends and FDA Inspection Enforcement Statistics and Trends
• Pain points, challenges and solutions
• Prepare for Regulatory Inspections, including FDA and Operate in a State of Readiness

Who should Attend

• Regulatory Affairs Specialist
• Regulatory Affairs Management
• Compliance
• Auditors
• Engineering/Technical Services
• Quality Assurance Management
• Consultants
• Operations/Manufacturing
• IT/IS
• Quality Assurance or Quality Control Professionals
• Production Management
• R&D
• Process Engineers
• Manufacturing Engineers
• Validation Engineers
• Software Engineers
• Hardware and software vendors, sales and marketing
• Project Managers