Verification vs. Validation - Product Process Software and QMS 2016

Key Topics

• Recent regulatory expectations
• Verification and Validation, differences and how they work together
• Key "milestones" and "tasks" in a project
• How to document a " risk -based" rationale, and use it in a resource-constrained environment
• Compile "generic" and Individual Validation Plans
• And document key subject "inputs"
• How to develop Process and/or Production/ Test Equipment VV Files/Protocols
• The key element of a Product VV File /Protocol
• Sample sizes and their justification
• A grasp of basic Test Case construction
• Hardware and software vendors, sales and marketing
• The key elements of Software VV expected by the FDA and how to document
• How to compile QMS Electronic Records and Electronic Signatures VVs to satisfy 21 CFR Part 11
• A field-tested software VV documentation "model"

Who should Attend

Attendees from medical devices, pharmaceutical, diagnostic, and biologics companies involved in:

• Regulatory Affairs
• Senior and middle management and staff
• QA/QC
• Quality Assurance or Quality Control Professionals
• R&D
• IT/IS
• Manufacturing Engineers
• Production Management
• Software Engineers
• Process Engineers
• Hardware and software vendors, sales and marketing
• Project Managers