Verification vs. Validation - Product Process Software and QMS 2018

  • 22-23 Jan 2018
  • Hilton Garden Inn St. George, Saint George, UT, United States

Description

Verification vs. Validation - Product Process Software and QMS 2018 is a Workshop that covers topics such as:

  • 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
  • "generic" Master and Individual Validation Plans
  • Key subject "inputs"
  • How to develop Process and/or Production/Test Equipment V&V Files/Protocols
  • Key element of a Product V&V File/Protocol
  • Sample sizes and their justification
  • Get a grasp of basic Test Case construction
  • Hardware and software vendors, sales and marketing field-tested software V&V documentation "model"
  • Key elements of Software V&V expected by the FDA and how to document
  • How to compile QMS Electronic Records and Electronic Signatures V&Vs to satisfy 21 CFR Part 11

Verification vs. Validation - Product Process Software and QMS 2018 brings together 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 and any professional tasked with V&V responsibilities from Pharmaceutical, Medical Devices, Biologics and Diagnostic companies.

Past Events

Important

Please, check "Verification vs. Validation - Product Process Software and QMS" official website for possible changes, before making any traveling arrangements

Event Categories

Health & Medicine: Medical device, Medical laboratories, Pharma
Science: Life Sciences & Biology
Technology: Biotechnology

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