Risk-Based Verification and Validation Planning to Meet US FDA and ISO 13485 Requirements

Risk-Based Verification and Validation Planning to Meet US FDA and ISO 13485 Requirements is a webinar that covers topics such as:

  • The Master Validation Plan and the Individual V&V Plan
  • Verification or Validation -- Current regulatory expectations
  • Product V&V versus Process / Equipment V&V versus QMS V&V
  • What is "risk-based"?
  • Using the Risk Management tools of ISO 14971 and ICH Q9
  • When / How to Use DQ, IQ, OQ, PQ, ASTM E2500 Equivalents
  • Key recent compliance problems
  • The 11 Elements of the Software VT&V "Model"

Risk-Based Verification and Validation Planning to Meet US FDA and ISO 13485 Requirements is intended for:

  • Regulatory Affairs
  • Senior management
  • Production
  • Quality Assurance
  • All personnel involved in verification and/or validation planning, execution and documentation
  • Engineering, indluding Software

Future Events

Risk-Based Verification and Validation Planning to Meet US FDA and ISO 13485 Requirements 2020

Important

Please, check the official conference website for possible changes, before you make any traveling arrangements

Prices are for evaluation only.

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