Validation Process Course IQ, OQ, PQ, PPQ2020-08-12T11:38:53+00:00

Validation Process Course IQ, OQ, PQ, PPQ

General Information:

Course scope: 18 hours (9:00-17:00)
Course type: Frontal + remote
Location: Science park, Rehovot
Lecturer name: Eran Yona

Course Content:

  • Validation terms & definitions
  • Validation regulatory guidelines
  • The validation V-Model
  • Validation process flow flow
  • VMP
  • URS
  • BOD
  • FAT
  • SAT
  • DR
  • DQ
  • Commissioning
  • Impact & Criticality assessments
  • IQ
  • OQ
  • PQ
  • PPQ
  • Analytical methods validation principles
  • Software validation principles
  • Validation deviations investigations and root cause
  • Re-Validation
  • GMP & validation
  • Risk Assessments for validation
  • Impact & Criticality assessment
  • Good Documentation Practices
    • Common validation observation in external audits
    • Validation protocols content

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