21 CFR Part 11 and Risk Assessment


21 CFR Part 11 and Risk Assessment is a workshop that covers topics such as:

  • Key Requirements of Part 11
  • 21 CFR Part 11 Compliance
  • Learning from Recent Warning Letters
  • Annex 11
  • Achieving Data Integrity
  • Computer System Validation
  • VMP & Design Specifications
  • Meeting Data Integrity Regulations
  • Risk Based Validation
  • Risk Assessment
  • CASE STUDIES ….and More
  • SOPs and Best Practices

21 CFR Part 11 and Risk Assessment brings together:

  • Regulatory Affairs Management and Personnel
  • Quality Assurance Management and Personnel
  • Operations Management and Personnel
  • Research & Development Management and Personnel
  • Manufacturing Management and Personnel
  • Production Management and Personnel
  • Facility and Maintenance Management and Personnel
  • Engineering Management and Personnel
  • Everyone involved in Product, Process, CAPA Resolution, Failure Investigation Responsibilities

Future Events

21 CFR Part 11 and Risk Assessment 2020


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

Prices are for evaluation only.

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