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Good Documentation Practices Training

Overview

This course provides helpful information by presenting topics associated with the writing, formatting, execution and management of SOPs & MBRs that contribute to consistent and efficient operations. It also discusses good documentation practices required by companies to ensure GMP compliance and relates the role which SOPs & MBRs play in achieving the required level of compliance and quality.

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Outlines

  • Good Documentation Practices
  • Regulatory inspectors expectations for SOPs & MBRs
  • The role of SOPs & MBRs with respect to manufacturing and GMP operations, global harmonization, documentation and document control
  • Reviewing current SOPs & MBRs to determine gaps and overlaps to strengthen the existing documentation system
  • Maintenance of SOPs & MBRs
  • Designing SOP & MBR templates to optimize efficiency of organization
  • The team approach to SOP & MBR writing, defining responsibilities and knowing the audience
  • The importance of capturing the actual flow of an operation within the document
  • Writing tips on how to keep the document concise, unambiguous and accurate
  • Training of SOP & MBR documents
  • Managing revisions and deviations through a document Change Control System

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