Data Integrity, Good Documentation Practices and Electronic Data Governance

Data Integrity, Good Documentation Practices and Electronic Data Governance is a conference dedicated to the discipline needed to consistently manually document and electronically record the manufacturing & testing of APIs.

Data Integrity, Good Documentation Practices and Electronic Data Governance covers topics such as:

  • How to handle Data Integrity challenges of detection, investigation, regulatory response and CAPA
  • Regulatory Expectations and Laws regarding Data Integrity and Electronic Data Governance
  • Best Practices for creating GMP appropriate Documentation
  • Case Studies that describe real life examples of how companies have handled Data Integrity Issues and how the regulators reacted
  • How the interactive role of the quality systems and plant management can bring about a culture of good GMP documentation
  • How to encourage GMP Documentation discipline on the shop floor, warehouse and labs
  • Electronic Data Governance: Regulatory expectations; what documents / policies / procedures should be in place; how to define the GMP boundaries around automated systems; role of Quality Assurance with automated systems; what to do and how to investigate if there are electronic data integrity problems.

Data Integrity, Good Documentation Practices and Electronic Data Governance brings together:

  • QA-IT Personnel
  • QA Personnel
  • QC Personnel
  • IPQA Personnel
  • Engineering Personnel
  • Manufacturing Personnel
  • GMP Management Personnel
  • Warehouse / Material Management Personnel
  • GMP API Personnel
  • R&D Personnel involved with Tech Transfer
  • CRO / CRAMS Personnel
  • Non-GMP Intermediates Personnel
  • HR Personnel

Past Events

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