cGMP Compliance Series: Record Keeping, Document Control & How to Write SOPs

Learn how to create, manage and control documents for good GMP practices, inspectors, auditors and safety.

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cGMP Compliance Series: Record Keeping, Document Control & How to Write SOPs
Webinar Recording: Record Keeping, Document Control & How to Write SOPs Audio
cGMP Compliance Series: Record Keeping, Document Control & How to Write SOPs Transcript
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Presented: May 28, 2009

Documents tell the true story of compliance. Without good documents and document control all of your GMP efforts may count for nothing. Learn how to create, manage and control documents for good GMP practices, inspectors, auditors and safety.

  • What is good documentation and good document control?
  • What does it look like and how is it useful?
  • How does proper documentation save your company money?

Topics covered include: The role of the documentation manager/document control manager; general documentation practices; Writing documents & SOPs - details on components and how to; Recordkeeping strategies; Worksheets vs. Logbooks; Document change control; Training records; Record retention, purging & destruction; FDA Inspections

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