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The most vital tool available for assuring product quality, integrity, and consistency is good documentation practices. This highly interactive course covers fundamental principles and techniques required to write cGMP procedures. Students can bring samples of their own documentation to be audited during the course. Students will learn techniques to write and improve cGMP documentation to ensure compliance with regulatory documentation.
Topics Include:

  • Document Hierarchy, Document Pyramid
  • SOPs
  • Document Control
  • Laboratory notebook Con
  • Data Integrity and GXP Compliance
  • Auditing
Practical Skills:
  • Understand the fundamental laws and regulations applied to various stages of product development
  • Authoring documents fundamental to GXP compliance, such as SOPs, Work Instructions, Data Collection Forms and Document Templates.
  • Maintaining Laboratory Notebooks for R&D work and assessment of the same
  • Auditing documents to ensure data integrity that is critical to an effective Quality System, including the importance of having supportive documents, such as raw data and Training Records
  • Applying Technical Writing techniques important to scientific documents and understanding the difference between poorly documents and the consequences of the latter
  • Understanding fundamentals of Change Control and Documentation Management.
  • When to communicate electronically and when this might not be the best venue for communication

Course Number: BIOL-40201
Credit: 3.00 unit(s)
Related Certificate Programs: Regulatory Affairs Essentials

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