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Good Documentation Practices

Implementing efficient practices that meet full GLP/GMP/ISO and FDA requirements

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Benefits of attending for you and your company

At the end of the course you will...

know what the GMP regulations and ISO guidelines require of the documentation function

understand how the policies and culture of your company impact the documentation function, and how to strategize to implement a successful documentation function

recognize what is required to establish a sound documentation function within your company or within your department

know where the corporate and cultural “road blocks” are, and either how to avoid them, or how to best steer around them

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Who Should Attend

Personnel involved with managing the documentation function at a corporate, division or departmental level.

The course will also be of extreme interest to quality assurance personnel, particularly quality assurance auditors, seeking to know what makes for a sound documentation function.

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Course Language

The course is presented in English

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Course Overview

Documentation of production and analytical methods (standard operating procedures), product specifications, facility and parts drawings, technology transfer documents, validation protocols and batch record documentation are the most vital tools available for assuring product quality, integrity and consistency.

Establishing and managing an efficient and effective, non-bureaucratic documentation system that meets operational and regulatory needs is a major challenge. Doing so without becoming a systems bottleneck is a formidable task, especially when the needed staff are "never available"! The course is designed to review the complete documentation function and provide insight into the right and wrong ways of establishing and managing this essential function.

Some company’s documentation systems are, by their very design, doomed to provide inferior and inefficient service to meet user and regulatory needs. The course provides examples of both effective and regulatory needs. Current paper systems and newly developed electronic systems are presented and discussed.

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Course Outline

  • Documentation fundamentals
  • The purpose of documentation
  • Regulatory GLP and GMP issues
  • FDA requirements for electronic signatures and records (21CFR11)
  • Business considerations
  • User expectations
  • System requirements
  • Establishing the documentation function
  • Activities related to document production
  • Convert your paper SOP system to an electronic system TOMORROW !
  • Document types (similarities and differences)
  • Creating documents that help users work right
  • ISO 9000 and documentation
  • Signatures and initials: what they mean
  • Records and reports:
    - Logs, Deviation Reports
    - Batch Production  and Packaging Records
    - Laboratory Records
    - Calibration and  Maintenance Records

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