Course Description

Good documentation is vital for doing business in the regulated world from discovery through marketplace. It is also important for due diligence and regulatory inspections, and is necessary for the success of your products and services. While the regulations tell you what you must do, they don't tell you how. Based on industry best practices, this pharmaceutical document management course clarifies how to refine your existing system, create a new one, or prepare to transition from a manual system to electronic controls.

This pharmaceutical document management course addresses what documents you need to control, what documentation you need to support your actual system and how to keep your documents current and compliant.


  • Review regulatory requirements for documentation.
  • Review Industry standards
  • The documents you need to control, from source data to dossiers
  • Components of document systems
  • System administration
  • Document review, approval, and revision
  • Document distribution, retrieval, and archiving
  • Going electronic from a manual system
  • Features of electronic record keeping
  • Understanding e-system requirements: validation, security, accountability, and audit trails
  • Standard Operating Procedures and other documents to support the system
  • Consistency in format and terminology
  • Training requirements and training documentation
  • Remaining "inspection ready"
  • Auditing the system

Who Will Benefit

Pharma, medical device, and biotech professionals who manage documents for all therapeutic product development and marketing activities (including pre-clinical, clinical, QA, and regulatory functions) should attend. This effective document management course is also valuable for QA auditors who need to understand what constitutes sound documentation and documentation management.

Faculty Kelly Thomas

Kelly Thomas, Vice President at America’s Quality Operations, has 20 years of hands-on experience in the industry. She has worked with reputed facilities like FDA, EMEA, IMB, JP, and Health Canada. Her core expertise includes computer system validation, equipment process validation, and facilities validation. In addition, she will guide you on implementing a robust quality system, evaluating the KPIs of the facility, and executing high-quality management.


RAPS - This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

World Compliance Seminars (WCS) is a Regulatory Affairs Professional Society (RAPS) RA Professional Development Portal provider. World Compliance Seminars is committed to enhancing the ongoing professional development of regulatory affairs professionals and other stakeholders through appropriate regulatory affairs learning activities and programs. World Compliance Seminars has agreed to follow RAPS-established operational and educational criteria

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