Good Documentation Practice (GDP)

This Good Documentation Practice (GDP) course provides participants with the skills to write clear, concise procedures and validation protocols. You’ll learn practical tips on how to structure the documents within a Quality Management System e.g. when to use a Policy vs when to use an SOP.

This course is ideal for all people who work in the Life Sciences industries who are required to create, complete and/or review documents or Technical Writers who want to move into GMP regulated industries.

The Code of Good Manufacturing Practice for Medicinal Products states;

“Good documentation constitutes an essential part of the quality assurance system. Clearly written documentation prevents errors from spoken communication and permits tracing of batch history. Specifications, Manufacturing Formulae and instructions, procedures, and records must be free from errors and available in writing. The legibility of documents is of paramount importance.”

Course Duration & Location

3-5 days, on your site or at one of our training centers.

CiPharma’s training courses can be delivered anywhere in the world. If your site is not in a city we have an office in then we ask you to cover the travel costs from our nearest office. You’ll save the costs associated with your staff travelling to be trained, so it becomes cost effective if you have several people needing training.

What you will learn

  • Understand the importance of good documentation practices
  • Know how to construct and author effective, GMP-compliant documents
  • Know how to incorporate modern learning techniques into documents and reduce the documentation errors caused by ill designed documents
  • Achieve successful regulatory audits
  • Understand the importance of good documentation practices
  • Know how GDP can save your business unit time and money
  • Understand the GMP requirements for documentation formats, templates and documentation systems
  • Know how to structure documentation hierarchy systems

  • Course materials

    Participants will receive a copy of the presentation(s), relevant notes and workshop materials.
    A certificate of completion will be issued to participants who successfully complete the assessment.

    Assessment

    A written assessment is conducted at the end of the course.

    Course Format

    The course is a combination of lecture-style learning and active workshops with participants working in small groups on assigned tasks.

    Who should attend?

  • All Quality Assurance personnel
  • All Quality Control personnel
  • All Operational and Manufacturing personnel
  • Technical Specialists new to the GxP regulated industries
  • Validation personnel
  • Technical Document Writers