Good Manufacturing Practice (GMP)

This course is designed for people who are new to a GMP regulated environment or need a refresher in the latest GMP changes. It covers the current PIC/S, FDA and TGA GMP guidelines.

As the FDA states; “Training in current Good Manufacturing Practise shall be conducted by qualified individuals on a continuing basis and with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them.” – 21 CFR 211.24 (a)

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

  • Know the history of cGMPs and the major precursors to current GMPs
  • Understand the basics of the cGMP and basic documentation practice
  • Know how to integrate cGMP requirements into daily work tasks
  • Know how to quickly access further cGMP information
  • Understand the importance of roles to cGMP compliance
  • Understand contamination and microorganisms
  • Know how a clean room works and appropriate behaviours within GMP facilities
  • Understand Quality Management, the relationship between Quality Assurance, Quality Control, the GMP codes and Quality Management Systems
  • Understand GMP documentation error minimisation and the GMP requirements for documentation 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?

  • Quality Assurance personnel
  • Quality Control personnel
  • Operations and Manufacturing personnel
  • People new to the GxP regulated industries
  • Validation personnel