GMP Documentation Training

Course code: GDP02

Overview

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.

As the Australian 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

One day, on your site or at an offsite location.

PharmOut'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.

Pricing

Indicative pricing is A$650 per person or A$6000 per day, with discounts available when more than 10 people attend the same course.

What you will learn

Upon completion of this course participants will:

• 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.

 

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

More information

If you would like a quote or would need to ask questions, please contact us.