GMP Basics Training

Course code: GMP01

Overview

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

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 $6,000 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;

• 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

More information

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