On site GMP Training Course – Introduction
Refresher or Introduction GMP Training Course is designed for people who are new to a cGMP regulated environment or someone just in need of a refresher in the latest GMP changes. It covers the current EU, PIC/S, FDA and TGA GMP guidelines and recent updates.
As the FDA states; “Training in current Good Manufacturing Practice 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)
This is one of PharmOut’s most popular courses when run in our training center and is usually oversubscribed, so book early.
Course Duration & Location
One day, on your site or at an offsite location.
PharmOut’s GMP training courses can be delivered anywhere in the world, we will ask you to cover reasonable travel costs, with this you will save the costs associated with your staff travelling to a external venue to be trained, so it becomes cost effective if you have several people needing training.
Our 2018 pricing is A$350 per person or A$3500 per day plus GST for up to 15 participants. This does not include travel costs.
*Smart device and WiFi is needed for all attendees.
Contact us for a quote if you need more that 10 trainees to be trained.
What you will learn
Upon completion of this GMP training 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
Participants will receive a workbook with will contain 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.
A written assessment is conducted at the end of the course.
The GMP Training 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
If you would like a quote or would need to ask questions, please contact us.
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