On site GMP Training Course – Introduction

On site GMP Training Course – Introduction

Overview

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.

Pricing

Pricing per course is A$400 per person or A$4,000 per day plus GST for up to 15 participants.

This does not include travel costs.

*Smart device and WiFi may be needed for attendees for certain courses.  If so, this will be designated in your registration confirmation materials.

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

Course materials

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.

Assessment

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

Course Format

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

More information

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

Public Courses and Events

Find a public course or event in a city near you –

Search:

Event Venue Date
GMP & Engineering Forum 2019 - Attendees Pullman Melbourne On The Park
  • 22/07/2019 8:30 am
Register
GMP & Engineering Forum 2019 - Sponsors Pullman Melbourne On The Park
  • 22/07/2019 8:30 am
Register
Mindset 4.0 Masterclass Canterbury International Hotel
  • 24/07/2019 9:00 am
Register
Auditing Engineering Systems and Critical Utilities Masterclass Canterbury International Hotel
  • 24/07/2019 9:00 am
Register
Melbourne Good Distribution Practice Canterbury International Hotel
  • 30/07/2019 9:00 am
Register
Melbourne GAMP & Computerised Systems Validation Training Course Canterbury International Hotel
  • 31/07/2019 9:00 am
Register
Adelaide GMP SOP Technical Writing Training The Lion Hotel - Adelaide
  • 01/08/2019 9:00 am
Register
Adelaide CAPA Training The Lion Hotel - Adelaide
  • 02/08/2019 9:00 am
Sold Out
Sydney Self Inspection (internal audit) Training Eden Gardens and Garden Centre - Sydney
  • 07/08/2019 9:00 am
Register
Sydney CAPA Training Eden Gardens and Garden Centre - Sydney
  • 08/08/2019 9:00 am
Register
Sydney GMP SOP Technical Writing Training Eden Gardens and Garden Centre - Sydney
  • 23/08/2019 9:00 am
Register
Sydney PIC/S PE009 GMP Eden Gardens and Garden Centre - Sydney
  • 26/09/2019 9:00 am
Register
Melbourne PIC/S PE009 GMP Canterbury International Hotel
  • 01/10/2019 9:00 am
Register
Melbourne Self Inspection (internal audit) Training Canterbury International Hotel
  • 02/10/2019 9:00 am
Register
Melbourne GMP SOP Technical Writing Training Canterbury International Hotel
  • 03/10/2019 9:00 am
Register
Auckland CAPA Training Novotel Auckland Airport
  • 10/10/2019 9:00 am
Register
Melbourne Data Integrity Training Canterbury International Hotel
  • 29/10/2019 9:00 am
Register
Sydney Data Integrity Training Course Eden Gardens and Garden Centre - Sydney
  • 31/10/2019 9:00 am
Register
Melbourne CAPA Training Canterbury International Hotel
  • 12/11/2019 9:00 am
Register
Melbourne GMP Facility Design Canterbury International Hotel
  • 15/11/2019 9:00 am
Register
Perth CAPA Training Novotel Langley - Perth
  • 28/11/2019 9:00 am
Register
Australian Medicinal Cannabis Conference 2020 Sofitel Melbourne on Collins
  • 23/03/2020 8:30 am
Register