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

Due to significant technology innovation*, we are reducing our pricing to A$300 per person or A$3000 per day plus GST from 2017, with discounts available when more than 10 people attend the same course. 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

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 –

Filter Courses:

EventVenueDate
Melbourne Cleaning Validation TrainingPharmOut Training Centre
  • 13 December 2017 9:00 am
Sold Out
Melbourne PIC/S PE009 GMPClarion Hotel - Melbourne
  • 14 December 2017 9:00 am
Sold Out
Melbourne Industry Update DinnerClarion Hotel - Melbourne
  • 14 December 2017 6:00 pm
Sold Out
Melbourne GMP SOP Technical Writing TrainingClarion Hotel - Melbourne
  • 20 December 2017 9:00 am
Sold Out
Hong Kong PIC/S PE009 GMPL’hotel Nina ET Convention Centre
  • 30 January 2018 9:00 am
Register
Melbourne Quality Risk Management Training (ICH Q9)PharmOut Training Centre
  • 02 February 2018 9:00 am
Register
Brisbane Self Inspection (internal audit) TrainingNovotel Brisbane
  • 06 February 2018 9:00 am
Register
Brisbane Process Validation TrainingNovotel Brisbane
  • 06 February 2018 9:00 am
Register
Sydney Process Validation TrainingEden Gardens and Garden Centre - Sydney
  • 07 February 2018 9:00 am
Register
Brisbane CAPA TrainingNovotel Brisbane
  • 07 February 2018 9:00 am
Register
Brisbane Data Integrity TrainingNovotel Brisbane
  • 08 February 2018 9:00 am
Register
Sydney Statistics for Process Validation TrainingEden Gardens and Garden Centre - Sydney
  • 08 February 2018 9:00 am
Register
Melbourne GAMP & Computerised Systems Validation Training CoursePharmOut Training Centre
  • 12 February 2018 9:00 am
Register
Adelaide CAPA TrainingThe Lion Hotel - Adelaide
  • 13 February 2018 9:00 am
Register
Adelaide GAMP & Computerised Systems Validation TrainingThe Lion Hotel - Adelaide
  • 14 February 2018 9:00 am
Register
Melbourne CAPA TrainingPharmOut Training Centre
  • 15 February 2018 9:00 am
Register
Perth GAMP & Computerised Systems Validation TrainingNovotel Langley - Perth
  • 15 February 2018 9:00 am
Register
Melbourne Quality Management Systems - ISO13485 TrainingPharmOut Training Centre
  • 20 February 2018 9:00 am
Register
Brisbane GAMP & Computerised Systems Validation TrainingNovotel Brisbane
  • 20 February 2018 9:00 am
Register
Perth Process Validation TrainingNovotel Langley - Perth
  • 21 February 2018 9:00 am
Register
Perth Industry Update DinnerNovotel Langley - Perth
  • 21 February 2018 6:00 pm
Register
Brisbane Industry Update DinnerNovotel Brisbane
  • 27 February 2018 6:00 pm
Register
Sydney GMP SOP Technical Writing TrainingEden Gardens and Garden Centre - Sydney
  • 06 March 2018 9:00 am
Register
Sydney Cleaning Validation TrainingEden Gardens and Garden Centre - Sydney
  • 07 March 2018 9:00 am
Register
Sydney PIC/S PE009 GMPEden Gardens and Garden Centre - Sydney
  • 07 March 2018 9:00 am
Register
Melbourne ISO 14971 Quality Risk Management Training – DevicesPharmOut Training Centre
  • 09 March 2018 9:00 am
Register
Melbourne Self Inspection (internal audit) TrainingPharmOut Training Centre
  • 13 March 2018 9:00 am
Register
Adelaide Self Inspection (internal audit) TrainingThe Lion Hotel - Adelaide
  • 14 March 2018 9:00 am
Register
Perth Self Inspection (internal audit) TrainingNovotel Langley - Perth
  • 15 March 2018 9:00 am
Register
Auckland PIC/S PE009 GMPNovotel Auckland Airport
  • 20 March 2018 9:00 am
Register
Sydney Design, Commissioning, Qualification and Startup of CleanroomsEden Gardens and Garden Centre - Sydney
  • 21 March 2018 9:00 am
Register
Sydney Sterile/Aseptic Manufacturing TrainingEden Gardens and Garden Centre - Sydney
  • 22 March 2018 9:00 am
Register
Adelaide Data Integrity TrainingThe Lion Hotel - Adelaide
  • 27 March 2018 9:00 am
Register
Sydney Quality Risk Management Training (ICH Q9)Eden Gardens and Garden Centre - Sydney
  • 28 March 2018 9:00 am
Register
Sydney Data Integrity TrainingEden Gardens and Garden Centre - Sydney
  • 29 March 2018 9:00 am
Register