New PIC/S GMP Training Course PE 009-13

New PIC/S GMP Training Course PE 009-13

Overview

PIC/S GMP Training

PIC/S PE 009-13 for the manufacture of medicinal products was issued on the 1st January 2017.  The TGA adopted this version on 1st January 2018 with full implementation due on the 1st January 2019. To help you prepare for the change by the TGA, PharmOut have developed a PIC/S training course specifically to help you close the gap between PIC/S GMP version 8 and 13, evaluate how your transition period is going and help you see the path forward by including the recent PIC/S version 14 updates. The course also covers the “hot topics” and recent inspection deficiencies so you can avoid the same non-conformances.

In addition to the course materials, attendees will get a “Close the gap” tracking spreadsheet to make sure that you are ready for full implementation.

 

We regularly offer PIC/S GMP training courses and events in Adelaide, Auckland, Brisbane, Hong Kong, Melbourne, Perth, and Sydney, or in other countries, on an as-needed basis.

What you will learn

The course will provide participants with an understanding of:

  • Changes between the codes and a “checklist of changes”
  • How companies apply the new changes in PIC/S PE 009-13 to internal policies and procedures (and how they relate to previous requirements i.e. PIC/S PE 009-8)
  • The requirements of version 13 and insight into the recent version 14 updates and their application in the pharmaceutical workplace
  • Common inspection deficiencies and how to avoid them
  • Practical application of the changes through activities.

 

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 new PIC/S PE 009-13 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
  • Qualification/Validation personnel
  • Engineering & Automation personnel
  • Regulatory Affairs personnel
  • Anyone within the GMP industry interested in learning about or improving their knowledge of current PIC/S GMPs.

 

AUD$400.00 + 10% GST

Bring Your Own Device (BYOD)

To offer you this unique, cost-effective training, we have combined two of our aspirational organisational goals, Paperless and Innovation, for you to attend you must bring your own device and we will supply an internet connection, WiFi will be provided free of charge in all venues.

Prices are per person and include morning tea, lunch and afternoon tea

Register for the new PIC/S PE 009-13 GMP Training Course below:

If you need any assistance, would like a quote for personalised group training, or just have a general training question don’t hesitate to contact us.

EventVenueDate
Brisbane PIC/S PE009 GMPNovotel Brisbane
  • 02/04/2019 9:00 am
Register
Sydney PIC/S PE009 GMPEden Gardens and Garden Centre - Sydney
  • 03/04/2019 9:00 am
Register
Melbourne PIC/S PE009 GMPPharmOut Training Centre
  • 16/04/2019 9:00 am
Register
Auckland PIC/S PE009 GMPNovotel Auckland Airport
  • 13/06/2019 9:00 am
Register
Adelaide PIC/S PE009 GMPThe Lion Hotel - Adelaide
  • 11/09/2019 9:00 am
Register
Perth PIC/S PE009 GMPNovotel Langley - Perth
  • 12/09/2019 9:00 am
Register
Brisbane PIC/S PE009 GMPNovotel Brisbane
  • 18/09/2019 9:00 am
Register
Sydney PIC/S PE009 GMPEden Gardens and Garden Centre - Sydney
  • 19/09/2019 9:00 am
Register
Melbourne PIC/S PE009 GMPPharmOut Training Centre
  • 24/09/2019 9:00 am
Register

Course Code: PO1800