New PIC/S GMP Training Course PE 009-13

New PIC/S GMP Training Course PE 009-13

Overview

The New PIC/S GMP Training Course PE 009-13 for the manufacture of medicinal products was issued on the 1st January 2017, the TGA and MedSafe have indicated that they will now adopt this version in 2017. 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, in addition attendees will get white papers, audit checklist and a “Close the gap” tracking spreadsheet to make sure that you are ready.

In this New PIC/S GMP training course, we will be covering the most significant changes since the publication of PE 009-13, and will compare them to both PE 009-12 and PE 009-8, the current version in Australia and New Zealand.

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 a 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 existing (or old!) requirements i.e. PIC/S PE 009-8
  • The requirements of PE 009-13, and its application in the pharmaceutical workplace.
  • 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$300.00 + 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 have your own device and a internet connection, WiFi will be provided free of charge in all venues. Learn more click here.

Prices are per person and includes 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.

Event Venue Date
PIC/S PE 009-13 GMP & Annex 11 - Masterclass Novotel Melbourne on Collins
  • July 26, 2017 9:00 am
Register

Course Code: PO1700