Draft Annex 1 Sterile Training Course – Medicinal Manufacturing

New EU – PIC/S GMP Draft Annex 1 Training Course

Overview

This course has been fascinating to develop and develop and compliments numerous blogs written around this Annex.Annex 1

In this New PIC/S GMP draft Annex 1 training course, we will be covering the most significant changes between the current version PE 009-13, and what will arguably become PE 009-14.

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:

  • Proposed changes between the new and old
  • a “checklist of changes”
  • The requirements of new draft, and its application in the sterile or aseptic clean rooms.
  • Practical application of the changes through activities.

 

Course materials

Participants will receive a soft 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 draft Annex 1 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 includes morning tea, lunch and afternoon tea

Register for the new Draft Annex 1 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.

Course Code: PO1819