PIC/S GMP Training Course PE 009-14

PIC/S GMP Training Course PE 009-14

Overview

PIC/S PE 009-14 for the manufacture of medicinal products was issued on the 1^st July 2018.  This GMP training course covers all you need to know about PIC/S Part 1 – Manufacture of Medicinal Products.  The TGA  have announced that version 14 will be adopted as of July 2021.  We cover all of the 9 Chapters and focus on the “hot topics” and recent inspection deficiencies so you can avoid the same non-conformance’s.

This PICS GMP training course is designed as a practical workshop with lots of discussions and activities and will leave you with an action list to take back to your organisation and implement some Continuous Improvement initiatives.

We regularly offer PIC/S GMP training courses and events in Adelaide, Auckland, Brisbane, Melbourne, Perth, and Sydney, or in other countries, on an as-needed basis. We also offer all our courses as virtual live workshops.

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 009-14 to internal policies and procedures
• Common inspection deficiencies and how to avoid them
• Practical application of the key requirements 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.

PICS Training Course format

The new PIC/S PE 009-14 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$450.00 + 10% GST Full Day Training

AUD$250.00 + 10% GST GMP Refresher Half Day Training

Prices are per person and include morning tea, lunch and afternoon tea (not included for virtual sessions)

Register for the new PIC/S PE 009-14 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
GMP Refresher / v14 Transition- Virtual	Virtual Training	11/05/2021 11:00 am	Register
PIC/S PE009 GMP - Virtual	Virtual Training	02/06/2021 9:00 am	Register