2017 GMP, Engineering & Validation Forum

The 2017 National Life Science GMP and Validation Forum

A Better Australian Life Science Manufacturing Industry by Design – the National Life Science Forum. 

Beginning in 2011 as the National Validation Forum, PharmOut facilitated innovative thinking and proposed the early adoption of the US FDA Process Validation thinking, this innovative thinking has continued as we have shared ideas and experiences around industry hot topics. This year is no different as we talk about, Industry 4.0, Data Integrity, Quality Metrics, PIC/S Version 14, specifically – Annex 1, Annex 11 and Annex 15 to name a few.

There will be 3 main tracks this year –

1 – Non sterile manufacturing (upcoming PIC/S Version 14)

Following the well supported training on PIC/S version 13, we have honed our points to consider, and now have many practical tips.

2 – Sterile manufacturing and the new Annex 1 (due end June) and Annex 15

As we did last year ,we focused on Sterile Manufacturing and Points to consider, emerging RM methods and the Annex 15, qualification and validation update which is about to “hit” Australia, why not join us in the leading discussion in Australia.

3 – Engineering and Architecture

This will be the 3rd year PharmOut will have a dedicated track for Engineers by Engineers, well and a few Architects too. We will talking about designing and building tablet plants, sterile manufacturing plants and a special session on Complementary Medicines manufacturing plants.

In 2017, we with the kind help from the sponsors are facilitating the 7th GMP & Validation Forum on Monday and Tuesday the 24th and 25th July 2017, followed by Master Classes

To make the most of your trip Melbourne, we will be running Master Classes on the 26 / 27 July.

  1. Sterile / Aseptic Manufacturing (the new Annex 1),
  2. Process Validation & Statistical
  3. PIC/S Version 13 (and 14 is released) and the new Annex 11, Data Integrity

Event Details

Date: 24-25 July 2017
Start time: 8:30AM for 9:00AM start
Venue: Novotel on Collins, 270 Collins Street, Melbourne

Paperless

As part of our paperless drive we will be using Glisser as our presentation tool of choice. This will enable you to follow the presentations on a smart device and download the PDF once complete. More details will be provided on the day, and ample spots for charging will be available. Glisser can easily be run on your 3G/4G data connection, or accessed using the in house Wi-Fi

Dress Code

Business Casual

Food & Drink

On Arrival: Coffee/tea and a selection of sweet and savoury muffins
Morning Tea: Pastries and fruit platter
Lunch: Hot meal, salad, fresh fruit, soft drink, coffee/tea
Afternoon Tea: Coffee/tea, selection of fresh fruit

Any Questions?
Email: [email protected]
Phone: +61 3 9887 6412 or Toll Free 1800PHARMOUT

Speakers

We have six international speakers focusing on a broad range of subjects and a raft of innovative technologies on show, but it’s the hot topics and case studies as nominated by industry, that have caught my eye, we have –

  • Trevor Schoerie, Managing Director, PharmOut – PIC/S Version 13
  • Ed Jones, Senior Director Global Quality Systems at CSL – Quality Culture 
  • Bryan Wright, ex MHRA, Executive Consultant, PharmOut UK – Minding the gap
  • Gordon Farquharson, ISO 14664 chair, Executive Consultant, PharmOut UK – Annex 1 
  • Barry Hendy, ADDE – Robotics 
  • John Montalto, Director, Quality Assurance Systems at CSL Behring – Quality Metricz
  • Marco Preus, IMA – Equipment selection 

Things to do in Melbourne

To find out more about Melbourne watch the video below. To book travel and accommodation visit Expedia.