Breaking news – Visual Inspection Training Course Added
The National GMP & Validation Forum is quickly becoming the most supported conference to exchange ideas, thoughts and catch up with the developments in the EU and USA and how they apply these in an Australian context. The event started in 2012 with PharmOut hosting and at times leading the discussion on how to do make validation a value adding business activity. This first conference leveraged off the ICH guidelines, after many of our team attended international conferences, training courses and practical, hands on in-the-trenches consulting work they did in the EU and USA.
At the same time, the FDA published its revised process validation guidance which was used to streamline the Australian validation approach. Reflecting on this, 5 years after the first Forum, whilst many TGA GMP inspectors enthusiastically and proactively joined the forum, the approach described in the FDA guidance and in the recently revised Annex 15 are is still not mandatory in Australia.
The forum has grown in reach and content every year, and we believe that the 2016 Forum promises to be the best yet. For the 2016 forum we have actively engaged with suppliers and industry to join us and share their experiences, latest innovations and international best practice.
As we get closer to finalising the program, we can share some of the highlights that have been confirmed:
The forum will include over 40 speakers from more than 25 different organisations, including sterile, non-sterile and API manufacturers, notable industry suppliers and international experts including:
- Roy Cherris (internationally renowned expert in visual inspection and particulates) is booked to come!! To quote a recent email from an Australian industry leader– “Roy Cherris is very impressive. His company and the McCrone Research Institute is famous for their forensic analysis of particulate matter and promoting appropriate reference libraries for particulate matter sources in the manufacturing process and have helped out some major Pharma’s in US dealing with warning letters and consent decree. I have seen some of his work in USA inspections I performed.”
- Roy will be running a 1 day visual inspection master class in Melbourne on the Wednesday the 13th July 2016 at the Glen Waverley Novotel (bookings will open soon)
- Gordon Farquharson will return with the latest on ISO 14644 updates from late last year and EU WFI changes, as well as engaging sessions on containment and biocontamination.
- Bryan Wright (ex-MHRA GMP Head) will inform us on the latest from the EU regulations, including revisions to Annex 1
- Major international and local vendors, including Rommelag, IMA, Wayahead Systems, Sartorius Stedim, Laftech, Biosafety, Mettler Toledo. Getinge, Kingspan and QikSolve will be presenting their latest technologies and providing expert advice in their relevant areas
- Many manufacturing industry leaders are lined up to present from various local manufacturers, and of course as usual PharmOut consultants will share their thoughts on leading industry practices and presentations on the latest international developments.
The follow on hot topics from the 2015 Forum will continue this year and be expanded to include the new PIC/S code (we think PE009-13 will be released by then), Data Integrity, Cross Contamination, Annex 1, RABS, EU WFI, Rapid Micro Methods, SharePoint as eQMS and of course, validation.
The many sponsors this year have allowed us to fly in 3 international experts and still maintain a sensible price, there is a significant jump in pricing after the 31st May, please book early!
Early bird pricing for the conference ends on May 31.
To book your place visit : National GMP and Validation Forum
Huge “thank you” to the forum sponsor – Sartorius Stedim Biotech
Sartorius Stedim Biotech is a leading international provider of integrated solutions for the biopharmaceutical industry. With our extensive portfolio of products, technologies and services, we cover wide areas of the biopharmaceutical process chain, ranging from fermentation, cell cultivation, filtration and purification to media storage and transportation. In process filtration, fermentation and fluid management, our company holds leading positions in the markets it serves across the globe. Our single-use products have become established in nearly all process steps and are playing an increasingly important role in the manufacture of biopharmaceuticals. As a result, we help our customers produce biological medications and vaccines safely and efficiently.