Digital Innovation Conference, Sydney 24-25 Sep 2024
It’s all about digital these days – digitisation, digitalisation, digital transformation, generative and innovative solutions. Australia has a strong reputation for breakthroughs and transformations in medical science and research, but there have been limited offerings locally on computerised systems and technologies. Until now.
In September, ISPE Australasia hosted its 2-day Digital Innovation Conference in Sydney; a splendid synergy of knowledge-sharing resource and networking in the heart of this spectacular city.
As the current Chair of the ISPE GAMP® Community of Practice, and a 10-year resident in Australia, it was a pleasure to be invited onto the conference committee by the ISPE Australasia Affiliate Board and a great opportunity to get to know my local peers.
Conference Summary
Over 60 industry professionals gathered at the conference, warmly welcomed by ISPE Australasia President Kerry Dranganoudis, and with the opening presentation exploring how GAMP enables innovation and improved patient outcomes through its evolving computerised systems management approaches. This was followed by a healthy dose of the real world from Gerry McKiernan (Increment 4) discussing both failed and successful digital deployments and what contributed to each. Tim Boyle, the CEO of ARCS, gave an inspirational talk on the impact of AI within Life Sciences and Louise McGrath (AI Group) demonstrated that alliteration contributes to a good presentation in her talk on Digitalisation, Decarbonisation and Diversification.
The first day continued with a call to strengthen sovereign capability within Australia from Andrew Kiloni (ICN), and with Samuel Jesuadian (ARM Hub) presenting on Robotics and AI adoption. The audience was strongly appreciative of Jennie Burton (AZ) sharing the digital journey that AstraZeneca is taking, offering insights and examples that we could all relate to. Deepa Thakkur (Clayton Utz) followed up with her presentation proving that Data Governance is more than just a GxP requirement, bringing her viewpoint as a lawyer and using a brilliant food analogy to make data management clear for all.
Sarah Taylor (PSC Biotech and ISPE Emerging Leader) and I duetted the final presentation of the day covering data integrity and data quality before the speakers, attendees and exhibitors all enjoyed a 2-hour networking reception where new friendships were formed and competitor rivalries were suspended for the duration.
Day 2 of the conference, chaired by ISPE Australasia Affiliate Vice-President Abdul Fneiche, kicked off with an extended session from Brandi Stockton (The Triality Group), co-lead of the GAMP AI Special Interest Group (SIG), sharing the framework and lifecycle approach for AI/ML developed by the SIG. After a caffeination break, the audience were treated to hearing both sides of a Low Code/No Code implementation project from Bob Buhlmann (AZ) and Manuh Pitasari (FactoryTalk, AZ’s implementation partner); this was a perfect example of leveraging critical thinking and creating an innovative approach to the control and validation of a very different kind of computerised system, exactly as GAMP 5 Second Edition encourages industry to do. Great work, Bob and Manuh!
The interest and engagement continued with Dr Andreas Hauser (AIQURIS) presenting his company’s solution to AI risk and vendor assessment (along with a little European-based humour that maybe the attendees missed but I certainly enjoyed as an expat).
There was no slump after lunch, thanks to Ben Sauer (AZ) actively showcasing the need for disruption to effect change (very useful for improving the design of paper aeroplanes), and how to use multiple roof shots as the precursors to the all-important moon shot. Dr. Brad Watmuff (Cortical Labs) brought a little ‘Frankenscience’ to the conference with talk of brain cells in a lab being ultimately trained to play the video-game Doom (something that adolescent boys seemed to manage with no training at all back in the day), and the final presentation was Ian Lucas (SeerPharma) sharing his history of involvement in digital innovation and his hopes for future collaboration.
But wait! There was more! Attendees got engaged and interactive during a panel discussion with Bob, Brad, Andreas, and Ian, moderated by Ben. It was a fantastic way to end the conference and judging by the responses, appreciated by the attendees.
Reflections
As always, serving on a conference committee takes time and dedication, and can be hard to juggle with a day job and hopes for a home life. COVID still managed to throw the plans off track, but flexibility and fast reflexes to build contingency plans got us over that particular hurdle.
Being the first time ISPE Australasia had hosted a conference around digital topics meant really starting from scratch in recruiting speakers, exhibitors and even attendees, and the conference committee members invested so much into the event.
Conference Committee L-R: Charlie Wakeham, Ben Sauer, Ian Lucas, Abdul Fneiche, Gerry McKiernan and Kerry Dranganoudis.
But the energy and engagement on the day showed that every effort is justified when you can bring opportunities and knowledge-sharing to our local industry. Looking at the feedback, phrases such as “Each presenter was knowledgeable and passionate about their topics”, “The agenda was well-structured and planned” and “Volunteer led and extremely professional” made it very worthwhile. My sincere thanks to the ISPE Australasia Board for the fortitude and dedication to make this event happen, and to all the amazing speakers.
Special thanks to the event sponsors and exhibitors:
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Written By: Charlie Wakeham, WakeUp to Quality
Practical Approaches to Data Integrity, 03 Dec 2018
The ISPE Australasia Affiliate hosted a 1 day Data Intergrity seminar in Sydney on 3rd Dec 2018. The day was led by one of our Australian Affiliate members, Charlie Wakeham, Waters Asia who has been instrumental in developing the recently (or soon to be) published ISPE GAMP Good Practice Guides - Data Integrity Key Concepts and Data Integrity for Manufacturing Systems.
Charlie provided a comprehensive overview of the guides in a fun and interactive manner. Each session was finished with a well thought out workshop, providing a hands on practical demonstration of the critical thinking associated with developing Data Integrity programs within an organisation.
We will be holding a reprise of this seminar in March 2019 in New Zealand for those who missed out.
Advanced Sterile Facilities and Design, 19-20 November 2018
The ISPE Australasia Affiliate collaborated with the Australian Chapter of PDA to bring an informative sterile seminar to Melbourne. The event was held at the Novotel on Collins over two days with Norman Goldschmidt, Genesis Engineers Inc. presenting.
Norm's presenting style was exceptional and he managed to keep the room engaged whilst navigating his way through topics from Regulatory Expectations, Cleanroom Design, Qualification and Optimisation, Cross-contamination Prevention and Advances in Aseptic Processing Technologies.
Our thanks go out to our 7 sponsor companies who provided support for the event and were present to show some of the new and existing services available within the Australian sterile manufacturing environment.
The overall feedback was excellent and some great discussion was held amongst the delegates. The TGA were present at the wrap up for both days, and with a well attended networking session held after the first day the opportunity for networking was great.
The seminar really drove home the importance of face to face meeting with industry peers as a means to share and transfer knowledge for our ultimate joint goal of providing Product Quality and Safety for Patients.
Thank you to our sponsors who helped to make the seminar a success:-
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Inaugural TGA GMP Forum, 26 June 2018
The ISPE Australasia Affiliate were delighted and honoured to be invited by the Australian Regulator, the Therapeutic Goods Administration (TGA), to participate in the organisation of the Inaugural TGA GMP Forum on 26th June 2018, in conjunction with three other pharmaceutical industry associations PDA, RACI and ARCS.
Benjamin Sauer, ISPE Australasia President and Helen Atkinson, ISPE Australasia Vice President formed part of the 12 person organising committee made up from members of each association and the Manufacturing Quality Branch (MQB) of the TGA. The committee were asked to provide guidance on content to be delivered by the TGA, and recommendations related to organisation and promotion of the event.
The event was a huge success with the registration closing 3 weeks early as we reached the maximum capacity of our venue at 450 delegates.
The 2018 GMP Forum was opened with an introductory session from Ben Noyen, Assistant Secretary, TGA MQB and Adjunct professor John Skerritt – Deputy Secretary, TGA Health Products Regulation Group, providing open and transparent communication on the TGA processes, fees and charges.
Following this, Jenny Hantzinikolas – Director, Inspections Section (IS), TGA MQB provided an overview of the TGAs participation in the Global GMP forums and committees, highlighting the important role that Australia plays in shaping the worldwide regulations for GMP. In particular the TGA have key roles in the Pharmaceutical Inspection Cooperation Schemes (PIC/S) which reviews, writes and recommends the Code of GMP adopted by many of the Asia Pacific regions. A key message from this session was that the TGA encourage industry feedback related to all areas of GMP, and the mechanisms for feedback were discussed and highlighted.
Stephen Farrell – Assistant Director, Licensing & Certification Section (LCS), TGA MQB discussed some of the changes and improvements made to the overseas GMP Clearance process, and highlighted some of the challenges faced in the current regulatory circumstances as other regulators are starting to also accept desk based certifications.
The day continued with TGA presenters from the MQB Inspections Section and the Licensing and Certifications Section providing updates on a variety of GMP issues and hot topics. Sessions in the afternoon were split between detailed GMP requirements for manufacturers focussing on the updated Australian Code of GMP released in January 2018 (based on PIC/S PE-009 version 13), and SME guidance particularly focusing on the role of the sponsor, for small and middle sized companies.
Finishing with a networking opportunity over a drink with our pharmaceutical industry peers, the event provided a great information session and a chance to catch up with familiar faces and meet some new contacts. The event was well supported by both industry and by the TGA, and provided plenty of opportunities to mingle and ask questions of inspectors outside of an audit scenario.
It is at events like these that you realise what an important role each of us can play in ensuring that the Australian Pharmaceutical industry continues to be identified as global leaders in providing the best quality Therapeutic Goods. The ISPE Australasia board look forward to participating in the next event.
Written by Helen Atkinson, ISPE Australasia Vice President
ISPE Event: Cleaning validation and contamination control practices - recent changes and risk based approaches
Stephanie Wilkins, Rebecca Brewer, Lynn Talomsin (TGA) , 04-05 May 2016, Sydney Olympic Park
On the morning of the 4th May 2016, 46 Australian and NZ industry delegates congregated at the Pullman Hotel in Sydney Olympic Park to meet and discuss recent changes to International Regulatory approaches to cleaning validation and contamination control. The morning session on Day 1 was opened by Australasia ISPE Vice President Ben Sauer, who welcomed the International and Interstate speakers as well as the course delegates who represented 26 different Life Science businesses from within Australia and New Zealand. Day 1 presentations began with Ms Wilkins outlining the International Regulatory landscape and recent changes however it did not take long for the seminar to move into the more detailed “nuts and bolts” of cleaning validation presented by Ms Brewer over the afternoon of day 1 and into day 2.
Ms Talomsin from the Office of Manufacturing Quality, TGA also presented an update on the current Australian Regulatory expectations in cleaning and contamination control before day 2 finished with short Q & A panel comprising the 3 speakers. The experience of industry delegates ranged from being very experienced to relatively new with respect to their knowledge in this important area. Several of the more experienced delegates were back for a refresher and to hear the very knowledgeable Ms Brewer present her views and technical approach in this area. Several delegates noticeably asked for very detailed guidance on some of the more technical elements of cleaning and these discussions benefited all participants. Very importantly, the less experienced delegates left with a sufficiently detailed information base for them to be able to progress the framework of a robust and defendable approach to cleaning validation within their own businesses.
The speakers are all experts in this area and we feel very privileged to attract them to Sydney just for this event. It was good to see and hear some of the differing views which led to some more very good discussions and interaction during the 2 day course. There was also a mix of hands on participative sessions such as the visual inspection of spiked SS coupons and then determining the detectability of different levels of surface contamination. All in all there were plenty of detailed questions being asked of the speakers which helped everyone to better understand this complex, but important topic.
The event was very well supported by both Industry and local Sponsors with a good interactive table top exhibit area for delegates to interact with each other and with local Suppliers of support products and services. The ISPE Committee thanks Ben Sauer for his drive in making this event such a success and providing great value for ISPE members and non-members alike.
Written by: Paul Fletcher, ISPE Committee