International QA Conference
DELEGATE BROCHURE
Quality
RE:UNITED BRIGHTON, 9TH 11TH NOVEMBER 2022
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Conference highlights
Presentations.
Open Discussions.
Panel Sessions.
Day International Conference.
Inspiring Location.
Stream types to suit all personalities.
Workshops.
MHRA Update.
Conference Social Events.
Quality
RE:UNITED BRIGHTON, 9TH 11TH NOVEMBER 2022
A word from our conference manager, Carl. We are back. And we missed you all. We’ve put a lot of effort into creating an event fit for our community and the times we live in. The location was relatively straightforward – Brighton is like an old friend to the Association and the Hilton Metropole is the perfect venue for what we have in store. As the world changed over the last two years, the conference will evolve with it. Our schedule has changed to include four key streams running throughout the event, giving delegates the opportunity to get as close or distant to the learning as they want. Of the four streams, only one is new – but the frequency of the other sessions will change. There will be more panel discussions and workshops, enabling as many people as possible to be more involved in the questioning and networking within a session. The Open Discussion stream will give delegates an opportunity to discuss hot topics and get opinions on matters close to their work. Our presentations will remain the cornerstone of the conference, but will be longer to really dive into a subject. The venue lends itself to these changes – dedicated rooms for each stream for ease of travel around the venue, and ample place to take a break and grab lunch. We want to enrich the event with different experiences – more posters, more space for exhibitors and our sponsors, a chance for delegates to have a professional headshot taken and a wellness room complete with a Mental Health First Aider. We recognise the conference is an investment in you – we hope that by providing as many opportunities to learn and network as we can in the two and a half days that we will see as many of our community as possible. Thank you to the Programme Committee and everyone involved in submitting abstracts to make this the most diverse conference we have ever held. Quality
RE:UNITED BRIGHTON, 9TH 11TH NOVEMBER 2022
KPIs in QA with the GLP Committee
Fraud: Do You Know What You’re Looking For? with Patricia Henley and Barney Horne
Quality on a Shoestring
led by Gillian Robson and The Research Practice Group
Quality
RE:UNITED BRIGHTON, 9TH 11TH NOVEMBER 2022
Description of PV System Management, Compilation, Oversight, Outsourcing led by Jana Hyankova and the PV Committee
Re:engage Workshops Interactive session where delegates will work on a given scenario/topic in groups and get feedback from moderators.
Roles and Responsibilites of Veterinary GCP in Field and Laboratory Studies with the Animal and Veterinary Products Committee
How Remote Working Has Changed
with the GLP Committee
Annual Audit Risk Assessment: Universe, Audits, Maintenance led by Jana Hyankova and the PV Committee
Data Integrity Risk Assessment - as easy as 1,2,3
led by Peter Connaughton and the GLP Committee
A word from programme committee chair, Cate. FINALLY! After waiting for two years, we are thrilled to be meeting face to face in 2022! For all of us, in some way or another, the world has changed radically since we met in Dublin in 2019. With the theme Quality Re:United, the Programme Committee has Re:Imagined and Re:Designed the conference. During the conference, there are more than 32 learning sessions, in workshops, presentations, panel and roundtable formats led by quality professionals. The event is not just to extend your knowledge but includes networking events to give you the chance to wind down, catch up and make new connections including opportunities to meet the RQA team, and RQA Committees who represent the membership. We are excited to be back and are looking forward to Re:Connecting with you! See you in Brighton. Cate Ovington Quality
RE:UNITED BRIGHTON, 9TH 11TH NOVEMBER 2022
Open discussions These sessions will follow the form of our Member Quality Conversatins (formally Coffee Mornings) and be made up of smaller groups who all join a discussion around these topics: GLP audit findings and responses Experiences of remote audits: a case study Building a QMS from scratch Big data, digital transformations and risk based approach for audits: a shifting paradigm Serious breaches An insight into, and learnings taken from, aRMM inspections Current best practices in PV auditing - how have things changed/moved on, any game changers? Quality oversight of collaborator/license partner relationships - what is expected? Vendor management: the risks and reward of getting it wrong or right. A Model of Quality – Is there a usable framework out there in addition to standards & definitions
Quality
RE:UNITED BRIGHTON, 9TH 11TH NOVEMBER 2022
A word from our chair, Tim. After two long years of interfacing with colleagues and clients through a screen, the RQA conference in Brighton provides a wonderful opportunity to meet face to face again, Hooray. The design of the programme, as well as presentations from SMEs on many of the current key issues that impact on the implementation of the GxP across our global industries, has been specifically designed to provide many opportunities for delegates, friends and colleagues to meet and discuss informally those issues that they are important to them. The conference promises to be a rebirth of the traditional face to face International QA Conference with the emphasis on re:connecting. I am very excited at the prospect of this face to face conference and meeting many of you in Brighton to enjoy the exceptional programme being offered. Tim Stiles
Quality
RE:UNITED BRIGHTON, 9TH 11TH NOVEMBER 2022
Re:flect with Presentations The traditional conference presentation - listen to our speakers and ask questions at the end. Our amazing faculty have come up with some thought-provoking topics for you to re:flect on and ask questions in real-time. New Technologies: How Do We Adopt Them Quickly and Easily Impact of Revised OECD Advisory Document on Quality Assurance and GLP Master Schedule: GLP Compliance Requirements and Business Needs
Implementing DMAIC Tool of Lean Six Sigma in PV Risk Management Activities Leveraging Automation e Consent Quality
RE:UNITED BRIGHTON, 9TH 11TH NOVEMBER 2022
Quality Culture - A Foundation of Qualityby-Design The Future of QEM: Self-Investigating CAPAs
Quality Culture - More Than Just Behaviours Developing Quality-United we stand, divided we fall The Future of QEM: Self-Investigating CAPAs Data Integrity Compliance Planning Implementing GCLP Compliance for HIV-1 Vaccine Clinical Trials in Africa
ISPE GAMP5 Second Edition and the ISO25010 and ISO 27001
Pharmacovigilance Quality Management System Oversight: Partnering Quality and PV Operations
Trends in PV Inspection Findings and the Challenges of Remote Inspections
QA Inter-Site Collaboration to Optimise QA Resources
When Pharma Incorporates IVDs: A Dynamic Unification
Informed Consent: How The Industry Evolves to Improve Patients Rights
Does our QMS Need ISO 9001?
SALSA (Statistical Assessment Layer for Site Audits)
Re:acquaint at the i360 To mark the return of the face-toface International QA Conference we have arranged for registration to take place at the iconic British Airways i360 on the evening of Tuesday 8th November. Glide up to 450ft in the glass pod and enjoy panoramic views over the bright lights of Brighton. Included in your conference package, please secure your flight when booking your conference place.
Quality
RE:UNITED BRIGHTON, 9TH 11TH NOVEMBER 2022
Panel discussions Our panel discussions will give different points of view on a topic, while allowing time to question and probe the panelists further. Take the time to hear what other professionals in your field are saying.
Impact of Covid 19 and Ways of Working with Thana Subramanian, Keith Thornley and Virginie Wieter (Computing Committee) Quality Conscience: Do the Right Thing (World Quality Week) New Regulation Impact on Veterinary Clinical Trials with the Animal & Veterinary Products Committee GLP/GCLP Question Time with the GLP Committee GCP Clinic with the GCP Committee More to be announced.
Quality
RE:UNITED BRIGHTON, 9TH 11TH NOVEMBER 2022
Re:union l l a B
Location: Empress Suite, The Grand, Brighton Time: 7.00pm for drinks, 7.30pm sit down for dinner
An evening of fun, fizz and neon lights! Don’t miss the Re:union ball - some would say the highlight of the week, and this year will be no different. Re:connect, re:unite and dance the night away to music by a new band for 2022, Pulse.
Wine kindly sponsored by RiverArk
Quality
RE:UNITED BRIGHTON, 9TH 11TH NOVEMBER 2022
our platinum sponsors It’s reassuring that Sparta Systems has sponsored RQA’s International QA Conference and the European QA Symposium is 2022; RQA is exceedingly grateful for their support. We look forward to working alongside Sparta Systems and further collaborating on these world-class events.
Sparta Systems, a Honeywell Company, brings leadingedge quality management solutions to regulated industries. With TrackWise® and TrackWise Digital®, Sparta provides enterprise and cloud-based QMS software solutions that help companies go to market faster and deliver the highest standards for product quality, compliance and customer satisfaction. Sparta is an innovator in its field and is driving smart quality with first-of-its-kind AI-enabled quality solutions. By applying the latest digital technologies, our products simplify the process of quality management and guide customers toward proactive quality. The combination of Sparta Systems and Honeywell brings together Sparta Systems’ quality management leadership with over 100 years of industrial and software expertise from Honeywell. Together, Sparta and Honeywell will shape the future of digital quality and operational excellence for the life sciences industry.
www.spartasystems.com
Quality
RE:UNITED BRIGHTON, 9TH 11TH NOVEMBER 2022
Sparta said: “Sparta Systems, A Honeywell Company, is pleased to be partnering with RQA again in 2022. We are looking forward to being a platinum sponsor for RQA’s International QA Conference and the European QA Congress. RQA has a vision to inspire quality, integrity and compliance in scientific research. Sparta Systems are thrilled to support the vision and have the opportunity to engage with attendees at RQA’s events, which nurture discussions around quality assurance and compliance. RQA provides this with its interactive event platform, which enables networking with a mix of panel discussions, workshop sessions, exhibitions and more. We are looking forward to our continued partnership with RQA in 2022.”
our gold and silver sponsors RiverArk is a Boutique Quality Consultancy uniquely positioned to offer tailored services with capabilities extending globally. We are nimble and adaptable, our services bespoke, flexible and scalable and our reach local as well as international. We are not generalist’s quality consulting company instead we offer niche expertise in GxP quality consulting. This makes RiverArk a truly independent consultancy in providing services that eliminate conflict of interest for our clients. Why RiverArk: • Bespoke Solutions – Efficient & pragmatic services relevant to your needs. • Niche Expertise – Specialists focusing strengths on doing an effective job. • Collective Experience – Consultants with decades of experience from different geographies. • Flexibility – A small core team plus a pool of subject matter experts makes RiverArk highly nimble and flexible in its approach. www.riverark.co.uk
gold
Vault Quality: Seamlessly manage your quality processes and content with the Vault Quality suite of applications. All parties – life sciences companies, contract manufacturers, and suppliers – have access to a single authoritative source, enabling greater visibility and control. Vault Quality enables organizations to modernize quality management, assuring quality while driving compliance and operational innovation. Veeva Development Cloud brings together applications for clinical, regulatory, and quality to help organizations eliminate silos and drive end-to-end business processes across product development. Today, product development applications are siloed and not well integrated. Multiple systems create inefficiencies and slow down critical business processes. Veeva is the first and only company to offer suites of unified applications on a single cloud platform across the entire product lifecycle. With all applications on the Veeva Vault Platform, companies can streamline product development information across regions and departments for greater efficiency and compliance. www.veeva.com/eu
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MasterControl Inc. is home to the most connected, intelligent, and dynamic quality management system for life sciences and other regulated industries. Our mission is to help our customers bring life-changing products to more people sooner. Learn how to take a smarter approach to quality at mastercontrol.com. www.mastercontrol.com
With thanks to our platinum, gold and silver sponsors, without sponsorship the event could not take place.
Arriello is a leading consultancy and solutions provider of risk management and compliance services to the pharmaceutical industry.
gold
https://arriello.com/quality-assurance-and-auditing
silver
Quality
RE:UNITED BRIGHTON, 9TH 11TH NOVEMBER 2022
Let’s get re:united in Brigton www.therqa.com/conferences/2022-international-qa-conference