RQA2023 Delegate Handbook

Breaking the ice Exploring the depths of quality RQA International QA Conference 1st - 3rd November 2023, ICC Belfast

delegate handbook platinum sponsors #RQA2023

thanks to our platinum sponsor

www.spartasystems.com

download the conference app

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Welcome to RQA2023 “We are privileged to welcome everyone to Belfast, so be inspired by the history, culture and heritage, not least the Titanic heritage. We want you to be inquisitive and get into the spirit with breaking the ice, exploring the depth of quality. We have a lot to share with you in the programme and hopefully much that you can take away with you to your organisations. From this historic place, we are looking forward and seeing the next revolution and what that means for quality.

We are excited about the programme that the team have put together, you’ll notice its slightly different in places, so there is something for everyone. Please also look out for the new development routes - Learn, Develop and Extend.

The programme includes a prestigious line up of speakers from around the world and our Keynote speaker Prof Sir Jonathan Van-Tam. I hope like me you are looking forward to a candid perspective from the tragic events of the last couple of years from Prof Sir Jonathan Van-Tam in contrast to the political circus we experienced.”

Yasser Farooq, 2023 Programme Committee Chair “On behalf of the RQA office I’d like to welcome you to this year’s RQA Conference. This is the culmination of a year’s worth of hard work by so many people. We are thankful to all the faculty for their time and effort to help make this event such a widely anticipated one. I’d also like to thank all our sponsors and exhibitors for their investment into the event – as a not-for-profit organisation, this revenue is crucial in being able to stage this event at the level that benefits our community.

I’d especially like to thank everyone in the RQA office – it is incredible that everything you see, eat, drink, dance to or have your photo taken by has been organised by such a small group of people. I see how much effort goes into making sure this week runs as smoothly as possible and am always grateful for the extra effort to get us over the line each year.

I hope you enjoy the event as much as we enjoy organising it.”

Carl Lummis-Blaxell, RQA Conference Manager “Welcome to the 2023 RQA International QA Conference.

We have a full and exciting programme for you to enjoy over the three days of the conference.

Full details of the programme can be accessed via the conference app, Whova, for the event. This app will keep you up to date with all the events and activities during the conference as well as enabling you to contact other attendees.

Enjoy the conference and experience what Belfast has to offer visitors.”

Tim Stiles, RQA Chair

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need to know session types This year we have a variety of sessions running throughout the event: presentations, workshops, panels and social learning (workshops, topical tables).

conference app We are using an app called Whova this year, this can be downloaded in your app store. Simply search for ‘2023 RQA International QA Conference ‘.

join the conversation Use the #RQA2023 hastag on LinkedIn or X (formerly Twitter) to join the conversation. Posts will be shown in the conference app.

Q&A This year Q&A and polls will be available through our conference app.

wifi Network name: ICCBelfast Password: No password requred

games We have two games running throughout the conference, the leaderboard within the conference app and also the normal exhibitor competition (please see page 13 of this handbook).

slides Slides, where permission has been granted, will be available within the app.

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help If you need any help during the conference please visit either the RQA stand (exhibition area) or the information stand on Level 1. We will also be available on conferences@therqa.com throughout the event.

certificates Certificates will be available for all delegates and will be emailed after the event.

feedback We really appreciate your feedback on the conference and are especially interested in how you found the new session formats. Feedback can be accessed by scanning this QR code.

Quiet Area We have a dedicated quiet area run by EventWell located on Level 2.

If you want to chat to someone, are feeling overwhelmed or just want to escape the crowds of the conference for a few minutes, head down there to reinvigorate your senses.

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MAP

level 1

Plenary sessions Exhibition area Headshot area RQA info desk

level 2

New to QA Sessions Quiet room

level 3 Sessions

programme WEDNESDAY 1st November 2023

for a detailed and up to date programme, see the conference app

Hall 1A

Meeting Room 1

Meeting Room 2

Meeting Room 3

Board Room 2

07.30

Registration opens, Riverside Foyer. Exhibition area open for tea and coffee (Hall1BCD)

08.30

Conference welcome, RQA and Honeywell

08.40

Breaking the ice with AI: because even life sciences need a robot overlord - exploring new depths of quality assurance, Fabrizio Maniglio, Honeywell

09.30

Keynote - science meets policy, Prof Sir Jonathan Van-Tam 10.30 NETWORKING BREAK, HALL1BCD (EXHIBITION AREA)

11.00

Regulators update and questions 12.30 LUNCH, HALL1BCD (EXHIBITION AREA)

13.30

14.15

Issue management and SB reporting in the digital world – focus on system issues and data integrity

Building the plane as we fly it

Navigating open source software technologies in GXP regulated environments: key insights for qa representatives

Maintaining pharmacovigilance compliance in an increasing complex regulatory environment

Impacts of veterinary medicines regulation 2019/6 on regulatory activities in the UK

DCTs and the evolving regulatory acceptance

What is digital innovation and how can quality organisations leverage emerging technologies to support fast changing landscape

Going off script: breaking away from traditional csv test scripts with alternative risk-based approaches from GAMP 5 2nd edition and FDA computer software assurance

PV regulatory intelligence oversight

Advanced monitor training session 1 - remote monitoring and auditing

15.00 NETWORKING BREAK, HALL1BCD (EXHIBITION AREA) SOCIAL LEARNING SESSIONS

15.30

Topical tables

Navigating uncharted waters: AI-driven risk management in life sciences

ICH-GCP draft updates and potential impact workshop

What does a learnercentric experience look like in a gxp world?

Workshop

Advanced monitor training session 2 - sponsor oversight/ outsourcing/risk based monitoring

17.00 END OF DAY 1

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THURSDAY 2nd NOVEMBER 2023 08.00

Hall 1A

Meeting Room 1

Diversity and inclusion in STEM

Why don’t they do what we ask them to do?! The human factor in quality improvement

Meeting Room 2

Meeting Room 3

08.45 NETWORKING BREAK, HALL1BCD (EXHIBITION AREA) IT QA clinic and regulatory update

PV QA clinic and PVAO audit process efficiency solution

09.00

GCP QA clinic

11.00

Detecting and preventing fraud and misconduct in a virtual world

Risk based process auditing approach

Computer system validation (CSV) and cybersecurity throughout technology lifecycle

Ensure anytime inspection readiness by implementing quality circle

11.45

Serious breaches - new European requirements

PMDA and sponsor GLP inspection conducted in Japan under the pandemic

AI how to validate it for GXP purposes in real life

Japanese pharmacovigilance audit activity - new tide of quality assurance

13.30

ICH E8 R1: the renovation of GCP Communication skills of an - a framework to support clinical auditor workshop trial implementation

Hyperbole of AI

14.15

Exploring the globe or stuck in the mud: ensuring your QMS vehicle is best positioned to reach its quality destination

Harnessing the power of open source and open standards through the use case of Aranei and Sonadorai

GLP QA clinic

10.30 NETWORKING BREAK, HALL1BCD (EXHIBITION AREA)

12.30 LUNCH, HALL1BCD (EXHIBITION AREA)

The consultant’s life - exploring the 90% below the surface

15.00 NETWORKING BREAK, HALL1BCD (EXHIBITION AREA) SOCIAL LEARNING SESSIONS 16.00

How can we embed data Training and performance where DCTs and the evolving analytics capabilities within drug is the missing link regulatory acceptance development quality?

Topical tables

END OF DAY 2 19.00 TITANIC DRINKS RECEPTION AND DINNER DANCE, RIVERSIDE FOYER, ICC

FRIDAY 3RD NOVEMBER 2023 Hall 1A

Meeting Room 1

Meeting Room 2

08.45 FDA BIMO 09.00 09.30 09.45

Risk management from an audit perspective

Breaking the status-quo: an effective approach for supplier management in clinical research

Left out in the cold - deep dive on supply chain disruption and potential mitigation MHRA/EMA/FDA - ICH E6 R3 How advanced quality event management optimises resources and saves your bottom line

10.00

QRM and quality - making sure fear doesn’t undermine your QRM programme

10.30 NETWORKING BREAK, HALL1BCD (EXHIBITION AREA) 11.00

Ask us anything - RQA Committee and SIG Chairs

12.15

Conference close and awards 12.30 END OF CONFERENCE

new to qa programme - Day 1 Hall 1A

Board Room 1

08.30

Conference welcome

08.40

Breaking the ice with AI: because even life sciences need a robot overlord - exploring new depths of quality assurance

09.30

Keynote address - when science meets policy 10.30 NETWORKING BREAK, HALL1BCD (EXHIBITION AREA)

11.00

Regulators update and questions 12.30 LUNCH, HALL1BCD (EXHIBITION AREA)

13.30

Welcome session - breaking the ice

14.15

Quality systems - a view from the crow’s nest 15.00 NETWORKING BREAK, HALL1BCD (EXHIBITION AREA)

15.30

Topical tables 17.00 CLOSE OF DAY 1

Day 2 Hall 1A

Board Room 1

09.00

New to QA, a guide to keeping you afloat. Part one 10.30 NETWORKING BREAK, HALL1BCD (EXHIBITION AREA)

11.00

Keeping your cool in QA - workshop 12.30 LUNCH, HALL1BCD (EXHIBITION AREA)

13.30

ALCOA: just the tip of the iceberg workshop 15.00 NETWORKING BREAK, HALL1BCD (EXHIBITION AREA)

15.30

Topical Tables 17.00 CLOSE OF DAY 2. 19.00 TITANIC THEMED DINNER AND DANCE, RIVERSIDE FOYER, ICC

Day 3 Hall 1A

Board Room 1

09.00

New to QA, a guide to keeping you afloat - part two 10.30 NETWORKING BREAK, HALL1BCD (EXHIBITION AREA)

11.00

Ask us anything - a chance to ask RQA committee chairs and SIG chairs your questions

12.15

Conference close and awards 12.30 END OF CONFERENCE

our sponsors Without our sponsors we could not run these events and we are grateful for their support. Please take the time to visit the sponsors in the exhibition area.

platinum sponsor

Honeywell delivers industry-specific solutions that include aerospace products and services; control technologies for buildings and industry; and performance materials globally. Our technologies help aircraft, buildings, manufacturing plants, supply chains and workers become more connected to make our world smarter, safer and more sustainable.

Honeywell’s life sciences solutions provide companies with unparalleled quality and operational insights. Through process automation and seamlessly connecting data across the life sciences value chain, we harness the potential of cutting-edge digital technologies and predictive analytics to speed decisions and the delivery of innovative products. Our mission is to guide life sciences enterprises, regardless of their scale or digital evolution phase, towards delivering safer products, enhancing business and patient outcomes and upholding rigorous regulatory compliance standards. For more news and information on Honeywell, please visit www. spartasystems.com.

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 10

GOLD sponsor MasterControl Inc. is a leading provider of cloud-based quality and compliance software for life sciences and other regulated industries. Our mission is the same as that of our customers – to bring life-changing products to more people sooner.

Use the MasterControl Quality Excellence™ solution to digitise, automate and connect quality and compliance processes with a closed-loop system that embeds quality into every step of your product life cycle – from concept to commercialisation.

When you use our solutions to eliminate antiquated, paper-based processes, compliance is simpler, issues are preventable, and you can get your products to market faster.

Join over 1,000 companies worldwide that use our solutions to achieve new levels of excellence across product development, clinical trials, regulatory affairs, quality management, supply chain, manufacturing and postmarket surveillance. Learn more at mastercontrol.com.

GOLD sponsor RiverArk is a Global Quality Consultancy uniquely positioned to offer tailored services in GxP Consulting and Auditing. We are nimble and adaptable, our services bespoke, flexible and scalable and our reach local as well as international. This makes RiverArk a truly independent consultancy in providing services that eliminate conflict of interest for our clients. Our clients range from small or start-up to large Pharmaceutical, Biotechnology and Medical Device companies based worldwide. RiverArk’s expertise spans working across organisations with very young or scarce quality management systems, as well as very mature organisations with established quality cultures. RiverArk has ‘hands on, on the ground’ experience in over 60 countries. We are well equipped to work on planned projects, as well as ad-hoc and urgent rescue projects. We provide value to you by delivering customized consultancy solutions per your business need. We have a large, global team of highly qualified GxP consultants with an average of 15 years of QA experience who strive to provide precise auditing, valuable in-depth consulting and training across industry. With varied backgrounds, multinational positioning, wide-ranging education, subject matter expertise and industry experience, RiverArk’s consultants are well suited to provide the expertise, skills and objectivity to evaluate, build or improve your quality systems and compliance.

silver sponsor Arriello is a leading consultancy and solutions provider of risk management and compliance services to the pharmaceutical industry. We’ve been making the development-to-market process faster, better, and smarter since 2008.

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DINNER DANCE Join us for the Titanic themed dinner dance, 2nd November 2023 Drinks reception in the Riverside Foyer (registration area) from 7pm, followed by a three course dinner from 7.45pm, entertainment (string quartet, band, photo booth, magician) and dancing.

RQA Stand Self-serve coffee machine More info on RQA

Headshot Area Get a free headshot by Josh on Level 1

Have your say

SAVE THE DATE RQA INTERNATIONAL QA CONFERENCE 2024 HILTON BRIGHTON 6th - 8th NOVEMBER 2024 12

exhibitor competition Win an Amazon Echo Show.

Collect a stamp from each of the exhibitors and sponsors below, remove this page and submit your entry to the RQA stand/information desk by 9am on Friday.

HONEYWELL

MASTERCONTROL

RIVERARK

SOFAQ

TOWER MAINS

PROCLINICAL

FDAQRC

HOBSON PRIOR

CARITAS QUALITY

IDEAGEN

THE CQA COMPANY

ADAMAS

GQMA

QUALOGY

JSQA

SQA

JAF CONSULTING

OBELYSQ SA

GXP ENGAGED

SIMPLOUD

SEGCIB

ZIGZAG

BARRINGTON JAMES

DARQA

CQAF

HANNAH AND ASSOCIATES

DB ALLIANCE

DOT COMPLIANCE

RQA

ARRIELLO

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exhibitor competition Win an Amazon Echo Show.

Collect a stamp from each of the exhibitors and sponsors.

Remove this page and submit your entry to the RQA stand/information desk by 9am on Friday.

Name: _____________________________________________________ Company: ___________________________________________________ Email address: _______________________________________________

Thank you for your entry.

We will be in touch to let you know the if you have won.

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your conference notes

Based in Edinburgh, we provide international QA services

“Where quality doesn’t begin and end with audit” Tower Mains offers bespoke audit, consultancy, training, and quality assurance services to the clinical, healthcare, life sciences, biotechnology, and scientific industries. Our diverse team has over 200 years of global regulatory experience, and as a company, we have worked with over 450 organisations in GLP, GCP, GMP, GCLP and non-regulated research.

Auditing

Quality Services

We have the capability to support your entire regulatory audit

We are proud to offer flexible, credible, and cost-effective quality

programme from early development to post-market surveillance.

assurance support services when and where you need them.

Consultancy

Training

Advice, information, and consultancy

We provide in-house and online

are always provided with

training covering a wide range of

consideration as to how you are likely to use it in your situation,

topics relating to the regulatory industry and self-development.

With our extensive knowledge, we assess your unique situation and tailor our services accordingly to meet your requirements, offering a personalised service that is highly regarded by our clients.

example@example.com www.towermains.com

info@towermains.com

+44 (0)131 450 7017

Come visit us at booth 10!

FDA QUALITY & REGULATORY CONSULTANTS

Your One Stop Shop for Global Quality & Regulatory Compliance G L O B A L E X P E R T I S E | fdaqrc.com

Qualogy is a GxP regulatory archive and is run by an experienced team whom together have over 35 years’ experience in the industry. We pride ourselves on our high-quality service creating a professional yet personalised approach to handlinig your data. At Qualogy we understand the importance of your data and therefore we do not just see a box - we value its importance.

The Archive Our stand-alone archives are designed for security and protection of your material, with temperature and humidity-control and fire protection. With multiple quality checks we ensure accuracy, professionalism and security every time.

The Service: Our experienced and trained Qualogy drivers offer a door-to-door courier service from anywhere in Europe. As a dedicated Regulatory Archive, Qualogy has exceptionally high standards and vast knowledge of the GxP regulations. We can adapt our services to support your business needs, providing a unique and efficient customer experience.

Contact us today to find out more 01933 357953 | archives@qualogy.co.uk | www.qualogy.co.uk The Archivist, Qualogy Ltd, Po Box 6255, Thrapston, Northamptonshire, NN14 4ZL

C O L L A B O R AT I O N . C O N F I D E N C E . A S S U R A N C E .

LEADING THE WAY IN QUALIT Y ASSUR ANCE AUDITING AND CONSULTANCY SERVICES FOR OVER 25 YEARS OUR SERVICES

GOOD CLINIC A L PR AC TICE (GCP)

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GOOD M A NUFAC TURING PR AC TICE (GMP)

COMPUTER S YS TEM COMPLI A NCE (C SC)

GOOD L A BOR ATORY COMPLI A NCE (GLC)

MOCK INSPEC TIONS

QMS CONSULTA NC Y

SOP DE V ELOPMENT

REMOTE SER V ICES

WORKING IN OVER 100 COUNTRIES WITH OVER 750 GLOBAL CLIENTS FIND US AT STAND #18

Unlock Tailored Compliance Solutions: Contact Us or Download Our Brochure Today W W W. ADAMA SCONSULTING.COM

CONTACT US

BROCHURE

Maintain compliance and improve quality assurance Maintain compliance with industry standards Manage documents centrally and securely Anticipate and manage risks with robust CAPA workflows Streamline audit reporting and management Enable continuous improvement and operational excellence

www.ideagen.com/solutions/quality /quality-management

FIND US AT STAND

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Quality People make Quality Teams

Looking to grow your team?

Hobson Prior’s specialist recruiters have been delivering made-to-measure recruitment solutions for over 20 years.

With expert clinical quality networks globally, supporting audits, inspection readiness activities or QMS efficiency, we will help you find the right people so you can focus on your projects.

CONTACT THE TEAM: E: QUALITY@HOBSONPRIOR.COM T: 01892 612 612 W: HOBSONPRIOR.COM/QUALITY

Your Global Growth Partners Since 2005, we have been providing award-winning recruitment solutions exclusively within the life science industry.

We support the growth of individuals, teams, and whole organizations through our tailored executive search, workforce solutions, and staffing services.

We deliver on every stage of the process Discovery & Preclinical

Regulatory Affairs

Clinical Development

Clinical Operations

Drug Safety

Quality Assurance

Biometrics

Data Science

Medical Affairs

Access & Reimbursement

Sales & Marketing

Commercial Operations

Procurement & Supply Chain

Engineering & Manufacturing

Enabling Functions

Digital & IT

>1m

>350k

life science professionals in our extended global network

screened and qualified life science professionals on our database

www.proclinical.com

>10k professional vacancies filled

www.therqa.com