Two Day Programme

Where We're Going, We Don't Need Roads or Documents: AI and the Future of Quality Assurance

The quality assurance (QA) landscape faces unprecedented challenges and opportunities in an era where technology advances faster than regulatory updates. This presentation explores the revolutionary potential of Artificial Intelligence (AI) in redefining quality assurance from the ground up. Inspired by the visionary essence of "Back to the Future," we look to integrate first principles thinking to redesign QA processes in the life sciences sector from the ground up with AI in mind. We will delve into the fundamental concepts of QA and examine how AI can be leveraged to meet current compliance standards and anticipate future regulatory landscapes. The discussion will focus on redesigning traditional systems using AI-driven models, which promise greater efficiency, accuracy, and adaptability. Furthermore, this presentation will address potential challenges and ethical considerations as AI becomes more ingrained in our quality systems. The goal is to equip QA professionals with a roadmap to harness AI technologies that propel the industry forward, ensuring that our future in quality assurance is compliant but also innovative and sustainable. Join us as we step into a future where our paths are uncharted but more promising than ever, driven by the power of AI in quality assurance.

Data and Artificial Intelligence (AI) Ethics - Implications for R&D Quality

This session begins with defining what AI and Data Ethics entail and how they relate to the principles and regulations that govern R&D Quality.  Practical advice for implementing and utilising these principles will be explored in the context of R&D Quality. Also included is a discussion on how the principles can inform and guide activities such as audits and risk assessments.

Evaluating AI Driven Medical Imaging Systems: A Deep Dive into Architecture, Security, and Audit Trails

This session for senior QA professionals will explore the architecture and security mechanisms of AI driven medical image analytics systems, focusing on authentication protocols, security and audit trail compliance. It aims to provide a comprehensive understanding of system design and operation, enhancing the ability to assess and improve these complex systems.

AI-supported TMF: Validation and other Challenges

AI-empowered eTMF becomes the routine in clinical trials. There are different answers to the questions regarding it's validation and usage. Let's discuss the possible answers.

Quality 4.0 - A Working Definition and Principles (from research)

I will provide the attendees with the opportunity to benefit from the leading research carried out by Leeds University Business School, The Oakland Institute and the CQI, to understand more about Quality 4.0 and its implications for the quality profession The presentation will cover:

• How the research team developed a simple working definition of Quality 4.0
• Eight emerging core principles that will assist the professional to think about how digital transformation will impact quality management practice in their own organisation
• The relationship between the new Q 4.0 Principles and the ‘standard’ quality management principles (e.g. from ISO 9000 series)
• Important impact and practices discoveries from the research project
• Implications for professional capability and practice development.

At the end of the presentation, each participant should be able to articulate a working definition of Quality 4.0 and be more prepared to engage in discussions about how it will influence the approach to quality management in their organisations.

The future of neurocinclusion and mental wellbeing in the workplace

A session that will delve into the future of work and how neuroinclusion and mental wellbeing will lead the way in new working practices, policies and procedures. We will also visit how psychological safety and security will be an essential key metric taking neurodiversity from a misunderstood nice to have, to an essential must have for all businesses and employers.

Exploring the Power of AI and ML in Revolutionising Preclinical Study Auditing

AI and ML can transform preclinical study auditing by automating data analysis, risk assessment, and document review. These technologies helps in recognising patterns and anomalies in large datasets, allowing auditors to focus on more critical issues. Through predictive analytics, ML models assess and prioritise risks, enabling a more targeted auditing approach. Overall, AI and ML enhance auditing efficiency, resource allocation, and compliance assurance by providing data-driven insights and adapting to evolving industry dynamics.

Disappearing Roles: The Impact of Technological Development on QA Positions

This presentation will elucidate the impact of modern technology on the development of the Quality Management System (QMS) within the company. The increase in efficiency and productivity, coupled with cost savings, manifests as surplus manpower, affecting the workforce overall. To mitigate any negative impact, existing positions within QA are evolving, necessitating additional skills and knowledge in the field of IT.

Considerations Specific to Computer System Validation of an Artificial Intelligence Tool

(1) Computer System Validation (CSV) is a critical process that ensures the integrity, reliability, and compliance of computer systems, including artificial intelligence (AI) tools.(2) We aim to discuss the key points to consider for CSV of AI-driven technology tools and database.(3) We aim to share potential examples and templates to provide a better understanding of CSV methodologies for AI tools.

Writing and responding to audit comments: A view from the Auditor and Auditee perspectives in the GLP environment.

Better ways of writing and responding to audit comments. Common errors and how to improve. For GLP Auditors, Study directors, Managers and Staff.

Are the regulatory goal posts moving? - the benefits and potential pitfalls of OECD GLP Position Paper 24

Discussion regarding the perception of 'regulatory creep' across GxPs. This will look at QI tools suggested in OECD GLP Document 24 and the potential benefits and pitfalls.

A Holistic Approach and Maintaining Compliance in an Evolving Pharmacovigilance Environment

Pharmacovigilance is evolving rapidly and establishing compliance management is one of the companyâs responsibilities. The evolution of the pharmacovigilance landscape promises exciting advances supporting earlier detection of adverse events and the risk benefit evaluation of medicines for patients and the current process for monitoring of compliance across the system need be adjusted accordingly.

Navigating Quality Risk Management and Audits in Pharmacovigilance: Ensuring Drug Safety and Compliance

(1) To explain how a synergy can be built between quality risk management (QRM) and audits for better efficiency and compliance in the pharmacovigilance universe. (2) To display how quality risk management can guide for a focused and effective audit conduct, which leads to better compliance.

The Human Touch: Elevating Quality Improvement in Day-to-Day Drug Safety Monitoring

In the ever-changing field of drug safety monitoring, where technology is a major factor, it is important to remember that people are invaluable. This article explores the role that human interaction plays in quality enhancement in routine drug safety monitoring operations. We examine the ways in which the human factor enhances the overall standard of drug safety processes, from cultivating a culture of vigilance to utilising knowledge.

Evolving Quality: Unleashing Ecosystems in Life Sciences

This presentation explores the transformative impact of a data fabric ecosystem in the life sciences industry's quality management domain. It highlights the significance of data fabric architecture in integrating diverse data sources, thereby improving data accessibility and optimising management practices. The presentation will explore how this integration leads to refined processes and elevated industry standards.The talk emphasises the crucial role of real-time data analysis within the data fabric ecosystem, which is pivotal for quick decision-making in quality management. It underscores how this agility enables professionals to adapt to changing compliance landscapes, thus improving the quality of science products. The presentation will also discuss the synergy between continuous improvement, innovation, and adherence to quality driven by this efficient ecosystem.

How AI is revolutionising clinical trials

The integration of AI into clinical trials holds great promise for revolutionising various aspects of the research process, ultimately leading to more efficient, cost-effective, and personalised approaches to healthcare.

Checklists - a blast from the past, or an invaluable part of a risk-based QA programmes?

Discussion regarding the suitability of audit checklists in the current risk-based environment. Primarily from a preclinical perspective, but applicable across GxPs.

The Evolution of GLP and Its Impact on Business

The presentation will explore how the changing expectations with respect to GLP requirements has impacted business operations and decisions. The potential impacts on businesses in the future particularly with regard to emerging technologies, including AI, will be discussed. Both the positive and the negative impacts of GLP will be explored.This presentation aims to increase awareness of the impact that the interpretation of GLP requirements has on businesses.

The Implementation of Non-Regulatory Equipment in Regulatory Environments

In the rapidly evolving landscape of clinical research, the integration of non-regulatory equipment into regulated clinical laboratory settings is becoming increasingly crucial. This one-hour workshop/presentation offers a focused exploration into the challenges and strategies associated with aligning non-regulatory equipment within the laboratory. Our objective is to provide participants with actionable insights into navigating the regulatory requirements, conducting effective risk assessments, and developing compliance strategies that ensure the seamless incorporation of innovative equipment into their laboratory operations.

Pharmacovigilance Agreement Optimisation (PVAO)

An overview of TransCelerate’s Pharmacovigilance Agreements Optimisation (PVAO) Initiative, which includes a suite of solutions aimed at assisting organisations in improving their PVA process. These solutions have the potential to enable organisations in optimising processes and achieve more efficient negotiations with business partners globally.

Traditional audit did not work – we need a new approach!

Many non-compliances have been reported recently in Japan. The regulator moved toward strengthening their inspections. Root cause exists in different spot which the regulators are focusing.

Integrating Quality Risk Management methodology into the organisations quality management system for better regulatory compliance

Presenting a case study on how to integrate quality risk management into the quality management system of the organisation for achieving regulatory compliance in pharmacovigilance

The Growing Need for Digital Transformations to expedite product QA reviews and batch certifications

In today's pharmaceutical landscape, manual batch certification processes persist, causing inefficiencies and substantial financial losses. This presentation advocates for the adoption of emerging AI-based technologies to automate these processes, outlining their potential to streamline quality assurance reviews, reduce regulatory risks, and deliver tangible benefits to pharmaceutical organisations, ultimately fostering a more efficient and reliable industry. Case studies will be presented to illustrate the transformative impact of these technologies.

Exploring the Synergy of Artificial Intelligence, Animation, and Gamification in GxP Training

This presentation explores the potential synergy between artificial intelligence, animation, and gamification in GxP training. It provides practical insights into how these technologies can be effectively integrated to enhance the training experience. The presentation focuses on practical examples and real-world applications, offering valuable insights for organisers seeking to leverage these innovative approaches in their training programmes.

The Future of On-the-Job Training - New Modalities based on an Old Idea

On-the-Job Training (OJT) is back! With inspectors looking for evidence of competency rather than just documented compliance, use of OJT is increasing again. Thanks to progress in learning technology and unification of business processes, OJT can now be more efficient, more engaging and more effective than ever before.

Failure Mode Effect Analysis (FMEA): An effective tool for Risk Based Assessment of GLP QA Programmes

Failure Mode Effect Analysis is a valuable tool for prevention and improvement of any product, processes, services, or system. This analysis allows an organisation to assess the effect of every potential failure according to the severity of the effect, the probability of the occurrence and the detectability of failure.

Shaping the Future: Prioritising Continuous Evaluation and Quality-Centric Risk Management in Non-Clinical Studies

The presentation will emphasise the importance of continuous evaluation, with a focus on optimising GLP quality in non-clinical studies. This approach aims to streamline processes, enhance reliability, and proactively address potential risks, thereby paving the way for a more robust and forward-looking framework in GLP studies. The aim of proactive risk assessment is to enhance the quality of GLP studies by ensuring reliability and addressing challenges that arise in the dynamic landscape of regulatory scenarios.

eConsent – A Quality-Driven Perspective

The informed consent process is fundamental in clinical trial where both the participant and investigator jointly decide on the participant’s involvement in the trial. Compliance and correct execution of this process is strongly regulated with the safety of the participant at the core. As we move forward into the digital age, eConsent is becoming more and more popular. eConsent does not change the traditional consent process. The same steps still applies and they include confirming interest, providing information, discussing, signing, and receiving a signed copy. There are also various eConsent models – there is no one-size-fits-all – but what they all have in common is the use of one or more digital features to support any of the consent process steps. The use of digital features to support the consent process can have an impact on the quality of the consent data (e.g. errors or missing data), data compliance and overall data integrity. It can also increase overall transparency in the consent process and secondary use of clinical trial data. This presentation will focus on quality aspects related to eConsent, the impact of different eConsent platforms and operational elements, as well as related GCP and other regulatory requirements.

Can/Should the Average GCP Auditor (Be Able to) Conduct IT Audits?

With the proliference of technology used in clinical trials, new guidance on computer systems and electronic data in clinical trials, and a new chapter on data governance coming in the ICH E6 R3 revision... what level of IT / CSV expertise does the 'average' GCP auditor need to have? How IT-literate do we have to be audit data integrity and GCP compliance?

Documenting the Machine Learning Life Cycle (MLLC)

The presentation shall examine the Machine Learning Life Cycle, its phases, and their individual importance in ensuring the quality and compliance of an AI system. This will include proposed deliverables for each phase and evidence to be generated to properly document actions and activities in support of system validation.

Unveiling the Future: Cutting edge technologies that are revolutionising pharmaceutical supply chains

Pharmaceutical companies must adopt technologies such as AI/ML, IoT, and Blockchain to stay competitive, while adapting to evolving regulations and geopolitical shifts. Quality management and supply chain operations must be agile, fostering innovation while prioritising risk mitigation and exploring the potential of said emerging technologies.

Risks and Issues - two sides of the same coin but still a field of challenge and confusion?

There is a fine line between risks (i.e., the problems that have not happened yet) and issues (i.e., the problems that have already happened) - that fine line being just a moment in time (“now”), and still a huge gap between them with regards to terminology and management.With already existing requirements of ICH E6(R2), and even more with the emerging requirements of ICH E6(R3), the importance of proper holistic compliance management (including risk management connected to the issue management) is getting more and more prominent.

Empowering the Quality Culture Roots For Better: What The Changing Regulations Want To Tell Us

The new version of Good Clinical Practice (ICH-E6 R3) and the Quality Risk Management Guideline (ICH-Q9 R1) push to adopt a "tailored" approach to study-specific activities. Therefore, QA professionals should empower the concept of Quality Culture among clinical research personnel to ensure that the regulatory standards are maintained over time and train colleagues to avoid unnecessary actions by maintaining high-quality standards.

Back to basics to secure the Future of Quality

Discussion regarding correct management of deviations.

GLP and GCP Lab Q&A, with the GLP Committee

Q&A session with the GLP committee providing insight into common questions.

Validating Statistical Software for GxP: A Computer Software Assurance Approach

More detail to follow.

IT Committee - Quality conversation roundup and this year's topics

As IT Committee we've started 2024 with two quality conversation sessions, one about CSV/CSA levering supplier partnership, and one about digital preservation. We want to take the virtual stage to round up those topics and also look ahead at our upcoming calendar. Engaging with the audience to have a conversation on possible topics of interest, questions and other ideas!

If you always do what you've always done, you'll always get what you've always got

When we experience quality issues in our organisation, traditionally we have the tendency to look at what should be changed to our processes and systems. Procedural changes, (re-)training or additional quality checks can all be necessary, but may have the opposite effect when we do not focus on the people side of quality management. In this presentation we are going to look at what an organisational quality culture means, what desired mindset, attitudes and behaviours a quality culture entails, and how we can possibly create a quality culture which can pave the way for continuous improvement.

Quality Undermined: Confronting the Menace of Microaggressions

Quality is not just a product of technical expertise; it is a result of the harmonious collaboration of individuals who feel valued, heard, and respected. In this short presentation, we will look at quality through a holistic lens and explore the subtle behavioural barriers that impede our journey towards excellence. As companies strive for diversity and inclusivity, delving into the impact of microaggressions on quality becomes imperative. Beyond a mere interpersonal challenge, these behaviours, when unaddressed, not only alienate and demoralise dedicated quality team members but also fosters a culture that obstructs the establishment of sustainable processes and systems essential for ensuring top-notch quality and sustained customer satisfaction. Join our brief, insightful session to gain insights on identifying and addressing such behaviours collaboratively and constructively, without resorting to shaming tactics. Elevate your understanding and commitment to a quality-driven culture. Learning Objectives: 1. Recognise when microaggression is being used to undermine a genuine quality concern and increase your confidence in responding assertively. 2. Build trusted relationships using open communication that fosters a respectful and collaborative environment. 3. Understand how to improve cross-cultural communication with others who perhaps have different analytical process and communication styles. 4. Feel empowered to call out microaggression and support those who have faced such behaviours that can affect their confidence and collaborative efforts. 5. Understand what an inclusive culture where diverse perspectives are valued, respected and innovation looks like.

Mastering Continuous Improvement: A Comprehensive Guide to Handling CAPAs Effectively

This will essentially answer the question - 'How to address CAPAs'. The talk will cover the basics of the CAPA process applicable across all GxPs and discuss the best practices to properly and effectively address CAPAs. The talk will draw on our industry experience. We will include hypothetical scenarios where a CAPA is addressed properly and one where a CAPA is not addressed properly.

Are you a Critical Thinker? Application for clinical trials.

Critical Thinking skills are necessary if working in a Good Practices (GxP) environment. But is not just GxP environments which require critical thinking skills. Critical thinking skills are essential in a world where disinformation and misinformation are rampant.

Diversity panel

In this roundtable discussion, we will explore the pivotal role of Diversity, Equity and Inclusion (DEI) as our industry grows globally and the workforce becomes more diverse. As Quality and Clinical professionals, we play a crucial part in shaping the industry we work in; so we will be uncovering how to best showcase representation in all walks of life.. Together, we'll discuss how embracing DEI enriches our profession in the global age.

Panellists include: Heather Wells, Quality Systems Director, Piran Sucindran, Head of Quality at Invicro and Mandy Budwal-Jagait, Head of GCP at MHRA and Nicholas Connor - the panel will be chaired by Steve Fuller, race in STEM. 

Use of AI in regulatory intelligence

Monitoring the complex and ever-changing regulations in the pharmaceutical industry poses a significant challenge. The manual process of monitoring and updating compliance documentation is not only resource-intensive but also vulnerable to human error, raising the risk of missing crucial regulatory updates. Our IMPALA Work Product Team (WPT) has developed an AI-driven approach to simplify and optimize this process. By leveraging artificial intelligence, our system can autonomously analyze new regulatory changes and systematically compare them against internal documents. This method ensures that discrepancies or missing information are quickly identified and addressed, thereby maintaining compliance. During our presentation, we will discuss the technical specifications of our system, including input and output formats, the AI modeling techniques used, the necessary infrastructure, and other operational details. This innovative approach aims to significantly improve efficiency and reduce the overhead associated with regulatory compliance in the pharmaceutical quality assurance space.

IMPALA update and details of the recently released Clinical Trial Anomaly Spotter (CTAS) open source package

More details to follow.