The integrity of data generated, processed, and stored within GxP-regulated environments sits at the heart of pharmaceutical compliance. As regulatory frameworks continue to evolve — and as digital transformation accelerates across the industry — organisations face mounting pressure to ensure that every data point created throughout the product lifecycle is attributable, legible, contemporaneous, original, and accurate (ALCOA+).

This three-session webinar, From Guidance to Practice, is designed to bridge the gap between regulatory text and real-world implementation. Drawing on the requirements of EU Annex 11 (Computerised Systems), the newly drafted EU Annex 22 (Management of Data and Records), and the FDA's evolving guidance on data integrity and computer software assurance, the programme offers practitioners a structured, expert-led pathway through the regulatory landscape.

Each session has been architected to deliver standalone value while collectively forming a complete learning journey — from foundational regulatory interpretation, through practical system validation and audit readiness, to the emerging governance challenges posed by Artificial Intelligence and Machine Learning in regulated settings.

The webinar is led by seasoned practitioners with hands-on inspection and implementation experience, ensuring that content goes beyond theory and equips attendees with actionable tools, frameworks, and insights they can apply directly within their organisations.

Cross-Series Outcomes:

• Build a comprehensive regulatory intelligence map spanning EU Annex 11, Annex 22 Draft, and FDA data integrity requirements
• Access practical templates, checklists, and decision frameworks applicable immediately within your organisation
• Develop a risk-based, inspection-ready data integrity programme adaptable across manufactur-ing, quality, and clinical environments

Who Should Attend:

This webinar has been developed for professionals working in or intersecting with GxP-regulated environments who are responsible for compliance, system validation, quality oversight, or technology governance. Whether your focus is operational, technical, or strategic, each session provides directly applicable value.

• Quality Assurance & Quality Systems Managers

Understand what has changed across EU Annex 11, Annex 22 Draft, and FDA guidance, and translate those changes into ALCOA+-compliant quality systems and audit-ready controls.

• Regulatory Affairs Professionals

Gain clarity on how regulators are currently interpreting data integrity requirements globally and what the evolving framework means for submissions and inspection strategy.

• IT, CSV & Computer System Validation Specialists

Apply data integrity by design principles to computerised systems, configure compliant audit trails, and assess the qualification requirements for AI-powered monitoring tools.

• Compliance Officers & GxP Auditors

Map regulatory expectations across EU and FDA frameworks, identify common inspection deficiencies, and evaluate AI-driven anomaly detection as part of a broader audit programme.

• Manufacturing & Operations Leaders

Understand the operational impact of ALCOA+ requirements across hybrid environments — where paper and electronic records intersect — and how AI monitoring can strengthen data integrity on the shop floor.

• Data Scientists & Digital Transformation Teams

Navigate the GxP regulatory landscape when deploying AI and ML tools, including qualification expectations, algorithm transparency, model drift, and output traceability.

• Senior Leaders & Heads of Quality / Compliance

Build strategic oversight across the full data integrity landscape — from regulatory framework changes through to technology-enabled monitoring — to make informed decisions on compliance investment and capability.

This webinar is equally valuable for professionals at pharmaceutical manufacturers, CROs, CDMOs, medical device companies, and life sciences consultancies operating under GxP regulatory frameworks.