Registration, Networking, Exhibition Hall Open and Continental Breakfast

Chair’s Welcome Back Note & Opening Remarks

Natasha Demberg, BSc, MSc, Quality & Compliance, Demberg Pharma Solutions

A 2026 FDA warning letter specifically criticized a manufacturer for lacking PPQ studies, inadequate on going process monitoring, and failure to validate cleaning of shared equipment. Another cited incomplete validation data, missing process parameters, and changing specifications during validation rather than investigating the underlying process failure.

Preparing Your Manufacturing Validation Program for an FDA Inspection

• Building the inspection-ready validation story
• Validation Master Plan and validation inventory
• Connecting CQAsÒCPPs Òcontrols ÒPPQ Ò CPV
• Document traceability and rapid document retrieval
• Preparing SMEs for investigator questions
• Mock inspections and validation “war room”
• How to explain deviations and historical validation gaps
• Identifying and remediating gaps before the inspector identifies them
• Responding effectively to FDA Form 483 observations

FDA notes that investigators typically examine production processes and records during inspections, making it especially important to demonstrate a coherent, documented state of control.

Presented by: Dr. David W. Vincent, B.Sc., MPH, PhD, Chief Scientific Officer (CSO), VTI Life Science

Raw Material Transportation in the GMP Environment: A Risk-Based Framework for Product Quality, Compliance, and Supply Chain Resilience

Presented by: Viorel Buculei, M.Sc., MBA, Director Quality Control, Jubilant Radiopharma

Registration, Networking, Exhibition Hall Open and Continental Breakfast

Cost of Quality related to 2nd party audits and common GMP audit findings

This session explores effective approaches to optimizing supplier qualification processes while reducing organizational risk and lowering the overall cost of quality. Participants will gain insight into the true costs associated with supplier audits and learn practical, proven strategies for improving audit efficiency without compromising regulatory compliance, product quality, or patient safety. The discussion high lights methods for balancing cost reduction with robust supplier oversight, enabling organizations to strengthen supply chain performance and maintain high standards of quality assurance.

Summary:

Learn how to optimize your supplier qualification process while significantly lowering both risk and the total cost of quality. This session examines the true cost of conducting supplier audits and presents practical, proven strategies to reduce it without compromising compliance or patient safety.

Learning Objectives

1. Implement practical strategies to reduce the cost of supplier audits without compromising regulatory requirements or quality standards.
2. Apply risk-based approaches to supplier qualification and auditing through third party certifications to improve effectiveness while optimizing resource utilization.
3. Develop a balanced supplier oversight framework that supports compliance, minimizes risk, and drives reducing the cost of quality across the supply chain.

Presented by: Jon Gawlak, Technical Manager / Senior Auditor, SGS Business Assurance, Pharmaceutical, Cosmetics, and Personal Care (PCPC), SGS

Digitized Does Not Mean Integrated

Why the Future of Commissioning & Qualification (C&Q) Depends More on Project Delivery Excellence Than Validation Technology

The life sciences industry has invested heavily in paperless validation, digital turnover platforms, e-protocols, and Validation 4.0 initiatives with the expectation that these technologies would significantly improve project performance. Yet many capital projects continue to experience the same schedule delays, readiness challenges, and inefficient handoffs that existed long before these tools were introduced.

This presentation explores the distinction between a digitized C&Q process and a truly integrated project delivery model. Attendees will learn why technology alone rarely resolves the underlying constraints that drive project performance and how leading organizations are shifting their focus from validation deliverables to system readiness, risk reduction, and cross-functional integration.

Key discussion topics include:

• The difference between digitized execution and integrated execution
• Why many “Integrated C&Q” programs remain functionally siloed
• Common project delivery constraints that technology alone cannot solve
• The critical role of engineering, construction, commissioning, quality, and operations alignment
• How project delivery disciplines such as integrated planning, readiness management, risk management, and turnover strategy influence C&Q success
• A vision for the future where digital tools enable integration rather than substitute for it

Attendees will leave with a practical framework for evaluating whether their organization is merely digitizing existing processes or truly transforming the way projects are delivered.

Presented by: Aaron Roth, B.S., Director, Project Services, MMR Consulting

Morning Panel Q&A / Discussion

Moderator: Jon Gawlak, Technical Manager / Senior Auditor, SGS Business Assurance, Pharmaceutical, Cosmetics, and Personal Care (PCPC), SGS

Panelists:
Dr. David W. Vincent, B.Sc., MPH, PhD, Chief Scientific Officer (CSO), VTI Life Science
Viorel Buculei, M.Sc., MBA, Director Quality Control, Jubilant Radiopharma
Aaron Roth, B.S., Director, Project Services, MMR Consulting

Networking Lunch & Exhibition Viewing

Digital Transformation and AI Applications in Quality Management

The rapid evolution of digital technologies and artificial intelligence (AI) is creating new opportunities to transform Quality Management Systems (QMS) from largely transactional and document-centric processes into more connected, data-driven, and proactive quality ecosystems. However, implementation within regulated environments requires organizations to balance innovation with established expectations for validation, data integrity, traceability, risk management, human oversight, and lifecycle governance.

his presentation will share a practical digital transformation journey focused on modernizing quality work flows and progressively introducing AI-enabled capabilities within the current boundaries of regulated system validation. Rather than approaching AI as a replacement for established quality processes or human decision-making, the strategy focuses on identifying fit-for-purpose applications where digitalization, automation, advanced analytics, and AI can augment quality professionals, reduce non-value-added activities, improve access to information, and strengthen quality governance.

Examples will illustrate the progression from foundational workflow digitalization and data integration to more advanced use cases such as intelligent information retrieval, AI-assisted review and summarization of quality records, quality-event classification and triage, identification of recurring themes and emerging signals, support for investigation and root-cause analysis, and generation of actionable insights from previously fragmented quality data. The presentation will also discuss use cases currently in the development pipeline and the criteria used to determine which applications can be responsibly deployed within GxP-regulated processes.

Current regulatory perspectives will be considered alongside practical approaches for risk-based as surance, clearly defined context of use, human-in-the-loop controls, performance monitoring, change management, and governance.

The presentation will conclude with a scalable framework for progressing from digital quality to intelligent quality—demonstrating how organizations can establish the technology, data, governance, and operating-model foundations necessary to accelerate continuous improvement while maintaining appropriate quality oversight, regulatory compliance, and patient-focused decision making.

Presented by: Jaivik Patel, Site Quality Head, Whitby Site, ThermoFisher Scientific

Pharma Quality Expectations for AI/ML Solution Providers; AI Validation Framework Approach

The pharmaceutical industry must navigate a regulatory paradox: compliance with the EU AI Act is insufficient for GxP standards. While the Act addresses broad ethical and societal risks, GxP mandates focus strictly on patient safety, product quality, and data integrity. Consequently, solutions classified as low risk under the Act often constitute high risk in clinical or manufacturing contexts where incorrect out puts impact health outcomes.

Providers are mandated to adopt ISO/IEC 42001 or any equivalent industry standard as their AI Management System foundation. This organizational framework must align with EMA Annex 11, as AI solutions are regulated as computerized systems to enforce robust data integrity and quality management.

The industry shift from reactive assistants to proactive agents necessitates a more rigorous validation pathway. Unlike user-led tools, proactive agents execute autonomous, multi-step tasks through independent decision-making. Increased agent complexity across dimensions of perception, internal planning, and adaptability triggers these heightened GxP requirements compared to traditional machine learning models. Assuring agent reliability requires specialized Agent Controls providing verifiable engineering constraints. These controls map to ALCOA++ principles, necessitating reasoning logs that are human-readable and queryable to ensure legibility, alongside immutable logs for originality. Validation must follow a risk-commensurate strategy: Unit Testing for isolated components; System Acceptance Testing for tool connections, minimal Agent Controls, and strict red-teaming; and User Acceptance Testing for end-to-end fitness-for-use. This structured hardening is the only path to safe adoption within the GxP ecosystem.

Presented by: Kathy Zielinski, MS, AI/ML Compliance Team Lead, Hoffmann-La Roche Ltd

Mid-Afternoon Refreshment Break & Exhibition viewing

Beyond AI: The Human Decisions That Still Matter in Pharma
Expertise, Accountability and Trust in the Age of AI

Adam Hazourli, Founder of eBiotech.ai and President of Abrévia Inc.

AI in GMP, Made Concrete
Shifting the Effort Upstream — A Practical Playbook for CSV and Beyond

Most AI conversations in GMP stay at 30,000 feet. This session walks through one real Computer System Validation project instead: real prompts, real generated documents, real risk assessments, and real test scripts — all on screen, all traceable.

We start with how CSV effort is spent today, then show what changes when you invest in one detailed functional specification and let risk assessment, test strategy, and test scripts cascade from it — faster, and with consistent structure and quality. Before the worked example, we stop at the first question a regulated organization should ask: where does a batch record, an SOP, or a quality event go when it is pasted into an AI tool, and how do you evaluate any such tool against that question.

We follow one requirement from prompt to executed test script, look at how SME, author, and QA roles shift — and which independence rule does not. We close with something you can try Monday morning, not only on functional Specifications but on a CAPA, a deviation, or an investigation.

Kia Kahhali, President, APS Compliance Consultants Inc

Afternoon Panel Q&A

Where Do We Go From Here?

The Future of GMP Quality in the Age of AI

Participating speakers to be confirmed, subject to time availability.

Conclusion of Conference