DTG Insights Hub — Confidential

EFA Digi — DTG Advisory Session

AstraZeneca API Södertälje · Thoughts on Structure & Support
Draft v0.2 · April 2026

Proposed Day Agenda

09:30 – 16:00 · Site API, Södertälje · DTG: Steven Kenny, Scott Thomson, Sean O'Connor, Tony Depledge, CSV Lead TBC
Welcome
Context
DTG Input
Workflow
Governance
Risks
Asks of DTG
Summary
Close
Buffer
09:30
15 min
Welcome
All
Welcome & Scene-Setting
Welcome from AZ site leadership and DTG. Introductions: DTG team (Steven Kenny MD, Scott Thomson Ops Director, Sean O'Connor, Tony Depledge, CSV lead TBC) and AZ counterparts (Hanna Samuelsson, others TBC).
09:45
15 min
Context
Steven
Aims & Approach for Today
Overview of what we all hope to achieve from the day. How the session is structured and why. Builds and corrections from AZ as needed. What good looks like by the end of the day — alignment on the approach for project conclusion, transition to 'In Use' and hypercare.
10:00
45 min
Context
AZ - Hanna?
Where Are We? — Current Status and AZ Approach to C&Q
AZ summary of the current project position. Status of ongoing parameterisation and dummy-run activity across process areas. AZ to play back on responses to recent queries via Tony - and an overview of current approach to CQV phase.
10:45
45 min
DTG Input
DTG
DTG Recommendations: Organisation
DTG's recommended organisation for the CQV execution post dummy runs. Proposed team structure, role clarity, and accountability mapping. Key interfaces between areas and functional support functions. Lessons from earlier phases and how they inform the recommended structure. Open discussion on capability/capacity concerns if needed.
11:30
15 min
Workflow
Tony (Dial in) and Sean
DTG Recommendations: Ways of Working — Physical Layer
Recommended approach to Physical Layer commissioning and qualification (CM & EM layers). Test documentation structure and expectations. Parameterisation sign-off gates: what constitutes readiness to proceed. Role of area teams during physical layer execution.
11:45
15 min
Workflow
Tony (Dial in) and Sean
DTG Recommendations: Ways of Working — PH & OP Layer
Recommended approach to PH & OP commissioning and qualification. Sequence of activities and dependencies on Physical Layer completion. Documentation and acceptance criteria expectations. Open questions and clarifications.
12:00
15 min
Workflow
Tony (Dial in) and Sean
DTG Recommendations: Ways of Working — Unit Procedures
Recommended approach to Unit Procedures OQ execution. Sequencing, test documentation, and dummy-run readiness gates. Role of area teams and CSV support during execution.
12:15
15 min
Workflow
Tony (Dial in) and Sean
DTG Recommendations: Ways of Working — Recipe Procedure
Recommended approach to Recipe Procedure OQ/PQ execution. Acceptance criteria, report data, and dynamic alarm parameterisation. Handoff sequencing between procedure layers.
12:30
15 min
Workflow
Tony (Dial in) and Sean
DTG Recommendations: Ways of Working — OQ Unit Operations & OQ/PQ Recipe
Recommended approach to OQ Unit Operations and OQ/PQ Recipe execution. Outstanding parameterisation and dummy-run requirements before proceeding. Critical path dependencies and final readiness criteria.
12:4545m
Lunch
13:3060m
Dummy Runs Meeting
13:30
45 min
Context
AZ and DTG
Reflections & Open Discussion — Ways of Working
Open discussion and reflections on the Ways of Working presentations from the morning. Key questions, challenges, and clarifications from the group.
14:15
25 min
Risks
Scott
Risks & Watch Points
Key risks and watch points for the execution phase. Ensuring ongoing focus on risk management and safety considerations.
14:40
15 min
Summary
All
Asks of DTG & Wrap-Up
Open session for the AZ team to articulate what they need from DTG in the coming weeks. Structured recap of the day's key decisions, agreed recommendations, and action items. Owner and deadline assigned to each action.
15:00
60 min
Context
EFA Digi Steering
EFA Digi Steering meeting.
16:00
60 min
Buffer
Over-run / Buffer
Unstructured time held in reserve for over-run from earlier sessions or any additional topics raised by the team during the day.