Day Two Agenda

Thursday, September 12, 2024

8:00 am Coffee & Networking

8:55 am Chairs Opening Remarks

Navigating Data & Security Challenges in the Cloud: Stategies & Best Practicies to Safeguard Sensistive Data

9:00 am Managing Incident Responses & Data Breaches: Mitigating Risks to Integrity & Confidentiality


  • Where does accountability lie in the event of a data breach?
  • Develop effective response plans and strategies to minimize impact
  • Proactive methods to enhance preparedness 

9:30 am Securing On-Premise to Cloud Connections: Best Practices & Strategies


  • Discussing how to securely connect the physical lab environment to cloud-based data analytics and system monitoring applications
  • Identifying common security and configuration challenges when establishing connections between on-premise infrastructure and cloud platform
  • Showcasing real-world scenarios and case studies where organizations have successfully connected edge device software in the lab to cloud-based solutions

10:00 am Securing Critical Data: Best Practices in Vendor Security & Policy Compliance


  • Effective risk assessment methodologies to determine value of information/data
  • Key security considerations for third-party evaluation/assessment
  • Strategies for mitigating risks associated with sensitive data handling and maintaining compliance with regulatory requirements

10:30 am Morning Break & Networking

Optimising Vendor Selection & Management to Enhance Partnerships for Streamlined Operations

11:30 am Navigating Vendor Selection & Onboarding: Strategically Selecting Vendors to Match Your Objectives

  • Mary Llewellyn Director, GMP Quality Assurance, Prelude Therapeutics​


  • Aligning vendor criteria with organizational goals
  • Examining how to conduct thorough audits to streamline the vendor selection process
  • Optimizing resources and alignment with cloud vendors 

12:00 pm The Evolution of Vendor Selection: Impactful Strategies for Lifecycle Success

  • Monica Hunter Global Director Quality Systems Management, Alkermes


  • Developing a comprehensive framework for managing vendors throughout project lifecycles
  • Ensuring vendor alignment with evolving project requirements
  • Strategies for fostering successful vendor relationships beyond the initial selection phase

12:30 pm Auditing Cloud Vendors for Quality Assurance: Ensuring Compliance & Vendor Reliability

  • Nityanand Choubey Director, Global Development Quality Assurance, Regeneron Pharmaceuticals Inc


  • Understanding the critical importance of data integrity in cloud environments and how to assess vendor controls
  • Exploring key security considerations for protecting sensitive data stored and managed by cloud vendors
  • Examining the vendor’s processes for onboarding pharmaceutical customers

1:00 pm Lunch Break & Networking

2:00 pm SLA Best Practices & Vendor Documentation Strategies


  • Exploring best practices for defining and implementing clear Service Level Agreements (SLAs) to delineate responsibilities and manage risks between business owners and cloud providers
  • Discussing the importance of leveraging comprehensive vendor documentation
  • Insights on establishing governance frameworks that facilitate effective collaboration and accountability between cloud service users and vendors

Managing Multiple Cloud Providers to Optimise Efficiency

2:30 pm Navigating Cloud Provider Update Frequency Challenges

  • Steven sledz Senior Director of Information Technology, Tolmar
  • Wayne Oleski Information Technology Program Manager, Tolmar


  • Addressing the challenges posed by variation in update schedules from cloud providers
  • Implementing proactive approaches to stay abreast of update schedules and changes
  • Preparing contingency plans to mitigate unexpected issues from cloud service updates

3:00 pm Establishing a Framework for Continuous Compliance Across Multiple Cloud Providers


  • Exploring how automated models can be used to reduce the burden of manual validation
  • Developing strategies to integrate automated compliance into existing workflows
  • Challenges, best practices and lessons learnt 

3:30 pm Afternoon Break & Networking

4:00 pm Ensuring Continuous Evidence: Navigating GxP Compliance in Cloud Services


  • Real-time monitoring and documentation of cloud infrastructure and application changes for continuous GxP compliance
  • Automation-driven streamlining of evidence collection for continuous compliance
  • Technology strategies for navigating the shared responsibility model in cloud compliance 

4:30 pm Chairs Closing Remarks

4:40 pm End of Conference