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

Synopsis

  • 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 Simplified Data Governance: A Paradigm Shift to Risk-based and Vigilant Monitoring

  • Tracy Hibbs Principal Consulting Product Marketing Manager, Waters Corp.

Synopsis

  • Navigating data governance expectations in today’s regulated landscape and the criticality of monitoring
  • Evolving risk and risk assessment with transformed solutions
  • Modernizing vigilant monitoring to significantly mitigate risks and enhance decision-making

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

Synopsis

  • 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 Building Quality into GxP AI – How quality systems can responsibly control AI

Synopsis

  • GxP use cases where AI is emerging
  • Quality System practices for managing AI in GxP
  • The role of vendors, IT and Quality in controlling GxP AI
  • Investments needed to scale AI capabilities into future GxP use cases

11:40 am Navigating Vendor Selection & Onboarding: Strategically Selecting Vendors to Match Your Objectives

Synopsis

  • 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 

12:10 pm The Evolution of Vendor Selection: Impactful Strategies for Lifecycle Success

  • Monica Hunter Global Director Quality Systems Management, Alkermes

Synopsis

  • 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

12:40 pm Auditing Cloud Vendors for Quality Assurance: Ensuring Compliance & Vendor Reliability

Synopsis

  • 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

1:10 pm Lunch Break & Networking

Managing Multiple Cloud Providers to Optimise Efficiency

2:10 pm Navigating Cloud Provider Update Frequency Challenges

Synopsis

  • 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

2:40 pm Roundtable: Establishing a Framework for Continuous Compliance Across Multiple Cloud Providers

Synopsis

  • 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 

3:10 pm Ensuring Continuous Evidence: Navigating GxP Compliance in Cloud Services

Synopsis

  • 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 

3:30 pm Afternoon Break & Networking

3:40 pm Chairs Closing Remarks

3:50 pm End of Conference