Day One Agenda

Wednesday, September 11, 2024

8:00 am Coffee & Registration

8:55 am Chair’s Opening Remarks

Mastering Regulatory Compliance: Strategies for Guideline Adherence & Risk Management

9:00 am FDA: Fostering Digital Transformation & Product Quality

  • Francisco Vicenty Case For Quality Program Manager, US Food & Drug Administration (FDA)


  • Exploring the FDA’s perspective on leveraging digital technologies and cloud capabilities
  • Understanding the flexibility of regulatory requirements and adopting a risk-based approach to validation efforts
  • Discussing the FDA’s evolving perspective on technology integration

9:30 am Roundtable: Ensuring Successful Adoption of FDA Guidelines for Pharmaceutical Companies


  • Challenges and consideration in aligning FDA guidelines, geared towards medical devices, with pharmaceutical industry standards
  • Strategies for adaptation to meet the specific needs and complexities of the pharmaceutical sector
  • Examples that illustrate successful integration from pharmaceutical companies

10:00 am Panel Discussion: Strategic Risk Management – Mapping the Terrain of Regulatory Challenges


  • Navigating different levels of risk assessment including system level and requirement level
  • What are the best practices for conducting risk assessment and implementing management strategies?
  • Hear a range of effective risk management strategies from pharma/biotech/equipment companies

10:30 am Morning Break & Structured Networking


Engage directly with industry peers and IT decision-makers in an environment designed for meaningful conversations and valuable professional connections. This structured format ensures purpose-driven interactions to maximize networking opportunities and gain actionable insights

11:30 am Implementing Regulatory Guidelines: Practical Approaches for Effective Application

  • Harry Wolfgang Leader, Technology Regulatory Compliance, Johnson & Johnson Services, Inc


  •  Strategies for translating regulatory guidelines into practical implementation plans
  • Case studies and examples of successful application of compliance guidelines
  • Discussing best practices for ensuring compliance with regulatory standards

Adapting to the Speed of Change: Harmonising Traditional Practices with Rapid Innovations

12:00 pm Bridging the Educational Gap in Technology Adaption

  • Munya Mafemba Associate Director, Regulatory Compliance R&D – Technology, Signant Health


  • Identifying the disparity between traditional QA practices and evolving technological landscapes
  • Discussing the challenges arising from the lack of familiarity with cloud technologies among QA professionals
  • Exploring effective strategies to enhance understanding and implementation of cloud technologies

12:30 pm Lunch Break & Networking

1:30 pm Life Science Vendor Risk Scoring: Making Better Vendor Partnership Decisions with Cloud Technology


  • Using agency enforcement data to assign relative risk scores to vendors in the global life sciences supply chain
  • Helping marketing license holders to ensure their supply chain is GxP-compliant
  • Discussing how intelligence solutions can systematically reduce compliance risk and ultimately improve product quality

2:00 pm Presentation By Validated Cloud

Optimising Cost Efficiencies: Strategic Decision Making for In-house & Outsourced Operations

2:15 pm Analysing The Financial Implications of Cloud Computing to Optimise Costs

  • Chris Clayton Director of Information Technology, INCOG BioPharma Services


  • Identifying and quantifying potential hidden costs associated with cloud services
  • Selecting license types based on user needs
  • Cost differences between support, training, and project services

2:45 pm Afternoon Break & Scientific Poster Session


After the formal presentations have finished, the learning and networking carries on. The Poster Session allows you to connect with your peers in a relaxed atmosphere and continue to forge new and existing relationships. During this session, scientific posters will be presented on the very latest advancements in GxP cloud compliance strategies and best practices. They will aim to inform and guide future efforts in navigating requirements and optimising compliance in a cloud environment.

3:45 pm Determining the Right Approach for Deploying Applications & Workload in the Cloud

  • Adam Moore Head of Global Cloud Solutions, Elekta AB


  • Exploring how standardized configuration and infrastructure as code techniques enable rapid deployment and scalability in cloud environments
  • Discussing the role of artificial intelligence (AI) in optimizing cloud operations and reducing deployment times
  • Addressing key considerations for maintaining robust security measures and regulatory compliance during cloud deployments

4:15 pm Chairs Closing Remarks

4:20 pm End of Day