8:50 am Chair’s Opening Remarks

  • Radha Ramesh Principal IT Specialist, Compliance, Ultragenyx

Operational Considerations for Compliance Groups

9:00 am Implementing European Data Integrity Laws in the Cloud

  • Manil Asija Director of Design Quality Assurance, Butterfly Networks

Synopsis

• Applying General Data Protection Regulations (GDPR) in the EU
• Understanding the how compliance is achieved with robust data
• Developing software validation approaches to remain compliant

9:30 am Accelerating the Adoption of AI and Industry 4.0 Technologies in Highly Regulated Environments

  • Andy Alasso Senior Vice President of Product Management, Aizon

Synopsis

-Outlining how industry 4.0 technologies can be used in conjunction to help integrate and harmonize your data
– Compliantly conducting data acquisition
– Safely applying AI/ML in a GxP environment to ensure data integrity, encryption, certification, and other key aspects of data management

10:00 am
Morning Coffee Break

10:30 am Utilizing Cloud Computing Platforms with FDA and European Compliance

Synopsis

  • Outlining compliance and quality concerns with cloud computing platforms integrated into medical devices
  • Explaining practical examples of approaches that can be used to mitigate challenges
  • Approaching cloud software that updates automatically

Exploring Methods for Compliant Systems Validation

11:00 am GxP Data Lake- The Dynamic Data and its Governance

  • Patrick Diette Manager, Validation Quality Systems & Compliance, Alkermes

11:30 am Case Study: A Risk-based Approach to Validating GxP Cloud Systems in Accordance with FDA Regulations

Synopsis

• Outlining different validation methods
• Implementing a practical risk-based approach
• Understanding the risk framework

12:00 pm
Lunch Break & Networking

1:00 pm Case Study: Utilizing Automation Techniques to Reduce Workload

  • Matt Neal Senior Director, Regulatory Affairs Operations, Atara Biotherapeutics

Synopsis

• Developing strategies for continuous validation
• Creating approaches for automating qualification
• Using automation while also maintaining compliance

1:30 pm Case Study: Executing FDA Compliant and Effective Validation

  • Radha Ramesh Principal IT Specialist, Compliance, Ultragenyx

Synopsis

• Understanding what needs to be leveraged for effective validation
• Validate, Commission or Qualify – determine approach based on task
• Leveraging the level of documentation required

2:00 pm
Afternoon Coffee Break & Final Networking Opportunity

Assuring Data Security in the Cloud

2:30 pm Panel Discussion Creating Mitigations for the Backup & Recovery of Data

Synopsis

• Designing a backup and recovery plan
• Understanding immediate steps when cloud services are compromised
• Leveraging different recovery strategies

3:15 pm Round Table Discussions

  • Vishal Goyal Director, IT Business Partnering R&D, Clinical, CMC, Manufacturing, TCR2 Therapeutics
  • Mikhael Danan Director R&D, Clinical IT, Affinivax

Synopsis

This interactive session gives you the opportunity to be part of the discussion –
to share ideas and learn from your peers. Choose the table most relevant to you
and get ready to be part of this conversation!

  • Perfecting Internal Audits
  • Using Tools from Cloud
    Providers
  • Understanding International
    Regulations

4:00 pm Chair’s Closing remarks

  • Radha Ramesh Principal IT Specialist, Compliance, Ultragenyx