9:20 am Chair’s Opening Remarks

Operational Considerations for Compliance Groups

9:30 am Implementing European Data Integrity Laws in the Cloud

  • Manil Asija Global Quality Systems, Digital Technologies, Boston Scientific

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

10:00 am Ensuring E-Records Integrity of Cloud Services

Synopsis

  •  Defining NIST 800-57 in regards to data integrity
  • Identifying data integrity controls to be considered
  •  Integrating e-records into cloud services

10:30 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

10:45 am Facilitated by the Conference Chair – Efficiently Archiving Data in Cloud Hosted Systems

Synopsis

This interactive session will give you the opportunity to dive into the conversation
with your fellow colleagues to discuss, debate and get inspiration on how to
approach:

• Identifying data required for storage
• Understanding procedures for moving data into storage
• Ensuring that stored data is readily accessible to team members

11:15 am
Morning Coffee Break & Structured Networking Session

Exploring Methods for Compliant Systems Validation

11:45 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

12:15 pm 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

12:45 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

1:15 pm
Lunch Break & Networking

2:15 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

2:45 pm Panel Discussion: Finding the Least Burdensome Approach to Satisfy FDA Requirements

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

Synopsis

• Defining good documentation processes to prepare for audits
• Creating appropriate levels of testing
• Simplifying common documentation methodologies

Assuring Data Security in the Cloud

3:30 pm
Afternoon Coffee Break & Final Networking Opportunity

4:00 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

4:45 pm Guaranteeing Data is Encrypted, Secure & Has Low Risk of Being Manipulated

Synopsis

• Ensuring data is not deleted or changed
• Understand where data will be backed up if there is a breach
• Explaining the real time intrusion traffic encountered daily

5:15 pm Creating Mitigations for the Backup and Recovery of Data

  • Sanjeev Kumar Sr. Director - Data Integrity and Technology, Vertex Pharmaceuticals

Synopsis

  • Creating a backup and recovery plan
  • Understanding first steps when data is lost
  • Utilizing different recovery strategies

5:45 pm Chair’s Closing remarks