8:50 am Chair’s Opening Remarks
Operational Considerations for Compliance Groups
9:00 am Implementing European Data Integrity Laws in the Cloud
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
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
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
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
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
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