8:30 am Registration & Welcome Coffee
9:20 am Chair’s Opening Remarks
Harnessing Automated Processes to Simplify Compliance
9:30 am GxP Process Automation & Continuous Cloud Compliance
Synopsis
- Managing GxP and Non-GxP workflows on the ServiceNow Platform
- Solving for 21 CFR Part 11 eSignatures and audit trails
- Automating and scaling your business processes while maintaining compliance
- Out-of-the-box solutions for Regulated IT Workflows, GMP Manufacturing Workflows, Adverse Event Workflows and more
Laying Out the Path for Aligning to the FDA’s CSA Draft Guidance
10:00 am Effectively Introducing a Global Implementation of a SaaS Based Solution Using a CSA Approach
Synopsis
- How to perform a major technology transformation while utilizing an unproven CSA Approach in a risk-adverse company
- Overcoming obstacles with technology differences, user adoption, and management uncertainty
- Operationalization of CSA approach and maintaining compliance long-term
10:30 am Morning Break and Speed Networking
Synopsis
This session is a great opportunity to introduce yourself to IT experts across leading biotech and pharma organisations. This session is the ideal place to get face-to-face time with many of the brightest minds capturing the main challenges in cloud computing to establish meaningful business relationships.
11:30 am Panel Discussion: How Can You Leverage CSA to Ensure Compliance and Reduce Documentation?
Synopsis
- Overcoming the challenges CSA guidelines pose by frontloading effort into more extensive risk assessments
- What work is required to properly implement a CSA approach, including cloud IQ/OQ certificates from cloud service providers?
- How do you leverage vendor testing in an organization’s authoring of a PQ?
Leveraging Strategies for Continuous Compliance in a GxP Regulated Environment
12:15 pm Leveraging GxP Cloud System Change Control Tactics to Remain Compliant
Synopsis
- Understanding the types of changes for the system
- Discovering the capabilities of the vendor in controlling and managing your cloud system
- Strategies for aligning version update releases with your change management program
12:45 pm Lightweight GxP Content Management Systems for Emerging Life Sciences
Synopsis
- Planning for the future, strategies for getting organized
- Key controls your need: structure, access, policies and freedom
- Advanced: workflows & guardrails
1:15 pm Lunch Break & Networking
2:15 pm Trust, Assurance & Compliance in the Cloud for the Life Sciences Industry
Synopsis
- Leverage the Cloud Controls Matrix (CCM) to align your IT strategy and improve the security and compliance of your organization
- Reference the publicly accessible STAR registry to find providers that align with your security, data privacy and compliance needs
- Bolster your team’s internal cloud security knowledge by pursuing the Certificate of Cloud Security Knowledge or Certificate of Cloud Auditing Knowledge training programs
Effective Vendor Management Approaches to Reduce Excess Workload & Cost
2:45 pm Deploying the Agile & Compliant Use of Cloud Managed Infrastructures
Synopsis
- Deploying quickly and efficiently infrastructures and system in a fast-growing company: is cloud the only solution?
- Demonstrating compliance to regulators (real use case)
- Potential risks/misunderstandings compared to traditional model
3:15 pm Panel Discussion: Leveraging Vendors to Simplify Validation
Synopsis
- CSA promotes leveraging vendor activities; it starts with selecting the right vendor
- Customer vs vendor responsibilities for achieving and maintaining compliance
- Considerations for release management to ensure continuous compliance
- Guidance to improve your cloud compliance and automation maturity