*All Times Shown are in Eastern Daylight Time*
9:00 am Join our Virtual Coffee Chat Room to continue the conversation from Day 1
9:25 am Opening Remarks from the Chair
GxP Cloud Infrastructure’s Scalability, Reliability & Availability
9:30 am GxP Compliance in the New Virtual Model
Synopsis
• Cloud change control: what to expect from your cloud provider, and how much should you do
• Remote 21 CFR Part 11 compliant execution – working from home, CSV execution, GxP forms
• Case study: Easy GxP – creating simple compliant processes byadding accountability to data integrity and cybersecurity assessments, and audit questionnaires
10:00 am Continuous Compliance in Regulated Industries
Synopsis
• Streamline Efforts with Continuous Compliance
• Detect security vulnerabilities and report non-compliance in real-time
• Reduce audit cycle times and close the remediation loop
10:30 am An Auditor’s View: Quality & GxP Regulatory Compliance Considerations for Cloud
Synopsis
• Risk management, critical thinking, and assurance needs in CSV
• Required elements in quality contractual agreements
• Practical case study discussion in pitfalls and opportunities to enhance best practices
11:00 am Morning Virtual Speed Networking
Synopsis
Take part in this ice breaking session where our Hopin platform will pair you up with a fellow attendee to spark a 5mins chat – expand your network and reconnect with your industry partners in this new virtual world!
Implementing a 3600 Quality Management of GxP Cloud
11:30 am Cloud Validation & How to Adhere to Industry Standard’s Compliance
Synopsis
• Determining how to evidence that your system can produce consistent and reproducible results in compliance with GxP regulations
• Understanding how initial validation and ongoing re-validation are critical to success
12:00 pm Accelerate Product Development with a Unified, Validation-Ready Benchling Solution
Synopsis
• As life science companies advance their products through the R&D lifecycle, the focus gradually moves from hypothesis-driven research to more controlled, structured development that falls under the scope of regulatory compliance and validation.
• Often this drives companies to use disparate IT solutions, making it increasingly difficult for Research and Development teams to collaborate across phases.
• In this presentation, learn how New England Biolabs leverages Benchling’s unified, validation-ready solution to improve tech transfer, reduce validation time, generate meaningful insights, and enable faster assembly of data packages.
12:30 pm Lunch Break | 1-2-1 Meetings
Synopsis
Grab a bite whilst joining our virtual lunch chat room, or use this opportunity to visit our Partners’ Virtual Booths
1:30 pm Panel Discussion: How to Define Data Security, Integrity & Standards
Synopsis
• Risk identification specifically for Cloud providers (SaaS, PaaS, IaaS, ASP, BPO)
• Critical internal controls to protect data integrity, privacy, and availability
• How to be inspection-ready at all times
• Effective enterprise governance, risk, and compliance
• Uncovering what tools and best practices should be prioritized when moving to the cloud
• How GxP compliance, cyber security and QA teams can address top security concerns, challenges and vulnerabilities?
2:15 pm The Role of GxPs for Product Development for a Growing CRO
Synopsis
• Establishing an efficient quality control/quality assurance unit to satisfy GLP, GCP and GMP
• Exploring data retention and data archiving to ensure GLP compliance
2:45 pm Addressing the Increasing Risks of Cyber Security
Synopsis
• Defining your cyber-threats and considering the consequences
• Mitigating and managing risks
• Considering security during design, development and operational phases