*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

  • Octavian Boca Principal , Massachusetts Technology Innovation Corp.

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

  • Calvin Kim Senior Director, Head of Quality System Validation, Samsung Biologics

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

  • Anca Mihaescu Associate Director, IT Computer Systems Validation , Jazz Pharmaceuticals Inc

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 Addressing the Increasing Risks of Cyber Security

  • Michael Redmond Sr. Consultant & Sr. Auditor, Cyber/ Information, Security & Risk Management , Redmond Worldwide

Synopsis

• Defining your cyber-threats and considering the consequences
• Mitigating and managing risks
• Considering security during design, development and operational phases

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

1:15 pm Panel Discussion: How to Define Data Security, Integrity & Standards

  • Victor Huynh Executive Director, Information Security & Risk Management, AbbVie
  • Michael Redmond Sr. Consultant & Sr. Auditor, Cyber/ Information, Security & Risk Management , Redmond Worldwide
  • Rimesh Gor Associate Director, IT Business Relationship Management , Orchard Therapeutics
  • Anca Mihaescu Associate Director, IT Computer Systems Validation , Jazz Pharmaceuticals Inc
  • Cory Brown Head of IT and GxP Digital, Tmunity Therapeutics Inc.

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 Close of GxP Cloud Compliance Summit