Cybersecurity and Pharma 4.0 CSV implications

Friday -June 26, 04.00 pm IST


About the Educational Session 

Learn how to navigate the complexity of cybersecurity within Pharma 4.0 for IT and OT environments according to GAMP 5 best business practices when adhering to international security standards like ISA99 Industrial Automation and Control Systems Security and ISA/IEC 62443 framework Security for Industrial Automation and Control Systems under a governing ISO 27001/27002 Information Security Management System or NIST structure. Specific topics that will be covered in line with GAMP 5 methodology are: 

1. Initial risk assessment

2. How to generate user requirements and functional/design specifications

3. The implications of cyber security during installation and operational qualification testing

About the Subject Matter Expert

Jason Young is a Cyber Security Architect and has been working within the information security field for more than 20 years. Jason is currently the leader of the SIG within the ISPE for cybersecrity. Jason’s doctoral studies at Deakin University include research in the integration of infomration security frameworks to the GxP validation processes for the pharmaceutical Industry. He began his career in information security while serving in the U.S. Military when the necessity for both offensive and defensive cyber operations was becoming apparent in 2001. He fell naturally into the role with a passion for anything technology related. 

Jason has also authored two publications for the SANs Institute on gaps within the GxP process for cyber security. With a background mostly in network security operations prior to becoming a cyber security architect, Jason has also worked collaboratively on creating the U.S. Army Europe’s courseware for Information Assurance and Computer Network Defense in 2006. Though Jason’s experience and training has been for the larger complex arena of enterprise level security operations, he thrives in small to mid-level environments where focus is on production and work done quickly and efficiently leading to the best results.