Webinar Duration: 60 minutes

RECORDED: Access recorded version only for one participant; unlimited viewing for 6 months (Access information will be emailed 24 hours after the completion of payment)

SPEAKER: Valarie King-Bailey

Computer systems used in highly regulated companies include sensitive and valuable information. Some of this information includes valuable electronic submissions, clinical information, medical device design control records, legal information, and other such information. Recent events have highlighted sophisticated cybersecurity attacks everywhere including the White House.Corporations have been attacked at an alarming rate. What does this mean for computer systems validation?

Validation engineers must reconsider testing strategies that provide objective evidence that computer systems have the requisite technologies, processes, and practices designed to protect networks, computers, programs, and data from attack, damage, or unauthorized access. Validation engineers must be more vigilant in today’s sometimes-hostile systems environment in order to detect cybersecurity issues before they become real problems. This webinar will focus on the regulatory, legal, compliance and business risks associated with the threat of cybersecurity. We will discuss the NIST Cybersecurity framework and how it can be applied to validated computer systems. We will also discuss a new level of qualification for validated computer systems known as Cybersecurity Qualification (CyQ). As validation engineers continue to conduct IQ, OQ, PQ, CyQ testing must be added as a defense against cyber attacks to validated computer systems.

Why should you Attend: Today’s headlines are filled with instances of cyber attacks resulting in denial of service, data theft or compromise and even ransomware holding critical data hostage while demanding payment. Is your company able to cope with a breach of one of your validated systems? How secure is your information in the cloud? Have you conducted adequate due diligence on your cloud provider? Increasingly life sciences companies are implementing and deploying systems in a cloud environment but lack the procedures and controls to effectively manage and protect their validated systems environments. This timely webinar will focus on the practical application of the NIST cybersecurity framework and its applicability in a validated systems environment.

We will address documentation and practical strategies to address cyber threats, roles and responsibilities among the validation/IT team members, and how to identify, protect, detect, respond and recover from a cyber attack on a validated system. This webinar will introduce the NIST cybersecurity framework as applied to validated computer systems. This session will include a deep dive into the core of the NIST framework categories which are Identify, Protect, Detect, Respond, and Recover. If you are a validation engineer, validation project manager or software quality engineer, you will not want to miss this important webinar.

Areas Covered in the Session:
– Understanding the NIST Framework
– Cybersecurity and Regulatory Considerations
– Risk Management and Cybersecurity
– Key Roles and Responsibilities
– Cybersecurity Qualification (CyQ) For Validated Systems
– Improving Security in Validated Computer Systems
– Best Practices For Cybersecurity in Validated Systems
– Understanding the REAL Threats
– Continuous and Repeatable Processes In Validated Systems Environments
– Understanding Your Cybersecurity Maturity
– 7 Steps To Cybersecurity Maturity

Who Will Benefit:
– IT Managers, Directors, VPs, Chief Information Officers
– Quality Assurance/Quality Control Managers
– Validation Engineers
– Validation Project Managers
– Program/Project Managers

Valarie King-Bailey is the CEO of OnShore Technology Group, an independent Chicago-based consultancy founded in 2004 specializing in Independent Validation and Verification (IV&V) services and solutions. OnShore’s flagship product, ValidationMaster™ is the first Lean Enterprise Validation Management & Quality System (EVMQ) on the market. ValidationMaster™ was recognized by CIO Review Magazine as one of the top 20 most promising technologies for life sciences in 2016. Valarie has worked for leading global companies such as QUMAS Limited (Ireland), EMC/Documentum, Abbott Laboratories and has been recognized as a leading global validation and compliance expert. She was recently honored as “Speaker of the Year” by the Institute of Validation Technology (IVT) and has received numerous awards for outstanding service in validation. Ms. King- Bailey holds an M.B.A. in Information Systems from Keller Graduate School of Management (1985) and a B.S. in Civil and Environmental Engineering from the University of Wisconsin – Madison (1982).

Valarie is a Distinguished Alumni and Lifetime Achievement Awardee of the U.W. College of Engineering. She is an active member of ISPE, the American Society of Civil Engineers, Society of Women Engineers, National Girls Collaborative Project for STEM education, and a U.W. College of Civil Engineering Advisory Board Member.