Pre-Conference Workshop Day

Tuesday | July 12

Workshop A - 10:00am-12:00pm

Moving from Computer System Validation to a Computer Software Assurance Model

The FDA's updated CSA framework is changing the paradigm on how computer system validation is performed. Designed to help manufacturers achieve compliance through their digital transformation journeys - from electronic document workflow using electronic signatures to the implementation of artificial intelligence - the new CSA draft will provide clarity on the stance and methodology used to determine what is high risk and what is not, therefore minimizing misinterpretation by manufacturers.

The clarification in the CSA approach flips the model to focus on
critical thinking (risk-based), assurance needs, testing activities, and
documentation, in that order.

Join this workshop to:
• Identify the best and most effective strategy for your transition in line with FDA guidance
• Prepare for the FDA's new documentation requirements
• Update your business processes to focus on quality assurance,
patient and product safety, and data integrity

Workshop B - 1:00pm-3:00pm

Understanding General Data Protection Regulations (GDPR) for Cloud-Based Computer Services in the Life Science Sector

GDPR requires companies to protect the personal data of their customers and employees at all stages of the data processing lifecycle. With more life science companies adopting and using cloud-based tools for storing their data, complying with this requirement is becoming increasingly challenging. Maintaining GDPR compliance is no easy task, and life science companies need to take different technology and legal aspects into consideration when implementing GDPR.

Join this workshop to:
• Understand the fundamentals of GDPR
• Leverage what is personal data and sensitive personal data
• Define your methods for how to implement data protection
policies

Yves has been performing computerized system validation (CSV) since 1992. He is the editor of the French Version of GAMP® 4 and GAMP® 5. He is the co-founder and chair of GAMP Francophone and member of GAMP Europe Steering Committee (GESC). At ECA (European Compliance Academy) Yves is member of the Data Integrity and IT Compliance Group.