SOLD OUT—Waiting List Only
All pricing is per person.
See information below about government employee and group rate discounts.
This 2-day workshop provides comprehensive and highly interactive training in current regulatory expectations and industry approaches to ensuring Data Integrity and compliance with 21 CFR Part 11, with a specific focus on electronic data and computerized systems. Example topics include:
Data Integrity -- Risk-Based Approach to Preventing & Detecting DI Risks
Data Life Cycle and Data Process Design and Controls
Data Integrity Governance Compliance Plans and Accountability Structures
Management Governance & Quality Culture
Validation for Data Integrity
21 CFR Part 11: Electronic Records, Electronic Signatures
EU Annex 11
Health Authorities' Data Integrity Guidances
Techniques to Identify and Investigate Aberrant Data Patterns
Reviewing electronic data and metadata--such as audit trails
Risk assessment tools
Preparing for FDA inspections of facilities and electronic data
Case study of hands-on live system audit to detect data integrity issues
And much more
The Level 1 workshop is designed for personnel responsible for data integrity (i.e., those who create, review and approve data in any CGxP Operational role)—as well as novice and advanced Quality & Compliance auditors, Health Authorities, System Users, IT professionals, CSV and Engineering, Management, and more. Participants will have the opportunity to discuss recent industry standards, regulations and guidances and current regulatory expectations, case studies, audit and inspection approaches, assessment tools, and FDA 483s and warning letters. Participants will also be able to conduct a hands-on inspection of a live computerized system to detect data integrity issues and define appropriate corrective and preventative actions.