2019 - Implementation and Management of GMP Data Integrity

Overview
Data integrity is the assurance that data records are accurate, complete, intact and maintained within their original context, including their relationship to other data records. This definition applies to data recorded in electronic and paper formats or a hybrid of both.
Why should you Attend
In recent years, FDA has increasingly observed CGMP violations involving data integrity during CGMP inspections.
These data integrity-related CGMP violations have led to numerous regulatory actions, including warning letters, import alerts, and consent decrees. Attendees will obtain an understanding of the Regulatory expectations for Data Integrity.
The information provided at the webinar will enable the attendees to review practices at their own site and identify gaps in their own practices.
Areas Covered in the Session
Understand the current regulatory position on data integrity
Discover the criteria for data integrity
Recognize what needs to be addressed to ensure data integrity within a regulated GXP laboratory
Learn about approaches to improve data integrity in a laboratory environment
Who Will Benefit
Site Quality Operations Managers
Quality Assurance Personnel
Plant Managers and Supervisors
Manufacturing Superintendents and Managers
Regulatory Affairs Managers
Speaker Profile
Danielle DeLucy MS, is owner of ASA Training and Consulting, LLC which provides Pharmaceutical and Biologics based companies with training and quality systems assistance in order to meet Regulatory compliance. Prior to this role, Danielle has been in the industry for 17 years serving in numerous Quality Management Roles, such as the Director of Product Quality, the oversight of Sterility Assurance practices and provided QA oversight of numerous filling and packaging operations.