Online Webinar 2019 - 10 Sure-Fire Tips for Implementation and Management of GMP Data Integrity Any Investigator Would Love

Session Highlights
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
Part 11 compliance
FDA citations related to data integrity issues
And much more !
Who Will Benefit:
The following professionals from FDA regulated industries will benefit from this training:
Site Quality Operations Managers
Quality Assurance personnel
Plant Managers and Supervisors
Manufacturing Superintendents and Managers
Regulatory Affairs Managers
Why Should You Attend
In recent years, FDA has increasingly observed CGMP violations involving data integrity during CGMP inspections. This is troubling because ensuring data integrity is an important component of industry’s responsibility to ensure the safety, efficacy, and quality of drugs, biologics and medical devices. These data integrity-related CGMP violations have led to numerous regulatory actions, including warning letters, import alerts, and consent decrees.
In this webinar 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.
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. To assure the quality of raw materials, in process materials and finished goods, laboratory data integrity is assuming greater importance in CGMP for US FDA regulated industry. Data integrity and security infractions are not only 21 CFR Part 11 issues but also severe CGMP violations.
Faculty: Danielle DeLucy Owner, ASA Training and Consulting, LLC
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 15 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.