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 current Good Manufacturing Practices (CGMP) for US Food and Drug Administration (FDA)-regulated industry. Data integrity and security infractions are not only 21 Code of Federal Regulations (CFR) Part 11 issues but also severe CGMP violations. The reasoning behind this complex issue is quite simple: if the integrity of laboratory data is compromised, batches of finished goods may not comply with regulatory authorization terms and, consequently, will not be released for sale.
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. 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.
• Examples of data integrity pitfalls
• Part 11 compliance data integrity issues
Review of FDA citations related to data integrity
1. Understand the current regulatory position on data integrity
2. Discover the criteria for data integrity
3. Recognize what needs to be addressed to ensure data integrity within a regulated GXP laboratory
4. Learn about approaches to improve data integrity in a laboratory environment
5. Part 11 compliance
6. FDA citations related to data integrity issues
Quality Assurance/Quality Control Directors, Managers, and Specialists
Regulatory Affairs/Regulatory Compliance Directors, Managers, and Specialists
Engineering/Development Directors, Managers, and Specialists
Years of Experience: 19+ years
Areas of Expertise: Quality Management in Pharmaceuticals
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.
Danielle began her QA career as a Quality Control Pharmaceutical Microbiologist at a contract laboratory where she performed various tests for their clients. In the years after, she has held positions in the Quality management arena while increasing her responsibility. She has helped to lead many Regulatory Health Inspections and was instrumental in the coaching process of her peers prior to any inspection.
Currently, Danielle assists companies who are faced with warning letters, consent decrees and those wishing to improve compliance establish more robust quality systems so that the company can succeed.View all trainings by this speaker