Data Integrity for the Laboratory and Beyond - Careful Considerations for Your Next Audit

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 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. WHY SHOULD YOU ATTEND In recent years, FDA has increasingly observed CGMP violations invo... Read more

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 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. 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. Attendees will obtain an understanding of the regulatory expectations for data integrity compliance. AREAS COVERED • 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 data integrity risk assessment • Learn about approaches to improve data integrity in a laboratory environment LEARNING OBJECTIVES The information provided at the webinar will enable the attendees to review practices at their own site and identify gaps in their own practices for maintaining data integrity compliance. WHO WILL BENEFIT • Site Quality Operations Managers • Quality Assurance personnel • Plant Managers and Supervisors • Manufacturing Superintendents and Managers • Regulatory Affairs Managers SPEAKER 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. To Register (or) for more details please click on this below link: http://bit.ly/30ZhEt3 Email: support@trainingdoyens.com Toll Free: +1-888-300-8494 Tel: +1-720-996-1616 Fax: +1-888-909-1882