Training Doyens

D ata integrity related CGMP violations can led to numerous regulatory actions, including warning letters, import alerts, and consent decrees. Our upcoming webinar discusses how to review practices at your own site and identify gaps in your own practices for maintaining data integrity compliance. The webinar covers the following key areas: ·          Understand the current regulatory position on 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 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 • Qualit...

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  ha...