Danielle DeLucy, M.S.
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 this training, we will discuss effective batch record review and assurance to Data Integrity compliance.
Upon completion of this course, you will be able to:
This training is one part of the 10-course series required for the GMP Laboratory Control Professional Certification Program. Attend this course as part of the certification process or as a stand-along course for personal career advancement and training.
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This course is intended for professionals in the pharmaceutical industry who are charged with all aspects of maintaining compliant data integrity practices.
Personnel working in Quality Control, Manufacturing, Regulatory Affairs and Quality Assurance along with their management and supervisory teams, will greatly benefit from this training.
When you need on-site attention, we’re not just here to help, we’re there to help—right by your side.
Individual courses are remarkably effective. But sometimes when you have a specific need, it helps to have expert guidance right in the room with you and your team.
In that case, we’re happy to design a custom training for your entire team, whether online—or on-site.
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