FDA Warning Letters and 483 observations show that data integrity failures involving pharmaceutical quality control and analytical development laboratories continue unabated.
One major weak point is that, sometimes, just placing a purchase order for an instrument or system can result in a regulatory citation even before an inspector visits.
Even if you purchase an apparently compliant system, the way you use it can also trigger an FDA observation.
To see what your company needs to do to address the latest regulatory data integrity findings in the laboratory, download a recording of the May 24 Redica Systems webinar, “Are Laboratories Perpetuating Data Integrity Problems?” that featured presenters Paul Smith and Bob McDowall.
What You Will Learn
- Analysis of over 100 FDA 483 observations and Warning Letter citations involving infrared spectrometers
- Learning points for purchase of new analytical instruments
- Guidance from WHO for process improvement and business efficiency gains while meeting data integrity objectives
- PIC/S guidance for avoiding perpetuating data integrity problems
- Why suppliers play a critical role in preventing data integrity issues in the laboratory
About the Experts
Paul Smith has a passion for laboratory compliance. He started his career as an Infrared Spectroscopist, interpreting FT-IR and Raman spectra and applying chemometric modeling tools to the data. His first software validation work was in 1992, before moving into broader analytical chemistry, project, and laboratory management roles. In his current Agilent Technologies role, he monitors laboratory compliance change and non-compliance trends, regularly contributing and writing journal articles related to laboratory compliance and analytical instrument qualification/USP <1058> Analytical Instrument Qualification.
Bob McDowall is an analytical chemist with 50 years of experience, including 15 years working in the pharmaceutical industry, followed by 29 years working in the industry as a consultant. He has over 35 years of experience in automating laboratories and computerized systems, mainly involving analytical systems and laboratory informatics.
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