Microbial Data Deviation Investigations
: 8 Aug 2019
Type: Training, Webinar
Microbial data deviation investigations come in a multiplicity of forms and may vary from the very simple to include the incubation of a plate at an incorrect temperature to attempting to determine the "root cause" of a sterility test failure. The resultant investigations and their data requirements may be very short in duration, e.g. a matter of only several to 40-50 hours. However, unlike chemical analytical deviations and their Out Of Specification (OOS) studies and Corrective/Preventive Action (CAPA) programs, the length of time to complete these microbiological investigation studies may extend to as many as six months based on the laboratory studies that may be required.
This live interactive webinar will explore microbial data deviation investigations, the role of deviations, out of specifications, CAPAs and risk management within microbial data deviations and how the FDA and ICH regulations and guidances impact them.
- what are the more common microbiological data deviations.
- how do these deviations occur?
- what solutions exist for minimizing and eliminating these deviations.
- how a deviation becomes an oos and when a capa may be required.
- how the process may be shortened.
- how the use of metrics may provide a “roadmap” for action.
- why trending of deviations, oos and capas is important for both the site and during regulatory audits.
- the role of risk management and the relationship to microbial data deviation investigations