Microbial Data Deviation Investigations, Deviations, OOS, CAPAs and Risk Management
: 8 Aug 2019
Sector: Clinical, Pharmaceutical, Veterinary, Water
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.
The objective of this two hour live training webinar is to explore the more common microbiological aspects of data deviation investigations, and how FDA and ICH regulations and guidances impact them.