In today’s world of record-breaking merger and acquisition activity, management of change, especially relating to GXP compliance is essential. Many do this poorly with a reported failure rate of 70%. However, the risks associated with integration can be significantly reduced with proper planning and execution. Whitney Sandberg and Eldon Henson...
IVT Network remembers Scott Sutton, a premier microbiologist, IVT Network Advisory Board Member, event speaker, friend and mentor to many.
Dr. Sutton's valuable work in the pharmaceutical industry will not be forgotten, and you can view samples of his greatest pieces here.
This feature provides a forum for validation managers and associated personnel to share information about documents associated with the validation function.
Cleanrooms, laboratory areas, isolators and biosafety workspaces (microbiological safety cabinets) require a level of cleanliness and microbial control (achieved through disinfection) according to the intended use of the area.
This paper assesses the current technologies and process steps required for the effective biodecontamination of...
Are you correctly implementing equipment for its intended use?
Regulated companies need to have formal equipment assessments that are consistently executed and documented according to an approved procedure. Ivan Soto reviews what is necessary in order to comply with the FDA Code of Federal Regulations and ICHQ10.