by Sandy Weinberg, PhD
Volume 4, Issue 1 (January/February 2005)
New regulatory initiatives often produce paranoid responses. These over-reactions are often a result of initial rumors fueled by less-than scrupulous consultants or by misinterpreted statements reported out of context from unscripted regulators. The “remote monitoring capability” incorporated into the emerging Process Analytical Technology (www.fda.gov/cder/OPS/PAT.htm) initiative is a prime example. Put the fear back in the closet: remote monitoring will not lead to unannounced or secret FDA electronic visits, unscheduled remote audits, or regulatory spying on industry processing activities…
Citation:
Weinberg S. FDA Spyware in Your Processing? Implications of Remote Monitoring in a Process Analytical Technology Environment. BioProcess J, 2005; 4(1): 20-21.