Standard operating procedures (SOPs) have become the documentation backbone of our industry and, yes, at times, a major pain in the neck. Those of us who were around during the 80s may be able to recall fuzzy memories of SOPs being a thing . Fast forward to 2019, past the birth of ICH, the evolution of outsourcing, the techno explosion and the FDA’s 21 CFR Part 11, the EU obsession with quality systems, and the more recent rise of the big vendor. Today, we’re buried in mountains of SOPs.
Global biopharma regulations and guidelines require that individuals involved in conducting clinical trials be qualified by a combination of education, training, and experience. The components are straightforward to implement regarding internal employees, but not so clear when it comes to part-time consultants contracted to intermittently execute specific good clinical practice (GCP) tasks. Discover three trips for training independent consultants.