This second edition of a global best-seller has been completely redesigned and extensively rewritten to take into account the new Quality by Design (QbD) concept in pharmaceutical manufacturing. As in the first edition, the analytical requirements during the entire product lifec…
"Presents the important components of writing and managing documents for the clinical laboratory. This guideline describes common and specific sections for inclusion in laboratory documents. Several examples of process and procedure documents for preexamination, examination, and…
Public concern over high-profile mistakes in IVF clinics and the concomitant increase in governmental regulation, have given rise to widespread recognition of the need for accreditation of IVF clinics. Modern accreditation schemes are largely based on the principles of ISO 9001 …
A practical guide, for use by laboratory workers in health centers and district hospitals, to the procedures to be followed in obtaining specimens, isolating and identifying bacteria, and assessing their resistance to antibiotics. It covers bacteriological investigation of blood…