Learning Level: Basic/Intermediate Session Length: 1.5 hours The ISPE Good Practice Guide: Knowledge Management in the Pharmaceutical Industry places an emphasis on tacit knowledge – often referred to as know-how and know-why. A systematic KM program that manages tacit knowledge is…
Complimentary Learning Level: Intermediate/Advanced Session Length: 1.5 hours Process validation stage 1, also known as process characterization (PCS), is the main step of generating process knowledge that is reported in filings. Statistical and data science procedures are frequently employed and…
The 2022 Planning Committee is delighted to welcome attendance and registration for the fast-approaching ISPE Biotechnology Conference, taking place 28-30 June in Boston, Massachusetts and virtually. For more than seven years, this event has included participation from biopharmaceutical industry professionals, regulators,…
The life sciences industry is in the middle of a significant construction boom, partly fueled by research and manufacturing of vaccines and therapies to fight the COVID-19 virus and its variants. There are hundreds of new projects under construction, in…
ISPE announced the release of the ISPE APQ Guide: Change Management System. This Guide provides a quality management framework for assessing and advancing change management (CM) system maturity level by evaluating documentation, change/scope identification, change rationale, and more. Pharmaceutical companies are…
ISPE announced six regulatory speakers for the 2022 ISPE Europe Annual Conference, taking place 25–27 April 2022 in Madrid, Spain and virtually. The programme will feature a keynote address by Maria Jesus Lamas Diaz and two regulatory panel discussions with regulators…
Microbial quality encompasses sterility assurance—and more, as discussed by Joyce Hansen, Vice President of J&J Microbiological Quality and Sterility Assurance at Johnson & Johnson in the keynote at the Plenary Session, “Microbiology Quality and Cultivating Emerging Leaders” that kicked off…
The 2022 ISPE Aseptic Conference opened on Monday 14 March with keynote presentations by two regulators focusing respectively on PIC/S harmonization efforts (including the forthcoming Annex 1 revision) and FDA adaptations of operations through the pandemic and beyond. The two-day conference was…