A conversation with Frank Henrichmann, senior executive consultant, Q-FINITY Quality Management, and a lead author of the ISPE GAMP Good Practice Guide: Validation and Compliance of Computerized GCP Systems and Data – Good eClinical Practice (Second Edition) As digital transformation…
An Interview With David Leichner David Leichner, CMO at Cybellum Attitude. Smile, say thank you, and always do the right thing. Often times we are confronted with some significant challenges in the workplace — always doing what is right vs.…
Verify that the following listed persons participated GAMP® Basic Principles 2-Day Training Course：Basic Principles of Computerized Systems Compliance: Applying the GAMP® 5 Guide: A Risk-based Approach to Compliant GxP Computerized Systems Second Edition (T07) 20230001 蔡洁莹 20230002 Yu Deyu 20230003…
The life sciences industry has always been focused on innovation. Pharmaceutical and biotech companies are constantly searching for new compounds to help cure or vaccinate against diseases or alleviate symptoms of other ailments. They spend billions on research and development,…
The Covid pandemic has pushed all companies to accelerate their digitization plans and ramp up adoption of emerging technologies. For regulated companies like Pharma, which operated in secure offices and fortified offshore development centers, this has also meant new ways…
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…
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…
ISPE is a global industry leader in scientific, technical, and regulatory advancement throughout the entire pharmaceutical lifecycle. As a result, ISPE is in a strong position and available to assist the US government, its allies, and like-minded regulatory partners with…