ISPE Shanghai Representative Office was setup early this year in Shanghai, which is an important milestone in the integration of China’s pharmaceutical industry with the international level. What is even more exciting is that ISPE announced the launch of a…
Certification THIS CERTIFICATE IS PRESENTED below list HAS COMPLETED GMP Auditing for Quality Assurance Training Course GMP Auditing for the Pharmaceutical Industry(G07) List GMP2025001 和金周 GMP2025013 Peng Nian GMP2025003 Yang Yi GMP2025004 Wang Wei GMP2025005 Wang Xinyu GMP2025006 Huang Wei…
Certification THIS CERTIFICATE IS PRESENTED below list HAS COMPLETED GAMP® Data Integrity 21 CFR Part 11, 2-Day Training Course A GAMP® Approach to Data Integrity, Electronic Records and Signatures, and Operation of GxP Computerized Systems (T70) List 20241201 庞宏 20241202…
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…