ISPE announced Juan Andres, Chief Technical Operations and Quality Officer of Moderna, Inc., as the confirmed closing keynote speaker for the 2022 ISPE Biotechnology Conference , taking place 28-30 June 2022 in Boston, Massachusetts and virtually...
ISPE announced the release of the Good Practice Guide: Continuous Manufacturing of Oral Solid Dosage Forms . This Guide reviews the unit operations typically employed in continuous manufacturing and aims to establish a set of minimum equipment...
ISPE today announced the 2022 Facility of the Year Awards (FOYA) Category Winners at the 2022 ISPE Europe Annual Conference in Madrid, Spain. Category Winners Include: CRISPR Therapeutics ( Innovation ) Janssen Biologics, BV ( Project Execution ) ...
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...
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...
ISPE announced three keynote presenters for the 2022 ISPE Aseptic Conference , taking place 14–15 March 2022 in North Bethesda, Maryland and virtually. Now in its 31st year, this signature event has established itself as the pharmaceutical industry's...
ISPE announced Matthew Hepburn, MD, Senior Advisor to the Director, Pandemic Prevention, U.S. Office of Science and Technology Policy (OSTP), Executive Office of the President, as a confirmed keynote for the 2022 ISPE Facilities of the Future...
ISPE announced the release of the ISPE Good Practice Guide: Controlled Temperature Chambers – Commissioning and Qualification, Mapping and Monitoring (Second Edition) . This Guide was written to meet changing industry practices, as global...
ISPE announced experts from leading pharmaceutical manufacturing organizations and agencies, including BioNTech, Catalent Pharma Solutions, CDER/FDA, Gilead Sciences, Inc., Merck, Nephron Pharmaceuticals, and The White House, will convene for the...
ISPE announced the release of the ISPE Guide: Advanced Therapy Medicinal Products (ATMPs) – Autologous Cell Therapy , a first-of-its-kind guide about the development and design of manufacturing facilities for ATMPs. ATMP therapies include cells...
