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Thank you to our keynote speakers who kicked off the 2020 ISPE Annual Meeting & Expo this morning with compelling and insightful presentations:
Watch this short clip of Paul McKenzie’s presentation “Engineering and the Pandemic: Lessons for the Future of How We Work” to hear him share 1 of 5 lessons learned.
Watch Dr. Hahn, Commissioner USFDA, discuss challenges in pharma industry during the 2020 ISPE Annual Meeting & Expo.
During the 2020 ISPE Annual Meeting & Expo session “Agile Project Delivery for Cell & Gene Therapy Facilities,” Byron Lindros, Director Capital Projects, Kite Pharma, and Scott Bertch, Sr. Director of Technical Operations, AveXis, Inc., walked us through project management best practices in delivering cell and gene therapy facilities.
In this clip, Byron answers the question: Why develop an engineering project delivery (EPD) model?
Thank you to Bausch+Ströbel GmbH + Co. KG, Virtual Platform Supporter for this session.
Is PharmaLedger the only blockchain initiative under IMI - Innovative Medicines Initiative or are there other ones?
Watch this clip to hear from Daniel Fritz, Domain Architect Supply Chain & ESO - PharmaLedger Industry Project Lead, Novartis. Plus, hear additional thoughts on blockchain from James Canterbury, Principal, Consulting, EY, and John Bass, CEO, Hashed Health, during the 2020 ISPE Annual Meeting & Expo session “Blockchain: The GAMP® Aspects.”
What does risk analysis and risk management look like when you’re doing the development of pre-filled syringes and pen injectors?
Johnson & Johnson, posed this question during the 2020 ISPE Annual Meeting & Expo session “Combination Products Part 1: An Industry Perspective.”
Watch this clip to hear Vetter Pharma, and Tobias Nemeth, Director Primary Packaging Service & Projects, Vetter Pharma, answer this question.
Clearly defined business rules and metrics derived from these rules will form an important foundation to efficiently detect potential data integrity problems during review for early intervention before they impact quality and safety.
In this clip from the 2020 ISPE Annual Meeting & Expo session “GAMP® Data Integrity by Design Part 2,” Rob Dillman, Informatics Specialist-Data Integrity, Eli Lilly and Company, highlights examples of business rules.
Approximately 25% of all NCEs are classified as high-potency with OELs (occupational exposure limits) below 10ug/m3 with this number expected to grow. Typically, pharmaceutical companies will either outsource high-potency products (40% of all outsourced products are classified as high-potency) or create dedicated facilities.
In this clip of the 2020 ISPE Annual Meeting & Expo session “Flexible and Modular Manufacturing,” Emily Gullotti, Associate Principal Scientist, Merck, gives us look into Merck’s innovative strategy to build the FLEx Center (Formulation, Laboratory and Experimentation Center), a new, state-of-the-art facility with flexible, high-potency manufacturing to include both modular and podular design features.
Watch Now: During the 2020 ISPE Annual Meeting & Expo presentation “Trimming the IT Quality Management System to Do More in Pharma 4.0,” Levi Schenk, M.S., CSM, CSSBB, Manager IT Quality Governance, CSL Behring, discussed the processes to embrace Pharma 4.0™.
FDA Commissioner Stephen M. Hahn, MD, spoke about the lessons learned from COVID-19 in a presentation during the ISPE Annual Member Meeting on 5 November at the 2020 ISPE Annual Meeting & Expo. He discussed how the FDA has been responding to the pandemic, including how actions taken in response to the pandemic have been combined with FDA knowledge from prior public health crises to...
The 2020 ISPE Member Meeting included most of the usual components of live Member Meetings: Outgoing ISPE International Board of Directors Chair Frances Zipp passed the gavel to incoming Chair Joanne Barrick, new Board members began their terms, Board members completing their terms departed, and ISPE members received a report on the state of the Society’s business.
The COVID-19 pandemic has brought increased harmonization and interaction among regulators around the world and the opportunity to consider changes implemented during the pandemic for the long term. Six regulators from five regulatory agencies discussed these issues at the “Global Regulatory Town Hall–The Impact of a Pandemic on Harmonization and...
2020 and the COVID-19 pandemic have presented tremendous challenge to the world and the pharmaceutical industry—but from the pandemic has come stepped up development of vaccines and treatments, increased urgency to address supply chain challenges, and forging ahead to develop and expand of cell and gene therapies. There are lessons to learn from the industry adaptation during these months,...
