2020 ISPE Aseptic Conference
Thank You for Making this Conference a Huge Success!
The 2020 ISPE Aseptic Conference delivered engaging presentations and case studies on cutting-edge topics with many opportunities to network and gain insights from top industry professionals. Check out the content below to get insights from the conference.
Highlights of the FDA’s Actions and Activities in Response to the Coronavirus (COVID-19)
Hear from Alonza Cruse, Director, Office of Pharmaceutical Quality Operations, FDA/ORA, as he highlights some of the FDA’s actions and activities in response to the Coronavirus (COVID-19) at the 2020 #ISPE Aseptic Conference.
What Are Some of the Key Process Design Features That Are Needed for Autologous Cell Therapy?
Umit Verma, Vice President, Commercial Manufacturing, Iovance Biotherapeutics, Inc., offers his expert insights during his presentation Planning for The Unknown – Autologous Cell Therapy Scale Out Planning at the 2020 #ISPE Aseptic Conference.
What Does the FDA Want?
Having had a long career history with the FDA, David Doleski, Compliance Head for Biologics Quality Operations, Sanofi, provided his insight into the mindset of a regulator during his keynote presentation How Perspectives Change: From Regulator to Regulated at the 2020 #ISPE Aseptic Conference.
Adapting to Standardization of Extractables Testing for Single-Use Components
Hear from Laura Moody, Product Manager, Primary Packaging, NA, Syntegon, as she answers a question that came about from her presentation Adapting to Standardization of Extractables Testing for Single-Use Components at the 2020 #ISPE Aseptic Conference.
What Are Some Hot-Button Issues for the FDA?
Having had a long career history with the FDA, David Doleski, Compliance Head for Biologics Quality Operations, Sanofi, provided his insight into the mindset of a regulator during his keynote presentation How Perspectives Change: From Regulator to Regulated at the 2020 #ISPE Aseptic Conference.
Testimonials
Session Highlights
Conference Highlights
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iSpeak BlogISPE 2020 Aseptic Conference - Day 1 The 2020 ISPE Aseptic Conference kicked off on schedule Monday 2 March with a full complement of programs, speakers, and more than 200 attendees, despite the spread of COVID-19 around the world. It was business as... -
iSpeak BlogThe 2020 ISPE Aseptic Conference starts in one week! Here's all the info you need to make the most of your experience. Conference Essentials Conference Agenda Travel Information Registration and Information Hours Sunday, 1 March | 1300–1700 Monday,... -
iSpeak BlogIf you work in the parenteral manufacturing space, it’s a foregone conclusion that you can pinpoint the emotion and anxiety that comes from receiving word that the FDA has arrived at your facility for an inspection. If Billy Joel were to pen the lyrics... -
iSpeak BlogI have been going to the ISPE Aseptic Conference since 2008 and the overwhelming response is that this is the best technical conference that ISPE hosts. The amount of learning, networking, and understanding that you can get at this conference is... -
iSpeak BlogAseptic filling of parenterals is one the most challenging tasks within pharmaceutical manufacturing. There is a wide range of topics that fall under this umbrella, from more engineer-driven topics like filling accuracy and machine performance to key... -
iSpeak BlogThe Aseptic Processing is facing the next generation of pharmaceutical products and GMP requirements. The Annex 1 draft is in the final stage and we expect the publication before the next ISPE Aseptic Conference in North Bethesda, MD. The Annex2/PICs... -
iSpeak BlogThe world is getting smaller due in no small part to the technological advances. Pharmaceutical Manufacturing is moving in parallel with this trend—smaller batch sizes and personalized medicines are the trend on the horizon. But some producers, small has... -
iSpeak BlogHow do we best design a production facility for advance therapeutic medicinal products (ATMPs)? How about high-potent products that need to be sterile? And what are the latest developments in Barrier/Isolator technology? We will try to answer all these...
Program Committee
