iSpeak Blog
2020 ISPE Aseptic Conference
Evolution in Aseptic Processing: Flexible and Reliable Solutions
Meet newly confirmed keynote for the 2020 ISPE Aseptic Conference, Alonza Cruse, Director, Office of Pharmaceutical Quality Operations, FDA/ORA.
His office is responsible for all pharmaceutical quality inspections and investigations, working in conjunction with the FDA’s Center for Drug Evaluation & Research and the Center for Veterinary Medicine. Additionally, he is leading ORA’s pharmaceutical collaboration efforts under the Program Alignment initiative.
Alonza Cruse will provide current regulatory perspectives on aseptic processing during his keynote presentation, and answers your most pressing quality and regulatory questions directly with six FDA colleagues during the Interactive Regulatory Panel.
While many conferences just discuss the theoretical aspects of aseptic, barrier, and containment, the 2020 ISPE Aseptic Conference provides you with insights from aseptic professionals with 30+ years of experience, representing global companies that have implemented projects and technologies of peak interest.
Don't miss your chance to be immersed in collaborative, thought-provoking sessions featuring:
- Face-to-face interaction with the FDA
- Hot topic discussions
- Owner experiences and lessons learned
- Case study presentations
- Group breakout discussions
Sneak Peek of What to Expect
How will the new EC GMP Guide Annex 1 impact the future of aseptic processing? What are some of the latest developments in barrier/isolator technology?
Jörg Zimmermann, 2020 ISPE Aseptic Conference Chair, Vice President Vetter Development Service, External Affairs, Vetter Pharma-Fertigung GmbH & Co KG, answers these questions and more!
Conference Highlights
-
If 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...
Featured Sessions
-
ATMPs: Viral Vectors, CAR-T, and Production Approaches
Aseptic TrackSession leaders
Vice President, Vetter Development Service, External AffairsVetter Pharma-Fertigung GmbH & Co. -
Case Studies Part 2 - Flexible Fill & Finish, Validation of a Modular System, and Sterile API Manufacturing
Containment TrackSession leaders
-
Materials Transfer, Disposable Technology - Implementation, Risk Management and Testing Methods
Barrier TrackSession leaders
TOPICS
- Automated Visual Inspections
- Advanced Therapy Medicinal Products (ATMPs)
- Alternate Decontamination Technologies
- Aseptic Processing Science & Technology
- Cell Therapy Scale-Out Planning
- Cytotoxics, Robotics, High Potent Products
- Facility Design & Expansion Case Studies
- Formulation-Filling for Viral Vectors
- High-Speed Syringe Filling Expansion
- Modernization of a Legacy CDMO
- Robotic Applications in Aseptic Processing
- Small-Scale/Clinical Manufacturing
- Standardization of Extractables Testing
- Sterile Connectors & Materials Transfer
ISPE's work was the single most important thing in the evolution from the old legacy Aseptic processing operations to isolator technology and other barrier technologies.
Richard Friedman
Program Committee
Event Sponsors
