INTERPHEX 2018 featured more technical information and state-of-the-art technologies than ever before. See a sampling of presentations from the 3-day event below.
FDA Presentation: The Future of Pharmaceutical Quality and the Path to Get There
Lawrence X. Yu, PhD, Deputy Director of the Center for Drug Evaluation & Research's (CDER) Office of Pharma. Quality, United States Food and Drug Administration (FDA)
A Case Study for an Improved Approach to Cleanroom Disinfection, Minimizing the Impact and Reducing Downtime
James Tucker
A Molecule’s Journey – Breaking Down Roadblocks to Commercial Success
Cristian Cattaruzza
Achieving CPV Stage 3 With Industry 4.0 Manufacturing Analytics
Peter Guilfoyle
Cleaning Validation – Different Approaches to Limit Setting for Detergents
Thomas Altmann
Continuous Manufacturing for Solid-Dosage Drugs
Dennis Powers
Data Integrity – Understanding GMP & FDA Requirements and Becoming Compliant
Daniele Pandolfi, Parsa Famili
DME – Best Industry Practices for Retrofitting Legacy Filling Lines with RABS Barriers
Hite Baker, John Erdner, Lee Edwards, Steve Nole, Alexander Haig, Massimiliano Csarini
DME - Flexibility by Design: GMP Manufacturing for the Diverse Product Portfolio
David Marks, Daniel Rudolph, Leo Krieg, Sean Illig
Ensuring reliable, consistent production in pharmaceutical water systems
Per-Åke Ohlsson, David Summers, Alfa Laval
Harmonized Method for Cleanroom Hard Surface Disinfectant Efficacy Evaluations
Rachel Blount
Information Technology Trends and Best Practices – The Industrial Internet of Things, Blockchain and Smart Contracts
Bob Celeste
Integrating IoT into your Life Sciences Packaging and Supply Chain Strategy - Best Practices to Take this Valuable Leap
Attilio Bellman
Internet of Things (IoT) for Cold Chain
Jim Sabogal
Maximizing the Potential of Manufacturing Data to Advance Biopharmaceutical Production
Anja Zgodic, Ashley Lee, Paul Stey, Andras Zsom, Sam Bell, Tom Mistretta, Patrick Gammell
On-dose Identification for Tablets and Capsules
Edward S. Novit
PDA Update on Pre-Use Post-Sterilization Integrity Testing
Maik Jornitz
Process Analytical Technology and My Dosage Design™ Tool to Measure Functional Film Coating thickness on Multiparticulate Coating
Piyush Patel
Process Economics: The Driving Force Behind the Criteria for Cell Therapies Facility Design
Eric Bozenhardt
Real-Time Analytics with Timeline View for Improved Analytics
Joe Bastone
Single Use Applications in Continuous Biopharmaceutical Processing
Ali Klein, Craig Sandstrom
Streamlined Manufacture of Modified Release Matrix Tablets via Direct Compression
Katie Hewlett, Gus LaBella
TEC E2E Freeze/Thaw Platform
Jeff Johnson
The use of extractables data from single use components for risk assessment
Dr. Sade Mokuolu
INTERPHEX 2017 featured more technical information and state-of-the-art technologies from industry SMEs than ever before. See a sampling of presentations over the 3-day event below.
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Assessing the Impact of Single Use Systems on Patient Dafety ELSIE's perspective on a systematic, comprehensive approach to safety evalutaion
Jessica Shea, George Adams, Thomas Broschard
Avoid recurrent microbial contamination using trending of historical data
Walid El Azab
Beyond Fill & Finish: How Market Demands and Regulatory Requirements are expanding the Deliverables of Traditional Sterile Fillers
Kimberlee Steele
Biosafety Considerations for Single Use Technology
Brian Petuch
Buffer Make-up Comparisons: Continuous Inline vs Cycling Batch
Greg Lepak
Design and Application of local energy efficient humidity systems control of diverse load areas on a shared central system by use of various Ultrasonic Humidifiers
Susan Morrison
Developing and Transferring Remote Swab TOC Method
Kate Boswell
Enhancing Packaging Line Efficiency for Improved Equipment Performance
Wen Jian Lee
How Scientific companies use the Supply Chain Management model to link human capital to business needs to increase productivity and efficiency
Harvey Yau, Jeffrey Garvin, Natalie Karsti
Impacts on Facilities and Process Support from Continuous Processing
Melinda Covert, Craig Sandstrom
Implementing Continuous Manufacturing for Solid-Dosage Drugs: Different Approaches to Continuous Manufacturing within the Pharmaceutical Industry
Bayan Takizawa
Improve Hygiene, Reduce Slip Fall Risks & Speed Up Maintenance Programs through Innovations in Floor & Wall Coating Systems
Richard Kroger
Improving API yield with new revolutionary particle agglomeration enhancing cyclone geometries
Julio Paiva
Incorporation of Particle and Microbial Detection into Environmental Monitoring Systems
Paul Hartigan
Industrial Biotechnology Facility Design: Defining manufacturing optimization opportunities using a design competition approach
Cramer
Intricacies of Shipping High Value, ultra-sensitive Pharmaceutical Processing Equipment: Avoiding pitfalls in the final presentation
Sanveley
Is It True, the European GMP Annex 1 revision will have no adverse Impact on resources or costs while supporting new technology implementation?
Walid El Azab
Modular and Flexible Facility Options: Examples and Case Studies
Maik W. Jornitz
Particle Size Measurement in Twin Screw Wet Granulation: An Analysis of the Value of In-line and At-Line Measurement Data
Mike Mulcahy
Process Control with the use of PAT: ControlLyo and TDLAS in Commercial Manufacturing
Paul W. Coiteux
Secure, Fast and Reliable Data Transfer: A Competitive Differentiator in the World of Genomic Sequencing
Gregory Hoffer
Serialization and Traceability- The Final Agenda: There's Still Time: Accelerated Compliance Program
Stephen Lisa
Single Use Facilities: Two Floors versus Three
Carl. J. Cramer
So Many Solvents, So Little Time: Making sense of industry and regulatory guidance on model solvents for extractable studies
Paul. F. Killian, PhD.
Steam or Dry Heat Sterilization- How to choose?
Marcel Dion
Time is of the Essence: Creating a new synergy between single-use adopters and suppliers
Celia Landers
Understanding ISO 14644-1/2: 2015 and become compliant
Danielle Pandolfi
Utilization of Supercritical Fluid Processing for Purification, Dissolution and Infiltration
Mike Favaloro