<< Back to all Presentations
Share This:

Presentation Archive

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.


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

Intricacies of Shipping High Value, ultra-sensitive Pharmaceutical Processing Equipment: Avoiding pitfalls in the final presentation

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


Outcomes of Continuous Improvement Driving Technological Advances with Elastomer Closures
Tibor Hlobik

Trending Technologies in Sterile Product Manufacturing Facilities
Hite Baker

Using Optical Microscopy as an Orthogonal Method to Characterize the Gray Zone between Sub‐Visible Particle Counting and Visual Inspection for Injectables
Mark Berdovich

Healthcare Compliance Packaging Council
Walter Berghahn

Automated MES and DCS Excursion Management Collection System for Real-Time Excursion Resolution
Stephen Britton

Monitoring Disinfectants Residuals in Pharmaceutical Water Systems
Rich Bucha

Tailoring Training Solutions to GMP Processes
Dale Canning

Human Error Reduction Model: Root Cause Determination, CAPA development and CAPA Effectiveness Measurement for Human Performance Related Deviations
Ginette Collazo

Eliminating False Positives in Active Air Microbiological Environmental Monitoring: A Sterile Single-Use Impactor with an Integrated Agar Media Plate
Claudio Denoya

Case Study - Microbiological excursion during a phase I PQ of a WFI system
Walid El Azab

EU GMP change - impact on cleaning and process validation
Walid El Azab

Control Microbial Contamination and Understand the Implications on Batch Certification/Release
Walid El Azab

Industry Speaks: Transforming cGMP Manufacturing Facilities
DME Facility Focus

What is a Technology Transfer in Pharmaceutical Contract Manufacturing?
Norman Fong

Rapid Micro Detection - Part of Risk Based Lifecycle for Pharma/Biopharma Production for XXI Century
Igor Gorsky

The Evolution of Upstream Processing: Mitigating Risk through Single Use & Cell Culture Technologies
Josh Hays

Advances in Flexible Manufacturing Infrastructures and Facilities
Maik W. Jornitz

Influenza Hemagglutinin (HA) Quantification
Ben Levin

Feasibility testing, Cycle development and Validation Guidance for VHP Low Temperature Surfaces Terminal Sterilization Applications
Juha Mattila

Preparing for and Managing a FDA inspection
Joe McGinnis

High level disinfection and possible sterilization of computer hardware material using the flowing afterglow of a reduced-pressure N2-O2 discharge
Michel Moisan

Optimizing Biomanufacturing Operations; A Study in Single-use Implementation
Jeff Odum

Reusable Versus Disposable Textiles – Environmental Dimensions of Cleanroom Coveralls
Michael Overcash

Single-Use Systems for Critical Process Applications
Nathalie Pathier

Key Elements to Consider When Packaging Parenteral Products
Jeffrey Reid

Capital Requests - Start Your Project the Right Way
Dennis Romak

Automated Analysis of Hemagglutination and Hemagglutination Inhibition Assays
Nouara Sadaoui

Mike Salinas

Real Time Analytics for Facilities with Diverse Data Sources and Diverse Business Requirements
Terry Seanard

Extractables Evaluation of a Single-Use Bioprocess Bag According to Published Recommendations
Joseph StLaurent

Time-Accurate Modeling of Liquid Mixing and Blending: Application of the Lattice-Boltzmann Method
John Thomas

BPOG and BPSA User Requirements for Single Use Systems
Roberta Toporovski

Lowering Life Cycle Costs: From Front End Planning to a Zero Shutdown Goal
Rich Tree & Lou Traglia

How to Establish a Future-Proof Serialization Strategy to Comply with the DSCSA Regulation
Michael Urso

Case Study - New High Purity Water System Technologies Deliver Reliability & Sustainability for GSK
Steven Walter

Lean Strategies for Laboratory Testing
Jenny Watson

Cell Therapy Commercialization – How Do We Get There?
Eytan Abraham

Education and Training
Hal Baseman

Plant Retrofit of US Vaccine
Thomas Beutler & Yves Mayeresse

Comparative Study of Extractables Methods
Niraj Chandarana

Reduce Down Time with 3D Scanning
Nicholas Chwalek

The Global Track and Trace Challenge: Six Key Issues to Master
Graham Clark

Aging Facilities Modernization “Process Perspective”
Robert Dream

PDA Scientific and Regulatory Affairs
Josh Eaton

PDA Technical Report Overview
Josh Eaton

3D Systems Medical Solutions that Enable Patient Specific Instruments, Implants and Devices
Greg Elfering

Discussion of Processes Utilizing the Conical Rotor Processor
Shawn Engels

Novel Technologies for Human Blood Plasma Fractionation
Dieter Fassnacht

3D Printing 2.0 – The Applications of Today and the Opportunities Ahead
Daniel Fraser

3D Tissue Printer & Software
Michael W. Golway

Succeeding in Cell Therapy Commercialization: What is Needed and How Do We Get There?
Richard Grant

Why Innovative Drug Delivery Solutions are Needed for Today’s Patients
Kevin Haehl

Reducing the Risk Associated with the Filling of Biologics with Advanced Aseptic Processing
Bill Hartzel

Embracing Single Use as a Strategic & Manufacturing Philosophy
Bill Hartzel

PDA Intro and Overview of Aging and Modernization
Maik W. Jornitz

Considerations in Powder Filling
Dennis Martin

Counterfeit Drugs and Supply Chain Security
Rick Mitzner

Achieving Maximum Production Efficiency
Jim Mossop

State of the Art Multi-Layer Tableting
Fred Murray

Optimization of Feeding and Conveying Technologies for Difficult Flowing Pharmaceutical Powders
Sharon Nowak

Isolators, RABs and Mobile Clean Rooms in Aseptic Processing
Gary Partington

The Engineering & Business Advantages of 3D Printing
Greg Paulsen

Innovative Supply Chain Management Strategy for Enhanced Assurance of Supply, Quality & Change Control of Single Use Solutions
Paul M Priebe

Particles Causing End of Line Rejects and Drug Product Recalls: Overcoming Packaging Challenges and Need for Adequate Controls
Polywacz Riter

Reducing Risk, Cost & Facility Build Execution Through Use of Modular Facilities & Flexible Aseptic Processing Technologies
Mike Salinas

PDA Introduction and Overview: Aging and Modernized Facilities – An Analytic Perspective
Susan Schniepp

Advantages of Instrumented Tablet Presses
John Sturgis

Smarter Water – Maximizing Efficiency for Water Operations
Sean Sudol

The Road to Biologic IND Developing Your Discovery into a Product
Michiel E. Ultee

Stainless-steel vs Single-use: The Vaccines Perspective
Daniel C. Vellom

3D Printing: Hidden Costs You Need to Know
W. Daniel Fraser

Aging From a Facilities Perspective
Shelley Preslar

Summary and Readout Report from the 2015 Aging Facilities Workshop
Marsha Stabler Hardiman

We use cookies to operate this website and to improve its usability. Full details of what cookies are, why we use them and how you can manage them can be found by reading our Privacy & Cookies page. Please note that by using this site you are consenting to the use of cookies.