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Presentation Archive

INTERPHEX 2016 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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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

PROCESS REQUIREMENTS DRIVE INNOVATION; MICROSPHERE CLASSIFICATION, FILTRATION AND DRYING
Michelle Frisch

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

REINVENTED ASEPTIC FILL-FINISH PROCESSING TECHNOLOGIES
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

INTERPHEX 2015 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.

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

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