QbD and PAT Topics at IFPAC 2014

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Which QbD or PAT topics interest you? I’ll be attending the IFPAC 2014 Conference in Washington DC. IFPAC began in 1987 and is relatively a small community of Regulatory Agencies, Manufacturers and Researchers focusing on Process Analytical Technology (PAT), Quality by Design (QbD), Process Understanding & Control, and Real-Time Analytics. Sharmista Chatterjee, Ph.D. of FDA, CDER, OPS, ONDQA, put it as “a group of people who can talk about QbD and PAT for hours.” Dr. Chatterjee is the co-chair of IFPAC and she personally invited me to present at the conference (Wednesday PM III: Risk Management over Product Lifecycle. Topic: “Risk Assessment for QbD: Why FMEA Fails“). Thank you Sharmista!

Are you attending? Then please leave a comment below so we can meet in person.

Unable to attend? Here’s the good news. If there is enough interest in certain sessions and I happen to be available during that time, I can be the eyes and ears for you. I like to share my learning with the QbDWorks community.

How will you make this happen?

Please comment below on which session you are interested in. This is the only way I’ll know which topics interest you.

Below is the full program schedule. (source: IFPAC.com)

Whether you are attending or not don’t forget to leave a comment!

IFPAC Preliminary Program 2014
Jan. 21 – Jan. 24, 2014

Tuesday PM

Pre-Conference Workshop: Control Strategy in Continuous Manufacturing (1:00PM to 5:00PM (included in the standard conference fee)

Chair(s): Christine Moore, FDA, Sharmista Chatterjee, FDA and Theodora Kourti, GSK

As continuous manufacturing is being adopted in the pharmaceutical industry, considerations for developing the Control Strategy need be addressed. Speakers from industry will discuss considerations for developing the control strategy for continuous manufacturing of Drug Product and Drug substance. Specific points to consider related to process control in continuous manufacturing will be presented by an academic speaker. Finally regulatory perspectives will be presented by FDA and EMA.

Open to All!

	Introduction to Workshop/Welcome
	Theodora Kourti, GSK

	Introduction to Topic
	Christine Moore, FDA

	Process Control in Continuous Manufacturing
	Richard Braatz, MIT

	Control Strategy in API Continuous Manufacturing
	Paul Collins, Eli Lilly

	Control Strategy in Continuous Manufacturing of Drug Product
	(TBA), Vertex

	Regulatory Perspective on Control Strategy of Continuous Manufacturing
	Rapti Madurawe, FDA (TBA), EMA

	Panel Discussion
	Evdokia Korakianiti, EMA and all speakers

Wednesday AM

Plenary Session: IFPAC/QbD/PAT/ONSITE

Chair(s): Sharmista Chatterjee, FDA, Mark A. LaPack, Gawayne Mahboubian-Jones and Paul Vahey

	Welcome/Introduction
	Sharmista Chatterjee, FDA, Mark A. LaPack, Gawayne Mahboubian-Jones and Paul Vahey

	How Quality by Design and Associated Enabling Technologies Influence Business Strategy
	Christopher Sinko, Ph.D., Senior Vice President, Bristol-Myers Squibb, Princeton, NJ

	Leveraging Real-time Big Data: From the Inspect & Reject Paradigm to Predict & Prevent
	Jim Petrusich, Vice President, Northwest Analytics, Manufacturing Intelligence for Intelligent Manufacturing, Portland, OR

	CDER’s Office of Pharmaceutical Quality (OPQ): Delivering on the 21st Century Quality Goals
	Lawrence X. Yu, Ph.D., Acting Director, Office of Pharmaceutical Science, FDA, CDER, OPQ, Silver Spring, MD

	Continuous API Synthesis: Development, Optimization, and Scaling
	Klavs F. Jensen, Warren K Lewis Professor and Department Head Department of Chemical Engineering, MIT, Cambridge MA

	OnSite Key Note Presentation – The Great Merger: Integrating Chemical Sensing for Responsive Detection of Future Threats
	Augustus W. Fountain, III, Ph.D., Senior Research Scientist (ST) for Chemistry, Edgewood Chemical Biological Center, Aberdeen Proving Ground, MD

	New Chemistry, New Science for Industrial Innovation
	Professor George M. Whitesides, Department of Chemistry & Chemical Biology, Harvard University, Cambridge, MA

Wednesday PM I

Continuous Manufacturing

Chair(s): Vibhakar Shah, FDA and Theodora Kourti, GSK

Experimental Investigation of Granule Shape and Size Dynamics in Twin-screw Granulation

Ashish Kumara,b, Jurgen Vercruyssec, Krist V. Gernaeyd, Thomas De Beerb, , Ingmar Nopensa, a. BIOMATH, Dept. of Mathematical Modelling, Statistics and Bioinformatics, Faculty of Bioscience Engineering, Ghent University, Gent, Belgium, b. Laboratory of Pharmaceutical Process Analytical Technology, Dept. of Pharmaceutical Analysis, Faculty of Pharmaceutical Sciences, Ghent University, Ghent, Belgium, c. Laboratory of Pharmaceutical Technology, Dept. of Pharmaceutics, Faculty of Pharmaceutical Sciences, Ghent University, Ghent, Belgium, d. Center for Process Engineering and Technology, Department of Chemical and Biochemical Engineering, Technical University of Denmark, Lyngby, Denmark

Experimental Investigation of Residence Time Distribution in Twin-screw Granulation

Ashish Kumara,b, Jurgen Vercruyssec, Maunu Toiviainend, Panouillot Pierre-Emmanueld, Mikko Juutid, Valerie Vanhoornec, Krist V. Gernaeyd, Thomas De Beerb, , Ingmar Nopensa a. BIOMATH, Dept. of Mathematical Modelling, Statistics and Bioinformatics, Faculty of Bioscience Engineering, Ghent University, Gent, Belgium, b. Laboratory of Pharmaceutical Process Analytical Technology, Dept. of Pharmaceutical Analysis, Faculty of Pharmaceutical Sciences, Ghent University, Ghent, Belgium, c. Laboratory of Pharmaceutical Technology, Dept. of Pharmaceutics, Faculty of Pharmaceutical Sciences, Ghent University, Ghent, Belgium, d. Optical Measurement Technologies, VTT Technical Research Centre, Kuopio, Finland, e. Center for Process Engineering and Technology, Department of Chemical and Biochemical Engineering, Technical University of Denmark, Lyngby, Denmark

	Development of a Continuous Tableting Process by Understanding Granule Properties
	Andrew Birkmire, GEA Process Engineering, Inc., Columbia, MD

	A QbD Approach to Continuous Tablet Manufacture
	Tim Freeman, Freeman Technology Inc., Tewkesbury, Gloucestershire, United Kingdom

	A Pilot Scale Continuous Manufacturing Line: Case Studies for the Process Performance Evaluation
	Simo-Pekka Simonaho, University of Eastern Finland, Kuopio, Finland

Process Monitoring and Modeling of a Continuous Pharmaceutical from Powder to Tablet Process Line using a Mass & Energy Balance

Thomas De Beerb, Severine Mortiera,b, Krist Gernaeyc, Ingmar Nopensa aBIOMATH, Department of Mathematical Modelling, Statistics and Bioinformatics, Faculty of Bioscience Engineering, Ghent University, Ghent, Belgium, bLaboratory of Pharmaceutical Process Analytical Technology, Department of Pharmaceutical Analysis, Faculty of Pharmaceutical Sciences, Ghent University, Ghent, Belgium, cCenter for Process Engineering and Technology, Department of Chemical and Biochemical Engineering, Technical University of Denmark, Lyngby, Denmark

	Utilizing Early Development and QbD in PAT Method Development for Continuous Processes
	Justin Pritchard, Vertex Pharmaceuticals, Inc., Cambridge, MA

	Process Control in Continuous Processes
	Martin Warman, Vertex Pharmaceuticals, Inc., Cambridge, MA

Wednesday PM II

Rapid Micro Methods (RMM) for Manufacturing Roles

Chair(s): Jeff Weber and Bryan Riley, FDA

	RMM Applications (TBA)
	Amy McDaniel, Pfizer

	A Rapid Microbiological Method – RMS for Application in Manufacturing
	Bill Puent and J.P. Jiang, Instant BioScan, Tucson, AZ

	RMM Applications – QbD and PAT (TBA)
	Jon Yourkin and Rick Godec, GEA

	RMM’s for Manufacturing: Defining the Gaps…How PAT should embrace RMM
	Jeffrey W. Weber, Pfizer Global Supply, Portage, MI (double session)

	Check on our web pages for updates on this session www.IFPACPAT.ORG

Wednesday PM III

Risk Management Over Product Life Cycle – I

Chair(s): G. K. Raju and Rick Friedman, FDA

	Risk Management for Breakthrough Therapies (TBA)
	Sarah Pope, FDA, Silver Spring, MD

	Development & Implementation of Biologics Control Strategy
	Mariah Deguara, Pfizer

	Quality Risk Management Inspection Perspective
	Rick Friedman, FDA, Silver Spring, MD

	Quality Risk Management: Review Perspective
	Celia N. Cruz, Ph.D., Office of Pharmaceutical Science, USFDA, Silver Spring, MD

	Quality Risk Management
	Ulrika Henningsson, Astra Zeneca

	Perspectives in Development, Technology Transfer and Commercialisation – Product & Process Modelling Concepts to Support Risk Management
	Sander van den Ban, GSK

	Why Risk Assessment in QbD is Painful and Ineffective: A QFD Approach
	Sun K. Kim, Bayer Healthcare, Berkeley, CA

	Risk Management over Product Life Cycle – Panel Discussion
	G. K. Raju, Rick Friedman et al.

Wednesday PM IV

International Harmonization on QbD: Recent Experience

Chair(s): Christine Moore, FDA and Evdokia Korakianiti, EMA

	This half day session for IFPAC-2014 will focus on European, Japan and USA Agency perspectives and the lessons learned. It will include what we need to see as regulators and the concerns for implementing and the submissions. Formal speaker presentations will be followed by an in-depth panel discussion.

	General Update about the FDA-EMA QbD Pilot
	TBD, EMA, UK

	Learning’s from the Pilot to Date – Q&A Documents
	Sharmista Chatterjee, FDA

	The Current Status of the QbD Application in Japan and PMDA Comments on the Q&As
	Junichi Fukuchi, Ph.D., Office of Cellular and Tissue-based Products Pharmaceuticals and Medical Devices Agency (PMDA)

	Industry Experience Regarding Parallel Assessment
	John Groskoph, Pfizer, Peapack, NJ

	Industry Experience Regarding Consultative Advice Pathway
	Stephanie Krogmeier, Vertex, Cambridge, MA

	Panel Discussion
	All

Wednesday PM VI

Advanced Separations

Chair(s): John Crandall

	Fast and Micro Gas Chromatography – Recent Advances from the Winery to the Refinery to the Wellhead
	John Crandall, President – Falcon Analytical and Ned Roques, Chief Chromatography Officer – Falcon Analytical

	Improved Batch Process Throughput with Fast, Automated Food Grade Fatty Acid Endpoint Analysis
	Dr. Brian Rohrback, Infometrix, Inc., Jonathan Blackwell, Oleo Chemist, Process Improvement, Lonza, Inc.

	Fully Automated Fast & Micro Gas Chromatography for UltraFast Fuel Characterizations from C5 to C44: Significance & Performance Employing the New ASTM D-7798 Method
	Dr. Carl Rechsteiner, CRechsteiner Consulting, LLC, Presenter and Tom Bell, Quality Advisor, Petroleum Lab Consulting

	Environmental Assessments using Fast & Micro Gas Chromatography in the Transportable World
	Brian Rohrback – Infometrix, Inc

	Process Analytical Technology (PAT) Improving Efficiency and Workflows in the Laboratory
	Ernie Hillier, Waters Corporation, Milford, MA

	Recent Advances in Chromatography Data Systems Software: A More Complete Solution including Labs, At-Line, Online and Transportable
	George Schreiner, Vice President Technology, ChromPerfect

	Advanced Data Processing Requirements for Fast Chromatography: Automation, Automation, Automation
	Dr. Carl Rechsteiner, CRechsteiner Consulting, LLC and Brian Rohrback, President, Infometrix, Inc.

Wednesday PM VII

Process Raman

Chair(s): Brian Marquardt

	The 3R’s of Raman: Reliable, Repeatable, and Representative
	Ian R. Lewis, David Strachan, Maryann Cuellar, Pat Wiegand, Sean Gilliam, and Joe Slater, Kaiser Optical Systems, Inc., Ann Arbor, MI

	Single Platform Raman Methodologies for Automated Rapid Particle Identification and Content Uniformity Monitoring for Formulation Development and Control
	Eunah Lee, Jeff Bodycomb and Andrew Whitley, HORIBA, Scientific, USA and Adrian Knowles, Vincent Larat and Renata Lewandowska, HORIBA Scientific, France

	Application of Raman Spectroscopy for Real-Time Monitoring of Continuous Flow Reactors
	Brian J. Marquardt, Michael Roberto and Thomas I. Dearing, Applied Physics Laboratory, University of Washington, Seattle, WA

	H2S/Amine Analysis with AIT RPM View
	Zeb Vance, Applied Instrument Technologies, Upland, CA

	Method Development and Validation for Analysis of Pharmaceutical Tablets by Transmission Raman Spectroscopy
	Carl A. Anderson, Benoit Igne, James K. Drennen and Yi Li, Duquesne University, Pittsburgh, PA

	Ensuring Drug Quality and Safety with Long-Wavelength Portable Raman Spectrometry
	Mark Mabry and Claire Dentinger, Rigaku Raman Technologies

	Visualization and Process Understanding of Material Behavior in the Extrusion Barrel during a Hot-Melt Extrusion Process Using Raman Spectroscopy
	Thomas De Beer, * Lien Saerens,* Chris Vervaet,* Jean-Paul Remon,*Laboratory of Pharmaceutical Process Analytical Technology, Ghent University, Ghent, Belgium, Laboratory of Pharmaceutical Technology, Ghent University, Ghent, Belgium

	A Raman Spectroscopy Enabled Platform for Bioprocess Development
	Jessica Whelan, APC Ltd, Science Centre South, UCD, Belfield, Dublin, Ireland

	Raman BioPharmaceutical Application (TBA)
	Dawn Cohen, Amgen

Wednesday Evening

Special Session – Training the Next Generation: Process Analyzer Technicians

Chair(s): Scott Armstrong, ExxonMobil and J.D. Tate, Dow Chemical

	IFPAC Training Session
	Scott Armstrong – ExxonMobil and Dr. JD Tate – Dow Chemicals

Overview

The Petrochemical, Refining, Exploration, Semiconductor, Pharmaceutical and Aerospace industries are all facing a common crisis with regards to the lack of qualified Analyzer Technicians. The field of Process Analytics has grown exponentially in complexity and technical capability in the last 30 years. Manufacturer’s ability to measure part per billion levels of components in the process piping has never been better and the equipment that handles this complex analysis take skill and education to set up and maintain. The ability to measure more difficult components faster allows manufacturers to better control process, make more product with less energy, safer with fewer emissions. The training and development of the technicians needed to install and maintain this equipment has not kept pace with the quantity and complexity of the equipment being installed across a wide variety of industries. The IFPAC Training Counsel has undertaken the task of developing a White Paper for industry leaders that clearly outlines the issues associated with technician development.

	Goals
	Generate a White Paper outlining the issues with analyzer technician training and development including the lack of qualified technicians in industry at this time. Develop a group of industry experts representing multiple industries to identify the analyzer technician training needs going forward. Identify the KPI for success of the paper/effort. All Are Invited.

Thursday AM I

QbD- I – Implementation of QbD for Small Molecules

Chair(s): Lorenz Liesum and Sarah Pope Miksinki, ONDQA/FDA

	Application of Multivariate Analysis to Process Scale up Evaluation – Is the Parameter / Attribute Relationship Maintained from Lab to Plant?
	Christian Airiau, GlaxoSmithKline, King of Prussia, PA

	Imputation Methods for Predictive Monitoring and Model Predictive Control
	Chris McCready, UMETRICS INC., London, ON, Canada

	Design Space Estimation of the Roller Compaction Process
	Nabil Souihi, Mats Josefson, Pirjo Tajarobi, Bindhu Gururajan and Johan Trygg, Computational Life Science Cluster (CLiC), Department of Chemistry, Umea University, Sweden, Industrial Doctoral School, Umea University, Umea, Sweden Pharmaceutical Development, AstraZeneca R&D Moelndal, Sweden

	Robust Optimization – How to Find and Examine the Best Running Conditions Inside a Defined Design Space
	Conny Vikstroem, MKS Umetrics AB, Umea, Sweden

	Which Wavelength to Use? Building and Transferring Pharmaceutical Material Spectral Libraries Using Different Raman Excitation Wavelengths
	Jason D. Rodriguez, Yvette L. Loethen, John F. Kauffman, and Lucinda F. Buhse, FDA Division of Pharmaceutical Analysis, St. Louis, MO

	PAT-enabled Design Space Definition and Process Control for API Processes
	George Zhou, Merck

	PAT for Spraydrying Processes
	Hellings Mario, Johnson & Johnson, Antwerp, Belgium

	Early Readout of Degradation of Pharmaceutical Drug Substances and Formulations using Routine Electron Spin Resonance
	Dr. Michael Claybourn, Archipelago Technology Group Limited, Cambridge, UK

	Case Study Implementing PAT for API
	Olav Lynberg and Mark Johnson, J&J

Thursday AM II

BioTech – I – Real Time Monitoring of Bio-Reactors and Bio-Processing

Chair(s): Kurt Brorson and Michael Tarlov

	Bio-Reactors (TBA)
	Marina Hincapie, Genzyme

	An Integrated PAT Approach to Understand a Lab Scale Bioreactor Model IgG3 Cell Culture Process Media Dynamics
	Huiquan Wu, FDA, CDER, FDA, Silver Spring, MD

	Application of Design of Experiment as a PAT enabler for Upstream Mammalian Cell Culture
	Cyrus Agarabi, FDA, Silver Spring, MD

	Applying Characterization Tools Earlier in Bioprocess as part of Process Analytical Technology
	Michael Boyne, USFDA, Silver Spring, MD

	Model-based Control and Advanced Characterization of mAb Fed-Batch Cell Culture Processes
	Janssen: J. Cunningham, D. Davis, A. Fermier, A Harkins, J. Knighton, G. Leo, A. Lubiniecki, S. Mehrman, N. Migliore, E. Schaefer, D. Stauffer, K., Tomlin-Verni, J. Weber; ProSensus: M.J. Bruwer, J. MacGregor, I. Miletic; FDA: C.D. Agarabi, K. Brorson, E.K. Read and NIST: J. Schiel

	Utility of NIST mAb Reference Material for Method Qualification
	John Schiel, National Institute of Standards and Technology, Gaithersburg, MD

	Bio-Reactors (TBA)
	Bill Bentley, UMD

	Development, Optimization, and Scale-up of a 1,2,3-Triazole Synthesis in Batch and Continuous Flow; Lessons Learned from Advanced Online Analytics
	Charles Phoebe Jr., Waters Corporation, Milford, MA

	Exploring the Linkage Between Cell Culture and Downstream Processing via Statistical Design
	Erik K. Read, Brittany K. Chavez, Scott C. Lute, Kurt A. Brorson and Cyrus D. Agarabi, US Food & Drug Administration, Silver Spring, MD

	Intracellular Metabolic Flux Analysis of CHO Cells Supplemented with Wheat Hydrolysates for Improved mAb Production and Cell-Growth
	Yoon, Seongkyu, University of Massachusetts, Lowell, Department of Chemical Engineering, Lowell, MA

Thursday AM III

Risk Management Over Product Life Cycle – II

Chair(s): G. K. Raju & Daniel Peng, FDA

	Implementation of Risk-Based Review in Generic Drug Quality Assessment
	Andre Raw, FDA, Rockville, MD

	Risk Management as part of Analytical Quality by Design
	Rosario Lobrutto, Teva Pharmaceuticals, Pomona, NY

	QRM
	Alpesh Patel, Amneal Pharmaceutical, Hauppauge, NY

	QRM for PreApproval Inspection
	Mahesh Ramanadham, FDA, Silver Spring, MD

	Quality Risk Management in Generic Drug Products
	Siva Vaithiyalingam, Teva Pharmaceuticals

	QRM for Generics (TBA)
	Line Lundsberg, Lundsburg Consulting, Surrey, UK

	QRM (TBA)
	Kenneth Cote, Mylan Pharmaceuticals, Pittsburgh, PA

	Risk Management over Product Life Cycle – Panel Discussion
	G. K. Raju, Daniel Peng et al.

Thursday AM IV

Multivariate Model Validation in a Quality Environment: An International Consortium for Innovation and Quality in Pharmaceutical Development Session (IQ)

Chair(s): Doug Both and George L. Reid

The International Consortium on Innovation and Quality in Pharmaceutical Development (IQ Consortium) is an association of pharmaceutical and biotechnology companies aiming to advance innovation and quality in the development of pharmaceuticals through scientifically driven best practices and standards. The consortium seeks to contribute to the improvement of the safety and efficacy of pharmaceuticals for patient benefit. The consortium was formed in early 2010 with the goal of collectively addressing the scientific, technical, and regulatory challenges facing the development of both small- and large-molecule derived medicines. The advancement of global, science-based and scientifically driven standards and regulations is a key enabler towards achieving this goal.

	Risk Based Method Development and Validation for NIR Based Quantitative Methods of Formulated Pharmaceutical Products
	Gary McGeorge, Bristol-Myers Squibb, New Brunswick, NJ

	Scientific Discussion on Variable Selection
	Carl Anderson, Duquesne University, Pittsburgh, PA

	Use of Multivariate Techniques and Experimental Design for Development of Innovative Manufacturing Quality Systems
	Anna Persson, Umetrics, Wilmington, MA

	Equivalency Testing: The roles of Assay Precision, Truth, Bias, Tolerance, Risk and Control Strategy in Setting Equivalence Margins
	Kim E. Zerba, Sutan Wu1 and Gary McGeorge, Bristol-Myers Squibb, New Brunswick NJ, 1inVentiv Health Clinical, Lake Mary, FL

	The PAT Model Lifecycle: Experience with Validation and On-going Verification
	John Higgins, Charles E. Miller, Nathan Pixley, Manoharan Ramasamy, and Niya Bowers, Merck, West Point, PA

	Validation of Multivariate Models with a Focus on Chemometric NIR Models
	Bogdan Kurtyka, FDA, Silver Spring, MD

	USP Spectral Library – Development Validation and Implementation
	Michael A. Dotlich, Eli Lilly and Company

	Validation and Application of Multivariate Models in the Context of Process Monitoring and Continuous Process Verification(CPV)
	Lorenz Liesum, Novartis Pharma, Basel, Switzerland

Thursday AM V

Process Monitoring & Control – I – Process Automation/Intelligence Based Manufacturing (IbM)

Chair(s): Mojgan Moshgbar, Ke Hong and Tahseen Mirza, FDA

	The IFPAC 2014 Intelligent Biopharmaceutical Manufacturing (IbM) session will examine the disruptive opportunities offered by predictive and adaptive technologies in all stages of a patient-centric product life cycle; from basic research and development to product transfer and commercialization.

	IbM Vision and Opportunities in Pharmaceutical Industry
	Alton Johnson, Ph.D, Vice President, Technology and Business Solutions, PGS, Pfizer

	Agent-based Modeling of Angiogenesis and Scaffold based Tissue Growth
	Hamidreza Mehdizadeh, Ph.D., AMT, GTS, Pfizer

	Nano Particle Enhanced Multi-Mode Raman Spectroscopy Solution Offers Expanded Range of Measurements in Support of Intelligence Based Manufacturing
	Rudy Hofmeister, H2Optx Inc., San Jose, CA

	Application of Hyperspectral Imaging in late Stage Pharmaceutical Development
	Gabor Kemeny, Ph.D., CEO, Middleton Research

	Smart PATs for Adaptive Control of Flexible Pharmaceutical Systems
	Ke Hong, Ph.D., TBS, GTS, Pfizer

	Model-based Supervision and Control of Biological Systems – Tissue Engineering and Artificial Pancreas
	Ali Cinar, Illinois Institute of Technology, Chicago, IL

	IbM Wrap- up Discussion – All

Thursday AM VI

Chemometrics (COPA) – I

Chair(s): Brian Rohrback and Juergen von Frese

Chemometrics has been around as a field since the early 1970s and came into routine use in the early 1990s. There is still a gap, however, between the level of effort that has been aimed at R&D and what has been implemented for process applications. To help close this gap, CPAC formed an initiative called COPA (Chemometrics for On-line Process Analytics) which relies on the IFPAC meeting as a means of communicating new approaches to use of multivariate methods for on-line and near-line quality assessments and process control. The session raises issues and combines input from analytical instrument manufacturers, software purveyors, academia and end-use industry to stimulate discussion of the field and how to best take advantage of chemometrics technology in a profitable way.

	Optimally Dividing Available Samples into Calibration and Validation Sets for FT-IR Based Multivariate Models
	James M. Brown(1) and Bryan T. Bowie(2), 1-Applied Instrument Technologies, Inc. 2-ExxonMobil Research & Engineering Co., Applied Instrument Technologies, Inc., Flemington, NJ

	Mixed Hierarchical Models for the Process Environment
	Barry M. Wise, Robert T. Roginski, Neal B. Gallahger and Jeremy M. Shaver, Eigenvector Research, Inc.

	Challenges of Chemometrics for Handheld Instrumentation
	Katherine A. Bakeev and Dawn Yang, B&W Tek

	Tricks of the Trade for gathering Production Intelligence from Historic Process Data
	Juergen von Frese, Data Analysis Solutions DA-SOL GmbH, Utting am Ammersee, Germany

	OPLS in Batch Monitoring Opens New Opportunities
	Johan Trygg, Umea University, Chemistry Department, Computational Life Science Cluster (CliC), Umea, Sweden

	Simple Chemometrics Application for Complex Development Issues – Criticality of the Pre-processing Step
	Christian Airiau, GlaxoSmithKline, King of Prussia, PA

	Managing Uncertainty in Design Space
	Mark Anderson, Stat-Ease, Inc., Minneapolis, MN

	Open Discussion – All

Thursday AM VII

Advanced Instruments Concepts

Chair(s): Fred Baudais, Jason Dickens and Troy Francisco

	Working with Challenging Samples, Sampling Systems
	Yves Gamache, Norgren AFP, Thetford Mines, Canada

	Real-time, FAIMS-based Chemical Detection Systems that Change the Way business is done in the lab…at the Loading Dock…and on the Plant Floor
	Steven Freshman, Owlstone Inc, Norwlak, CT

	Bus Integration and Automated Calibration Record Retrieval
	Matt MacConnell, PE, Air Products and Chemicals, Global Engineering Analyzer Systems Technology Manager

	A Tunable Diode Laser Gas Aanalyzer for On-line Measurements of Acetylene in Ethylene Production
	Airat Amerov, Mike Fuller, AMETEK Process Instruments, Pittsburgh, PA and John Orendorff, LyondellBasell CCO Plant, Corpus Christi, TX

	Application of Data Fusion in Single Analyzer with Combined UV and IR Spectroscopy for Sulfur Recovery Process Control
	Tony Myles, Mike Fuller and Honggang Li, Ametek Inc., Pittsburgh, PA

	Fiber Probes and Sensors for Process Spectroscopy
	V. Artyushenko and J. Mannhardt, art photonics GmbH, Berlin, Germany

	Monitoring Asphaltene in Crude Oil
	Mike Ponstingl, Custom Sensors & Technology, Fenton, MO

	Process Analytical Technology and Chemometrics Application to Plastics: Benefits and Challenges
	Yusuf Sulub, SABIC, Mt Vernon, IN

	A PAT-based Experimental Methodology Relating Velocity Profiles in Flowing Powder Mixtures with Cohesion/adhesion Parameters
	Nicolas Abatzoglou (), Oumaima Chaib and Ryan Gosselin, () Corresponding author, Universite de Sherbrooke, Department of Chemical & Biotechnological Engineering, Pfizer Chair, Sherbrooke (Quebec), CANADA

	Novel Laser-based Instrumentation for Continuous Real-time Measurements of Trace Gases and Isotopes
	Douglas Baer, Los Gatos Research, Mountain View, CA

Thursday AM

Food Quality, Safety & Analysis Symposium: Emerging Technologies with Focus on Traceability and Contamination

Chair(s): Carol Zrybko, Ph.D., Mondelez International, East Hanover, NJ and Michael McCarthy, Ph.D., University of California Davis, Davis, CA

Food safety incidents have reduced consumer confidence in the food industry and supply chain prompting increased government intervention and regulation on food safety and food defense. Rapid analysis methods – particularly in the area of microbial and chemical threat agent detection – are being developed at an ever accelerating pace. This session will focus on emerging technologies in analytical/detection methods, rapid bio-monitoring and genetic fingerprinting in a response to recent contamination issues.

	FT-NIR Technology for process control in the Food industry
	Florian Eigenmann, Bruker Optics Inc., The Woodlands, Houston TX

	A-scan Guided Microwave Spectrometry for In-line Measurements of Tomato Concentrate Properties
	Michelle Schultz and Rick Cash, Thermo Fisher Scientific, Minneapolis, MN

	Feasibility of Multipoint NIR Spectroscopy to Characterise Powder and Granule Blends
	Carl Sullivan, Dublin Institute of Technology, Dublin, Ireland

	Optimize Your Dairy Production by Utilizing Inline High Resolution Near Infrared Spectroscopy and Real Time Control
	Jeff Boedigheimer, Foss North America

	Food Analysis to Check Quality, Safety and Authenticity by Full-automated NMR
	Markus Link, Bruker BioSpin GmbH, Baden-Wuerttemberg, Germany

	Application of IR Chemical Imaging and DNA Microarrays to the Identification of Fish Species
	M.M. Mossoba, S.M. Handy, V. Chizhikov, S. Paul, B.J. Yakes and J. Deeds, FDA, CFSAN, ORS, College Park, MD

	Melamine Gone Stealth: Impact of Sample Preparation on NIR Detection of Melamine in Skim Milk Powder Matrix
	Jeffrey C. Moore and Lucy Botros, U.S. Pharmacopeial Convention, Rockville, MD

	Infrared Spectroscopy for Food Fingerprinting: Opportunities and Challenges
	Steve Holroyd, Fonterra, Fonterra Research and Development Centre, Palmerston North, New Zealand

Thursday PM I

QbD – II – Implementation of QbD for Complex Dosage Forms

Chair(s): Sharmista Chatterjee, FDA, and Theodora Kourti, GSK

	Regulatory Perspectives on Implementation of QbD for MDIs and DPIs
	Prasad Peri, FDA, Silver Spring, MD

	Ellipta Inhaler – Design Development & QbD
	Richard Walker, GSK

	Real World Application of QbD Principals to the Development of Dry Powder Inhaled Products
	Mark Whitaker, GSK

	Regulatory Perspective on QbD for Topicals
	Office of Generic Drugs, FDA (TBA)

	Assuring Drug Product Quality and Patient Safety through the Application of QbD to Packaging and Delivery Systems
	Diane M. Paskiet, West Pharmceutical Services, Exton, PA

	QbD Implementation for Manufacture of Drug Eluting Stents
	FDA (TBA)

	Real Time Release Testing of Ciprofloxacin HCl Modified Release Capsules. Case Study
	Raafat Fahmy, PhD., The Food and Drug Administration, Center for Veterinary Medicine, Rockville, MD

	Case Study for QbD Scale-Up for a Nasal Suspension
	Wan Jiang, APOTEX

	Open Discussion – All

Thursday PM II

BioTech – II – MSAT in Biologics Manufacturing

Chair(s): Ranjit R. Deshmukh and Jose C. Menezes

	MSAT Strategies for Business Process Excellence in Pharma & BioPharma: QbD 2.0
	Jose C. Menezes, Pedro F. Felizardo and Joao E. Machado, 4Tune Engineering Ltd., Lisbon, Portugal

	PAT and Process Control in a Small Scale Environment
	Barbara Kavsek, Siemens, Vienna, Austria

	Inline Biomass Measurement in Cell Cultivation
	Jochen Scholz, Henry Weichert and Gerhard Greller , Sartorius Stedim Biotech GmbH, Goettingen, Germany

	Data Management and Control Strategies for Continuous BioProduction
	Kjell Francois, Siemens, Brussels, Belgium

	Implementing End-to-End Process Analysis over Life-Cycle with iSEET
	Pedro Felizardo, Joana Mendes, Tiago Robalo, Stefan Buziol and Christine Jung, 4Tune Engineering Ltd, Lisbon, Portugal; Roche Diagnostics GmbH, Pharma Biotech Development, Penzberg, Germany

	Open Discussion – All

Thursday PM III

Lifecycle Management of Analyzer and Method Robustness

Chair(s): Gert Thurau and Martin Warman

2014 Theme: Lifecycle management of PAT models

This session traditionally covers all aspects of system robustness for PAT methods, with a particular focus in 2014 on model robustness and management of changes to chemometric models. The development of robust correlation models and the management of these models over time has a long history in the discipline of multivariate and other correlation methods. Concepts of robustness design, model verification including use of multivariate outlier detection and model updates are routine work processes in most industries employing multivariate correlative models. In the pharmaceutical industry with only about a decade of use of these models in production scientific and business aspects are intertwined with regulatory considerations for the ongoing change management of models. This session will explore the topic from various angles.

	A Multivariate Calibration Model Maintenance Road Map (TBA)
	Barry Wise, Eigenvector

	Lifecycle Management: Method Robustness
	Manoharan Ramasamy, Merck, West Point, PA

	Addressing Lifecycle Management Aspects of Empirical Models
	Brad Swarbrick, CAMO Software Inc., Woodbridge, NJ

	Process Analyzer Continuous Verification
	Jason E. Dickens, GlaxoSmithKline, Durham, NC

	Why Models are Indispensable
	Juergen von Frese, Data Analysis Solutions DA-SOL GmbH, Utting, Germany

	How to verify NIR method suitability using Transfer Function Standardization developed from a series of Transmission, Reflectance, and Wavelength Standards
	Timothy Stevens, John Bobiak, Dimuthu Jayawickrama, Bristol-Myers Squibb, New Brunswick, NJ

	Open Discussion – All

Thursday PM IV

Using Process Capability to Ensure Pharmaceutical product Quality – Industry and Regulatory Perspective (Brand and Generics)

Chair(s): Lawrence Yu, FDA and Daniel Peng, FDA

	Clinical Relevant Specifications (TBA)
	Rik Lostritto, FDA

	Use Process Capability to Ensure Pharmaceutical Product Quality (TBA)
	Daniel Peng, FDA

	Industry Case Study (TBA)
	Jean-Marie Geoffrey, Hospira

	Industry Case Study (TBA)
	Alpesh Patel, Amneal

	Industry Case Study (TBA)
	Michael Choi, Particle Coating Technology Solutions (PCTS)

	Panel Discussion – All

Thursday PM V

Process Monitoring & Control – II – PAT Implementation for Drug Product Development & Manufacturing

Chair(s): Tim Stevens and Gawayne Mahboubian-Jones

	Learning from PAT-based Analytical Control to Engineering Control: A Case Study on Roller Compaction of a Spray-dried Dispersion Based Formulation
	Pete Shi, Eli Lilly

	Platform Technologies for Manufacturing Process Optimization through Integration of PAT and Control System
	Jun Huang, Pfizer, Inc., Peapack, NJ

	Suitability of Lab-scale NIR Calibration Models for Monitoring In-Process Powder Blends in a Continuous Manufacturing Process
	Yleana Colon, Janssen Supply Chain, Gurabo, Puerto Rico

	Implementation of a NIR, At-line Automated Tablet NIR System for Same Day Analysis of Continuously-Made Drug Product
	Greg Doddridge, Lilly

	Real Time Process Control and Continuous Product Characterisation using Transmission NIR in Continuous Pharmaceutical Manufacturing
	Mikko Juuti1, Jarkko Ketolainen2, Simo-Pekka Simonaho2, Maunu Toiviainen1 and Guy Newcombe3, 1VTT Technical Research Centre of Finland, 2University of Eastern Finland and 3Archipelago Technology Group Ltd

	Case Study for Justifying and Implementing PAT in a Solid Dose Pharmaceutical Facility
	Michalle Adkins, Emerson, Royersford, PA

	Business Appropriate PAT Applications from Development to Marketed Aseptic Drug Products
	Bradley Diehl, Robert M. Leasure, and Mark R. Smith, Pfizer, Inc., Peapack, NJ

	Lifecycle of a Kinetics-Based Reaction IPC during API Process Development
	Jeffrey Nye and Bob Wethman, Bristol-Myers Squibb, New Brunswick, NJ

	Distillation Monitoring with NIR Spectroscopy – From Laboratory Experiments to Manufacturing
	Dr. Christian Lautz, F. Hoffmann-La Roche Ltd, Basel, Switzerland

Thursday PM VI

NeSSI

Chair(s): Mel Koch

	Introduction to NeSSI
	Mel Koch, APL, University of Washington, Seattle, WA

	NeSSI for Bio-Processing (TBA)
	Brian Marquardt, CPAC, APL, University of Washington, Seattle, WA

	Advances in Mini GC (TBA)
	John Crandall, Falcon Analytical and Brian Rohrback, Infometrix, Inc., Bothell, WA

	The picoSpin80 NMR Spectrometer: A Robust, High Performance NMR Sensor for the Process Environment
	John Frost Ph.D., Chemist, NMR Technology Group, Thermo Fisher Scientific, Boulder, CO

	Process Analytics: Aiding and Abetting via NeSSI
	Michael Hoffman, Siemens, Montgomery, TX

	NeSSI Application (TBA)
	Anders Martinsson, ABB

	NeSSI Application (TBA)
	Marcus Trygstad or David Novak, Yokogawa

	Online Process Control using Modular Fluid Delivery and Fast & Micro Process Gas Chromatography: From the Sample Point to the DCS Connection
	John Crandall, President – Falcon Analytical and Ned Roques, Chief Chromatography Officer – Falcon Analytical

	Integration of Continuous Flow Reactors, NeSSI, and PAT for Process Understanding
	Michael F. Roberto, Thomas I. Dearing and Brian J. Marquardt, UW, APL CPAC

	Evolving Applications that Demonstrate the Versatility of the NeSSI Platform
	Mike Cost, Parker, Huntsville, AL

Thursday PM VII

Imaging

Chair(s): Steve Hammond and Carl Anderson

	Novel Near-Infrared Hyperspectral Imaging Approach for Food and Pharmaceutical Screening Applications
	Howland D. T. Jones, Lam K. Nguyen and Eli Margalith, OPOTEK, Carlsbad, CA

	Airborne Ultrasound: The Next Wave in Process Analytical Technologies
	Oliver Stauffer, Packaging Technologies & Inspection, Tuckahoe, NY

	Near Infrared Hyper-spectral Imaging for Controlling the Quality of Large Scale Transdermal Drug Manufacturing
	James K. Drennen, Carl A. Anderson and Benoit Igne, Duquesne University, Pittsburgh, PA

	Multiplexed Imaging Spectrometer Instrument for PAT
	Rudy Hofmeister, H2Optx Inc., San Jose, CA

	Thermal Imaging in Pharmaceutical Manufacturing Processes Monitoring
	Fabian Schapiro, DIR Technologies, Haifa, Israel

	Open Discussion – All

Thursday PM VIII

Process Spectroscopy

Chair(s): John Coates, Bob Bear and George Vickers

	Determining the Mineral Content of Pharmaceutical Multivitamin Tablets using LIBS
	Philip Quinn1, 2, Ryan Gosselin1,(), Nicolas Abatzoglou1,(), Joanny Salvas2 and Jean-Sebastien Simard2, 1. Department of Chemical & Biotechnological Engineering, Faculty of Engineering, Universite de Sherbrooke, Sherbrooke, Quebec, Canada, 2. Process Analytical Sciences Group, Pfizer Canada Inc, Saint-Laurent, Quebec, Canada

	Experimental and Computational Techniques for Overcoming the Challenges of Quantitative Crystallinity Measurements Using Terahertz Spectroscopy
	Mark Sullivan, Edward King, David Heaps, Xiao Hua Zhou, Richard McKay and Wiphusanee Dendamrongvit, Advantest America, Inc., Princeton, NJ

	New Small Spectrometer Concepts Covering the Ultraviolet to the Mid-Infrared
	John Coates, Coates Consulting LLC, Newtown, CT

	Near Infrared Based PAT Continues its way into Solid Dose Production
	Uwe Kirschner, Managing Director Sentronic GmbH, Germany, Sebastian Sowinski, Key Account Manager Sentronic GmbH, Germany and Phil Doherty, Managing Director, Process Analytics Ltd., Ireland

	Applying Terahertz Technology for Nondestructive Detection of Crack Initiation in a Film-coated Layer on a Swelling Tablet
	Wataru Momose, Astellas Pharma Inc. / Duquesne University, Pittsburgh, PA

	CO Monitoring of Coal Silos using an Insitu TDL
	Warren Dean, Siemens Industry, Inc., Bartlesville, OK

	100% Residual Moisture and Lyo-cake Defects Inspection by VisioNIR
	Sven Borchert, Visiotec GmbH, Laupheim, Germany

Thursday PM

Food Quality, Safety & Analysis Symposium: Food Safety

Chair(s): Luis E. Rodriguez-Saona, Ph.D., The Ohio State University, Columbus, OH and Bei Ma, M.S., United States Pharmacopeial Convention, Rockville, MD

Food pathogens create an enormous social and economic burden on communities and health systems continuing to be a source of concern for consumers, federal government, and industry. The US Government has identified a number of previously unrecognized food vehicles as causes of foodborne disease, and the development of control strategies for pathogens and contaminants need to address a wide range of foods. This session will focus on detection technologies for foodborne pathogens addressing sensitivity, specificity, speed of testing, and use under a variety of conditions to ensure safe foods.

	Quantitative Allergen Risk Assessment
	Simon Flanagan, Senior Consultant-Food Safety & Allergens, Reading Scientific Services, Ltd. (RSSL), UK

	Novel Spectroscopic In-line Methods used for Process Control of Foods
	Jens Petter Wold, Nofima (The Norwegian Food Research Institute), As, Norway

	Application of Portable FT-IR Spectroscopy to Detect Chemical Contaminants
	Luis E. Rodriguez-Saona, The Ohio State University, 110 Parker Food Science and Technology, Columbus, OH

	Rapid Identification of Microbial Contaminants in Bulk Commodities and Food Storage Environments
	Andrew P. Bartko, Ph.D., Technology Development Group, Battelle Memorial Institute, Columbus, Ohio

	Combating Adulteration of Foods and Dietary Supplements through Quality Standards – A USP Solution
	Bei Ma, M.S., United States Pharmacopeial Convention, Rockville, MD

	Strategies and Practice against Food Adulteration in China
	Jing Zhang & Bing Shao, Beijing Center for Disease Prevention and Control, Beijing, China

	Open Discussion – All

Thursday Evening

Food Quality, Safety & Analysis Symposium

Chair(s):

	Open Evening…Get together for the Food Symposium Dinner…dinner on your own

Friday AM I

QbD III – Implementation of QbD for Analytical Methods

Chair(s): Sonja Sekulic and John Kauffman, FDA

	This session will define the scope of the FDA/EMA program on Analytical QbD. This will include Robust Analytical Method Development by QbD Principles, Content Uniformity and RTRT. The updates on CU Guidance will be reviewed

	Opening Remarks
	Sonja Sekulic, Pfizer

	Application of Analytical Method QbD within GSK
	Phil Borman, GSK

	FDA-EMA Collaborative Research on Analytical Method QbD: Project Status
	John Kauffman, FDA, St. Louis, MO

	Examples of Application of QbD Principles to Analytical Procedures
	Kimber Barnett, Pfizer

	Progressing Towards Operational Flexibility in Analytical Procedures – Global Change Control and Regulatory Expectations
	Joerg Hoffman, EFPIA/Merck EU

	QbD Approach and Analytical Procedures
	Yubing Tang, FDA, Silver Spring, MD

	Developing an Analytical Impurity Control Strategy Using QbD
	Mark Argentine, Lilly

	Application of Analytical QbD to Robust Chromatographic Method Development and Technology Transfer
	Russell Hertzler, AbbVie

	Roundtable Q & A – All

Friday AM II

Bio-Tech – III – Bio-Processing/Bio-Transformations

Chair(s): Antonio Moreira and John Higgins

	This session will discuss and provide examples of applications of process analytical technologies to a variety of bioprocessing production systems, including biologics and small molecule manufacturing.

	NIR-Spectroscopy for Bioprocess Monitoring & Control
	Dan Kopec, Sartorius Stedim North America, Bohemia NY

	Multipoint Spatially Resolved Spectroscopy for Tablet and Biotech Application: Real Time Monitoring of Critical Physical and Chemical Attributes
	Boris Larcheveque, INDATECH, Prades le Lez, France

	Implementation of Real-Time MVDA as a Platform PAT Tool for Vaccines and Biologics
	John Higgins, Louis Obando, Charles Miller and Niya Bowers, Merck, West Point, PA

	An Automated Bioreactor Sampling Solution for Assuring On-line PAT Analytical Fidelity
	William Miller, Lucas Schimmelpfenning and Michael Biksacky, Flownamics, Inc., Madison, WI

	Pharmaceutical Quality control of Complex Botanicals
	Dr. Peter Gibson, Technical Director, GW Pharmaceuticals, UK

	Open Discussion – All

Friday AM III

QbD in CMO/CRO

Chair(s): Manoharan Ramasamy

	Implementation and Long-Term Maintenance of a QbD Drug Product at a CMO
	Ivelisse Colon-Rivera and Joseph Medendorp, Vertex Pharmaceutical, Cambridge, MA

	Creating Value in the Supply Chain: A perspective from a CMO
	Nuno Matos, Hovione, Loures, Portugal

	Interpreting Cell Culture Behavior and Predicting Process Performance with the use of PAT Tools and Modeling Methods
	Jim Mullin and Brandon Downey, Bend Research Inc., Bend, OR

	PAT Implementation in a Continuous Process – Challenges and Opportunities from the System Provider Point of View
	Tomas Vermeire & Richard Steiner, GEA Pharma Systems, Wommelgem, Belgium

	Case Study: Using QbD Principles to Achieve Continuous Process Improvement
	Kristin Arnold, Norwich Pharmaceuticals, Norwich, NY

	QbD in CMO/CRO Applications (TBA)
	Joep Timmermans, Pfizer, Peapack, NJ

	Panel Discussion: QbD in CMO/CRO
	Mark A. LaPack, Eli Lilly (Moderator) and Manoharan Ramasamy, Merck

Friday AM IV

QbD and PAT in the Generic Industry

Chair(s): Daniel Peng, FDA and Inna Ben-Anat

	Room Set Up and Introductions
	Daniel Peng, FDA

	QbD Implementation in Generics: are we there yet? Industry Perspective
	Inna Ben-Anat, Teva Pharmaceuticals

	A QbD Approach to the Development of a Generic Transdermal or Topical Product
	Mike Fowler, Actavis

	Scaling up QbD – Case Studies
	Tamar Ben-Avi, Taro Pharmaceuticals

	How to PAT in Generics – Case Studies
	Marta Lichtig, Taro Pharmaceuticals

	The use of Thermal Imaging for PAT Applications in Packaging
	Eran Sinbar, DIR

	PAT in ANDA Applications
	Geoffrey Wu, FDA

	OGD Update and Observations in QbD Submissions
	Jennifer Maguire/Daniel Peng, FDA

	Q & A
	All speakers

Friday AM V

PAT Links to Post-Approval Manufacturing (PV and CPV)

Chair(s): Ranjit Deshmukh, Tara Gooen, FDA and Vibhakar Shah, FDA

	This session will outline FDA and Industry perspectives covering the important topics of Process Validation (PV) and Continuous Process Verification (CPV).

	Check on our web pages for updates on this session www.IFPACPAT.ORG

Friday AM VI

Chemometrics (COPA) – II

Chair(s): Brian Rohrback and Juergen von Frese

	35 Years of Chemometrics
	Brian G. Rohrback, Ph. D., Infometrix, Inc., Bothell, WA

	PAT, QbD and MVA Modeling in Pharmaceutical Development of the 21st Century
	Weiyong Li, NIRACLE LLC, Newtown, PA

	Using Model Fusion for Calibration Updates
	Marc Trygstad, Yokogawa

	Variable Selection Techniques for Model Validation of Quantitative Raman Spectroscopy
	Carl A. Anderson, Benoit Igne, James K. Drennen and Yi Li, Duquesne University, Pittsburgh, PA

	Fulfilling the COPA Vision – Turnkey On-line Process Analysis
	W. Michael Doyle and Michael A. Power, Symbion Systems, Inc., Brad Swarbrick, CAMO Software AS, Richard Kramer, Applied Chemometrics, Inc.

	Data Fusion with Simple Sensors
	Nelson Lytle, UOP, Des Plaines, IL

	A New Window into Process Data- Descriptive Data Analysis of Multi-block Data
	Ing-Marie Lindstroem, MKS Umetrics, Malmoe, Sweden

	Discussion/COPA Wrap-up – All

Friday AM VII

Particle Characterization

Chair(s): Nuno Matos and Ewa Marszal, FDA

	Novel Application of Dynamic Light Scattering as PAT for On-line Nano-particle Characterization
	Alon Vaisman, Malvern Instruments, Westborough, MA

	Online Particle Size in Continuous Manufacturing
	Justin Pritchard, Vertex, Cambridge, MA

	Protein-like Sub-visible Particles Standard: Round Robin Comparison (TBA)
	Dean Ripple, NIST, Gaithersburg, MD

	An PAT-based Experimental Methodology Relating Velocity Profiles in Flowing Powder Processes with Cohesion/adhesion Parameters
	Nicolas Abatzoglou(), Oumaima Chaib and Ryan Gosselin, () Corresponding author Universite de Sherbrooke, Department of Chemical & Biotechnological Engineering, Pfizer Chair, Sherbrooke (Quebec), CANADA

	Primary Container, Formulation and Temperature Dependent Formation and Morphology of mAb Particles
	Stephen Brych, Amgen

	PAT for Particle Size and Zeta Potential On-line Measurement using Ultrasound
	Andrei Dukhin and Sean Parlia, Dispersion Technology Inc, Bedford Hills, NY

	Open Discussion – All

Friday AM

Next Stage of QbD Implementation (An ISPE Session)

Chair(s): Stephen Tyler, AbbVie and Theodora Kourti, GSK

	A series of presentations will include Quality Metrics, Process Validation and Breakthrough Therapies, plus an ICH Q7 question and answer update.

	Quality Metrics
	Cindy Salamon, Bristol Myers-Squibb (double time slot)

	Statistical Approaches for PPQ: Options and Outcomes
	Tara Scherder, Arlenda

	Application of the Process Validation Lifecycle to Biotech Products
	Dave Dolgin, Abbvie, Waukegan, IL

	Continued Process Verification for Biotech Process (TBD)
	Ranjit Deshmukh (TBC), Medimmune

	Breakthrough Therapy Designation: Small Molecule Considerations
	John Groskoph, Pfizer, Peapack, NJ

	Risk Benefit Considerations in Accelerated CMC/GMP Development and Launch of Breakthrough Therapy Products
	Earl Dye, Genentech

	ICH Q7: GMP for API – why is ICH Developing Q&A now?
	Betsy Fritschel, Johnson and Johnson

Friday AM

Handheld/Screening – A Joint Session with OnSite Analysis

Chair(s): Paul DeRose and Paul Vahey

	Anti-Counterfeit Screening of Finished Drug Products Using Handheld Spectrometers
	Yvette Loethen, FDA Division of Pharmaceutical Analysis, St. Louis, MO

	SPME Sampling for Nerve Agent Exposure in Urine
	Rodney Hudson, QuickSilver Analytics, Inc., Belcamp, MD

	Long-Wavelength, Hand-Held Raman Spectrometer for Pharmaceutical Material Identification
	Mark Mabry and Claire Dentinger, Rigaku Raman Technologies

	Vibrational Spectroscopy in the Field
	Luisa Profeta, MRIGlobal, Kansas City, MO

	Real-time Tablet API Analysis: A Comparison of a Palm-size NIR Spectrometer to HPLC Method
	Chris Pederson, JDS Uniphase, Santa Rosa, CA

	A Review of New Small-Scale Technologies for Near Infrared Measurements
	John Coates, Coates Consulting LLC, Newtown, CT

	MicroNIR(TM): Evaluating a Handheld Near-Infrared (NIR) Spectrometer for Raw Material Identification
	Gary E. Ritchie1*, Sharon Flank1, Nada O’Brien2, Chris Pederson2, Don Friedrich2 1InfraTrac: Silver Spring Innovation Center, Silver Spring, MD, 2JDSU: Optical Security and Performance Products, Santa Rosa, CA

	Chemometrics Applied to Complex Biological Systems using Ion Mobility Mass Spectrometry: Unsupervised and Supervised Methods
	Kimberly Kaplan-Sandquist, FBI, Quantico, VA

Friday AM

Food Quality, Safety & Analysis Symposium: PAT for the Dairy Industry

Chair(s): Colm O’Donnell, Ph.D., University College, UCD-Dublin Institute of Food & Health, Dublin, Ireland and Steve Holroyd, Ph.D., Fonterra Research Centre, New Zealand

	Application techniques, case studies, and the benefits of Implementing PAT for the dairy industry and in infant formula will be presented. Traditional dairy and pharmaceutical approaches and technologies will be discussed, also taking into consideration the nutritional arena.

	Process Analytical Technology Application for Real Time Quality Monitoring during Milk Powder Production
	Nicholas Depree, I.Boiarkina, V. Rimpilainen, A.Prince-Pike, B.Young and D.Wilson, University of Auckland, Auckland, New Zealand

	Who’s to blame? Relating Input Disturbances to Output Variations in Milk Powder Fortification
	Ville Rimpilainen, Irina Boiarkina, N. Depree, W. Yu and D.I. Wilson, University of Auckland, Department of Chemical and Materials Engineering, Auckland, New Zealand

	Fluorescence Sensor for Process Control in the Dairy Industry
	Fred Payne, University of Kentucky, Lexington, KY

	Fluorescence for Monitoring Yogurt Fermentation and Predicting Culture Endpoint
	Timothy Mains, University of Kentucky, Lexington, KY

	Detecting the Presence/Absence of Inclusions in Ice Cream using Guided Microwave Spectrometry
	Michelle Schultz, Thermo Fisher Scientific, Minneapolis, MN

	Application of a Fluorescence Sensor to Monitor Rheological Changes in Milk during Enzymatic Coagulation
	Colette Catherine Fagan, University of Reading, Reading, UK

	Open Discussion – All

Friday PM I

QbD – IV: Implementation of Question based Review (QbR) for Generic & Brand Industries

Chair(s): Sharmista Chatterjee, FDA

A question-based review (QbR) format or the Chemistry, Manufacturing, and Controls (CMC) evaluation of Abbreviated New Drug Applications (ANDAs) was implemented in 2006 by FDAs Office of Generic Drugs. QbR provides a structured framework for documentation of information in the submission that adheres to the ICH CTD format. Objective of adoption of the QbR format is to enhance quality, effectiveness, and focus of regulatory assessment. Currently, FDA is engaged in revising the QbR template to facilitate a patient centric risk based review and is also exploring implementation of the QbR approach for review of new drug applications. In this session participants from FDA will give an update about the current status of the QbR program. This will be followed by Industry perspectives and a Panel Discussion.

A series of Short Talks Upfront to Set the Stage for Ensuing Discussions – Plan on staying for this must attend session, anchoring IFPAC-2014 week.

	The QbR Vision
	Ramesh Sood, FDA, Silver Spring, MD

	QbR Examples for Drug Substance
	Barbara Scott, FDA, Silver Spring, MD

	QbR Examples for Drug Product
	Jennifer Maguire, FDA, Silver Spring, MD

	Industry Perspective on QbR Question as it Relates to ANDA Review
	Kiran Krishnan, Vice President US Regulatory Affairs, APOTEX

	….additional Industry Perspectives…..

	Ensuing Discussions – All
	All

Friday PM II

Bio-Tech IV – Process Control for Biotechnology/Pharmaceutical

Chair(s): Cenk Undey and Jose C. Menezes

	Enabling Automation and Optimization Technologies for Robust Process Development
	Andree Ellert, Sartorius Stedim Biotech GmbH, Goettingen, Germany

	Model Predictive Monitoring and Control for Cell Culture Bioreactor Operations
	Tony Wang, Amgen

	Integration of Dielectric Spectroscopy with other Spectroscopies to Enhance Monitoring and Control of Mammalian Cell Cultivations
	Pedro Felizardo, Joana Mendes, Francisca Folque, Stefan Buziol, Mark Roth, Christine Jung and Jose Menezes, 4Tune Engineering Ltd, Lisbon, Portugal; Roche Diagnostics GmbH, Pharma Biotech Development, Penzberg, Germany

	Implementation of Capacitance Probes for Continuous Viable Cell Density Measurements for Manufacturing Processes at Biogen Idec
	Jason Wong, MS (Speaker), Jeff Simeone and Mark Byers, BIOGEN, Idec

	Control Loops for Glucose Feed in Cell Culture and Microbial Fermentation Bioprocesses Based on Online Measurement
	Henry Weichert , Mario Becker, Sartorius Stedim Biotech GmbH, Goettingen, Germany*

	A Generic Platform Technology for Monitoring and Feedback Control of Nutrients and Metabolites in Biopharmaceutical Processes
	Hamidreza Mehdizadeh, Ph.D., and David Lauri Pla, Ph.D., Pfizer

	Kaiser Raman coupled with Umetrics SIMCA Yields Continuous, in situ Measurement and Control of Bioprocesses in Real Time
	(TBA), Kaiser Optical

	Advanced Control of Batch and Continuous Pharmaceutical Crystallization Processes
	Zoltan K Nagy, Purdue University

Friday PM III

Lifecycle Control and QA

Chair(s): Rick Friedman, FDA and Ravi Tejwani

	This session will cover novel approaches to blend uniformity, dissolution and imparities, to overall improve statistical Process Control Opportunities.

	Better Statistical Process Control Opportunities – This presentation will address the important role of SPC in detecting variation, ensuring stable processes, and identifying process improvement opportunities
	Alex Viehmann and Karthik Iyer, FDA, Silver Spring, MD

	Relating blend uniformity specification to finished product assay, dissolution, and its biorelevance – This presentation will address the link between in vitro drug product tests and the potential for impact on in-vivo performance of the drug product
	Ravi Tejwani, BMS

	Some Recent Findings of Product and Process Understanding at CDER – Recent insights gained through CDER’s pharmaceutical science research work will be presented. This includes discussion of notable findings that illuminate how processes directly influence finished product quality, and how this understanding can be leveraged to make more reliable drugs for the patient
	Mansoor Khan

	Open Discussion – All

Friday PM IV

Continuous Manufacturing – II

Chair(s): Fernando Muzzio

Continuous manufacturing processes are currently the focus of substantial interest by the pharmaceutical industry. Due to the need to control every processing step simultaneously and continuously, they pose also substantial new challenges in process monitoring and control. In this session, we welcome contributions that demonstrate effective use of PAT methodologies for all aspects of continuous processing, including both drug substance and drug product manufacturing.

	NIR in Continuous Mixing: Transitioning from Monitoring to Control
	Rodolfo J. Romanach, University of Puerto Rico, Mayaguez, PR

	Avoiding Blend Segregation in Continuous Manufacturing (Double Time Slot)
	Professor Fernando Muzzio, Rutgers University, Piscataway, NJ

	Advanced Hybrid MPC-PID based Closed-loop Control of Continuous Pharmaceutical Tablet Manufacturing Pilot-plant
	Ravendra Singh, Abhishek Sahay, Krizia M. Karry, Maitraye Sen, Rodolfo J. Romanach, Fernando Muzzio, Marianthi Ierapetritou and Rohit Ramachandran, Rutgers University, Piscataway, NJ

	Interaction of Material Properties and Process Parameters in Continuous Manufacturing
	Ms. Amanda Roger, Rutgers University, Piscataway, NJ

	Multi-scale Model Development and Validation of Continuous Pharmaceutical Processes: Toward QbD in Drug Product Manufacturing
	Rohit Ramachandran, Rutgers University, Piscataway, NJ

	PAT Data Management to Enable Advanced Process Monitoring and Control on Hot Melt Extrusion Lines
	Kjell Francois, Siemens, Brussels, Belgium

	Optical Coherence Tomography for in-line Quality Control of Pharmaceutical Film-Coated Tablets
	Daniel Markl, Research Center Pharmaceutical Engineering GmbH, Styria, Austria

	Traceability of Raw Materials in Pharmaceutical Continuous Manufacturing
	William Engisch, Rutgers University, Piscataway, NJ

	Non-Destructive Characterization and Assessment of Pharmaceutical Oral Dosages in Continuous Manufacturing
	William J. Welsh1,2, Sastry Isukapalli2, Alberto Cuitino1, Fernando Muzzio1, Rodolfo Romanach3, Bozena Michniak-Kohn1, 1 Rutgers- The State University of New Jersey, Piscataway, New Jersey, 2 Snowdon, Inc., Princeton, New Jersey, 3 Recinto University of Mayaguez, Puerto Rico

Friday PM VI

Fundamental University Research and Its Industrial Applications

Chair(s): Kevin Macias and James Drennen

	NIR Spectroscopy as a Non-destructive Tool to Predict Dissolution for Acetaminophen Tablets
	N.L. Rodriguez, E. Hernandez Torres, P. Pawar, G. Keyvan, T. Awad, B. Michniak, A. Cuitino, F.J. Muzzio, R.J. Romanach, University of Puerto Rico-Mayaguez, Department of Chemistry, Mayaguez, PR

	Reductive Degradation of Hexavalent Chromium: Effect of pH and Mass Transfer on Kincetics
	Jude O. Ighere1, Karina Honjoya2, Rodrigo Farias3 and Ramesh C. Chawla4, Chemical Engineering Department, Howard University, Washington DC, 1Graduate Student, 2Undergraduate Student, 3Undergraduate Student, 4Faculty Adviser

	A Doctoral Training Centre in Process Analytical Technology: Successes and Remaining Challenges
	Gary Montague, Newcastle University, School of Chemical Engineering And Advanced Materials, Newcastle University, Newcastle upon Tyne, Tyne and Wear, UK

	A New Center of Excellence in Process Analysis & Technology
	Karsten Rebner, Reutlingen University, Reutlingen, Germany

	Open Discussion – All

Friday PM VII

MASS Spectroscopy/Process Spectroscopy Sessions

Chair(s): Bob Bear, John Coates and George Vickers

	Tools for Streamlined Analysis of On-line Mass Spectroscopic Data
	Mark A. LaPack, Small Molecule Design and Development, Eli Lilly and Company, Indianapolis, IN and Robert R. Roginski, Eigenvector Research, Incorporated, Seattle, WA

	Characterization and Quantitation of Supplement Samples Using TGA-MS
	Charles De Carlo, Extrel CMS, Pittsburgh, PA

	Nanomaterial Screening by MS for Carbon Sequestration
	Stefano Brandani; Chiara Ferrari; Hyungwoong Ahn; and Enzo Mangano – University of Edinburgh and Tony Slapikas – AMETEK Process Instruments

	From Laboratory NIR Models Calibration to Online Low-cost Monitoring of Diesel Refinery Process
	Noemie Caillol, IFPEN, Solaize, France

	Centralized Data Collection for Improved Quality Control
	Jorge E Perez, CIC Photonics, Inc., Albuquerque, NM

	Trace Analysis of HF Impurities
	Jorge E Perez, Company: CIC Photonics, Inc., Albuquerque, NM

	Determination of Magnesium Concentration in Commercial Magnesium Stearate Samples using XRF Spectroscopy
	Sergey Mamedov,1, T.Wang2 and S.Hoag2, 1 Horiba Scientific, Edison, NJ, 2 Department of Pharmaceutical Science, University of Maryland, Baltimore, MD

	Insitu Analysis of Ammonia Slip and Water Vapor using a Tunable Diode Laser for SCR/SNCR Optimization and Boiler Tube Surveillance in Power Plants
	Warren Dean, Siemens Industry, Inc., Bartlesville, OK

Friday PM

Food Quality, Safety and Analysis Symposium – Discussion: PAT as a Quality Control Tool

Chair(s): P. J. Cullen, Ph.D., Dublin Institute of Technology, School of Food Science and Environmental Health, Dublin, Ireland, Lorenz Liesum, Ph.D., Novartis Pharma AG Global Pharma Engineering, Basel, Switzerland and Jun Huang, Pfizer

	This session will include discussions on process analytical technologies capable of providing quality control during Pharmaceutical, Biotech and food manufacturing. The business merits and strategies of PAT adoption will be discussed. The potential of PAT to support regulation strategies will be addressed.

Food Symposium Wrap-up Discussion – All

P. J. Cullen, Ph.D., Dublin Institute of Technology, School of Food Science and Environmental Health, Dublin, Ireland, Carol Zrybko, Ph.D., Mondelez International, East Hanover, NJ, Michael McCarthy, Ph.D., University of California Davis, Davis, CA, Luis E. Rodriguez-Saona, Ph.D., The Ohio State University, Columbus, OH, Bei Ma,M.S., United States Pharmacopeial Convention, Rockville, MD, Colm O’Donnell, Ph.D., University College, UCD-Dublin Institute of Food & Health, Dublin, Ireland, Steve Holroyd, Ph.D., Fonterra Research Centre, New Zealand, Lorenz Liesum, Ph.D., Novartis Pharma AG Global Pharma Engineering, Basel, Switzerland, Jun Huang, Pfizer, et al.

Posters

Chair(s): Antonio Moreira and Walter Henslee

	QTA Marine Oil Analysis
	Kirsten Kramer, Ching-jui Tseng, Kangming Ma, Eurofins Quality Trait Analysis (EQTA), West Chester, OH

	Advanced Interfaces for Combined Electrochemical/Optical Biosensing
	Ryan West and Steve Semancik, National Institute of Standards and Technology, Gaitherburg, MD

	Automated Online Reaction Monitoring by UHPLC Enabled by a Novel Process Sample Manager
	Aaron Phoebe, Waters Corporation, Milford, MA

	The High-speed and High-sensitivity Near Infrared Spectrometer for In-line Monitoring of the Fluidized Bed Granulator and Controlling Moisture in Low-level
	Kodai Murayama, Hiroyuki Sugino and Makoto Komiyama, Yokogawa Electric Corp., Tokyo, Japan

	Drug Re-purposing using Inhibitors to Inhibit Amyloid-beta Binding in a Cell Culture Model of Alzheimer’s Disease
	Niloufar Pezeshk and Theresa A. Good, UMBC, Catonsvile, MD

	Inline Fluorescence Sensor for Protein Measurement in Whey Permeate
	Fred Payne, Reflectronics, Inc., Lexington, KY

	Gaining Optimized Cell-Level Observability and Data-Driven Process Guidance by Leveraging On-line Technologies such as Dielectric Spectroscopy and At-line tools such as the Modular Automated Sampling Technology (MASTTM) Platform
	Clint Pepper Ph.D., Bend Research Inc., Bend, OR

	Diaphragm-sealed Valve for Hazardous Applications
	Yves Gamache, Norgren AFP, Thetford Mines, Canada

	IR and NMR Reaction Monitoring Techniques for Nucleophilic Addition Reactions using a Pyridinium Salt
	Howard Ward, Pfizer, Groton, CT

	OCT-Based Freeze-drying Microscopy
	Brian Murphy Ph.D., Physical Sciences Inc., Andover, MA

Quantifying Galactosamine Content in Heparin by Combining Proton NMR Spectral Data and Multivariate Chemometric Analysis

Qingda Zang1,4*, David A. Keire2, Lucinda F. Buhse2, Christine M. V. Moore3, Moheb Nasr3**, Ali Al-Hakim3, Michael L. Trehy2, and William J. Welsh1,4 1 Department of Pharmacology, Robert Wood Johnson Medical School, Rutgers University, Piscataway, NJ, 2 Food and Drug Administration, CDER, Division of Pharmaceutical Analysis, St Louis, MO, 3 Food and Drug Administration, CDER, Office of New Drug Quality Assessment, Silver Spring, MD, 4 Snowdon, Inc., Princeton, NJ, * Present address: National Center for Computational Toxicology, US Environmental Protection Agency, Research Triangle Park, NC, ** Present address: GlaxoSmithKline, Collegeville, PA

Classification of Heparin Samples Containing Impurities and Contaminants by Proton NMR Spectroscopy and Chemometrics

Simultaneous Determination of Impurity and Contaminant Content in Heparin by Chemometric Analysis of Proton NMR Spectral Data

	Biological Spectra Analysis Profiles in Chemical Toxicology: Linking the Bioactivities and Molecular Structures of Chemical Datasets
	Dmitriy Chekmarev, Vladyslav Kholodovych, and William J. Welsh, Rutgers University, Robert Wood Johnson Medical School, Piscataway, NJ

	Real-time Culture Nutrient Consumption Rate Determination and Continuous Feed Control Platform
	William Miller, Lucas Schimmelpfenning, Paul Strand and Michael Biksacky, Flownamics, Inc., Madison, WI

	Terahertz (THz) Mapping of Compacted Solids
	David Heaps, Advantest, Princeton, NJ

	Non-Destructive Characterization and Assessment of Pharmaceutical Oral Dosages in Continuous Manufacturing
	William J. Welsh1,2, Sastry Isukapalli2, Alberto Cuitino1, Fernando Muzzio1, Rodolfo Romanach3, Bozena Michniak-Kohn1, 1 Rutgers- The State University of New Jersey, Piscataway, New Jersey, 2 Snowdon, Inc., Princeton, New Jersey, 3 Recinto University of Mayaguez, Puerto Rico