IFPAC®-2012
The Twenty-Sixth International Forum and Exhibition
Quality by Design…QbD
Process Analytical Technology… PAT
January 22-25, 2012
Baltimore Marriott Waterfront
Baltimore, Maryland, U.S.A.
IFPAC-2012: Global Solutions for Process Understanding and Control
Multiple sessions/tracks on QbD, PAT, Continuous Manufacturing, Real-Time
Release, Biotechnology, Imaging, Food, and more…
A Full 3.5 Day Event Dedicated to PAT and QbD!
ISPE will also be presenting its PQLI Initiative during IFPAC, plus IFPAC-2012 will
include a high profile plenary, QbD Evening Discussion Session, numerous networking
opportunities and several tracks that will be of interest to ISPE members.
An ISPE member discount is available. Contact info@ifpacnet.org for more details.
The Event:
IFPAC is the essential meeting place for the latest developments in Process Analytical
Technology...PAT and Quality by Design...QbD within the Pharmaceutical,
Biotechnology & related industries. IFPAC is known for being a collaborative forum to
exchange ideas and network through panel discussions, evening sessions, poster
sessions, and the exhibition. For over 25 years IFPAC has brought together industry,
academia, research institutions, manufacturers/suppliers, and government to discuss
trends in technology, standards, and controls.
IFPAC attendees come to learn more about how they can boost productivity, streamline
implementation processes, enhance operational efficiency, and maximize their
resources.
IFPAC-2012 continues to attract high profile speakers with scheduled representatives
from International and U.S. Regulatory Agencies, NIST, NIPTE, CPAC, CPACT, MIT,
Duquesne, Rutgers and numerous Biotechnology, Pharmaceutical,
Chemical/Petrochemical corporations…
IFPAC-2012 will have representatives from Austria, Canada, China, Denmark, Finland,
Germany, India, Ireland, Japan, New Zealand, Portugal, Saudi Arabia, United Kingdom,
United States and more…a truly International event.
Program Overview:
IFPAC is very pleased to have Janet Woodcock, M.D., Director of the Center for Drug
Evaluation and Research (CDER) at the Food and Drug Administration (FDA) lead off
the plenary. Plus an update on QbD and PAT from the European Medicines Agency; the
Senior Vice President of Global Science Technology and Commercialization of Merck’s
Manufacturing Division; the Director of Marketing for Environmental and Industrial
Segments (Instruments), Perkin Elmer; and more…
IFPAC-2012 will feature comprehensive Pharmaceutical/Biotechnology tracks including
the topics: Pharmaceutical Product Performance, Control Strategies for Drug
Development & Manufacturing, Process Control, Sampling, Real-Time Release,
Continuous Manufacturing, Risk Management, Bio-Processing, BioReactors, PAT
Applied for Biologics Manufacturing, Life Cycle Management of Analyzer and Method
Reliability, Imaging, Particle Characterization, Screening and Surveillance, and various
analytical techniques including: NIR, Raman, MS and LIF... plus involvement by the
International Consortium for Innovation and Quality in Pharmaceutical Development.
Other topics to include the latest information on advanced instrumental concepts for
process analysis, new sensor technology, imaging techniques, manufacturing, control
strategies, Process Raman, Near Infrared Spectroscopy, process communications,
particle characterization/analysis, LIF, Mass Spec, and data management.
Plus a Pre-Conference Short Course on QbD Tools in Process Development and
Manufacturing, Sunday Morning, Jan. 22, 2012. For more details visit www.ifpacpat.org.
A precon workshop on the Implementation of Quality Systems - (Emphasizing NIR) will
be held Sunday afternoon, January 22nd.
Program Highlights:
Several sessions related to instrumentation, techniques, case studies, and data
management will be at IFPAC-2012. Following the Plenary Monday morning, attendees
will have several sessions to choose from:
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Monday Afternoon – ISPE Sponsored Session, QbD, Real-Time Release,
Advanced Instrument Concepts, Risk Management, Raman
Tuesday Morning – QbD, Control Strategies for Drug Development &
Manufacturing, Advanced Separations, Chemometrics I, Chemical Imaging,
BioReactors
Tuesday Afternoon –Chemometrics II, Advanced Separations/Mass Spec,
Process Control, Imaging II, PAT Applied for Biologics Manufacturing, PAT
Approaches to Continuous Manufacturing
Wednesday Morning - Continuous Manufacturing, BioProcessing, Screening &
Surveillance/Handheld Instrumentation, Particle Characterization, Tools & Case
Studies for Process Understanding and Control, Life Cycle Management and
Analyzer Reliability
Wednesday Afternoon – QbD, Contract Manufacturing & PAT, Process
Communications, Process Analysis/Spectroscopy, Real-Time Light Induced
Fluorescence (LIF), Bridging the Quality Gap between Benchtop and Field
Instruments, Role of Excipients in QbD
ISPE Sponsored Session - Topics to include the PQLI Launch of QbD Documents and
Future PQLI Vision, Steve Tyler, Abbott; Introduction to Illustrative Example, IE, Bruce
Davis, Global Consulting; IE – Criticality, Roger Nosal, Pfizer; IE - Design Space, John
Lepore, Merck; IE- Control Strategy, Line Lundsberg – Nielsen, NNE Pharmaplan; Data
and Knowledge Management as a Key Success Factor for QbD Implementation,
Andreas Schneider, Roche; Strategies for the Verification of Design Space, Tom Garcia,
Pfizer; Benefits by QbD Implementation – Results of a Survey, Dora Kourti, GSK and a
Round Table Discussion - PQLI Project Realization and QbD.
QbD – Topics such as the Development and Implementation of Innovative, Risk-based
Control Strategies Under QbD Framework, Merck Sharp & Dohme; Whole Process
Analysis within the QbD Framework, 4tune Engineering Ltd, Data Analysis Solutions;
De-risking Scale-up of a High Shear Wet Granulation Process Using Latent Variable
Modeling and Near Infrared Spectroscopy, Pfizer Inc.; Commercial Site Implementation
of QbD: Two Opposing Realizations of Process Control to Ensure Quality, Bristol-Myers
Squibb; Importance of More Flexible use of PAT in a Japanese Pharmaceutical Society,
Astellas Pharma Inc. and PAT committee of Japan Society of Pharmaceutical Machinery
and Engineering (JSPME); Roll-out of a PAT drying application to four sites:
Achievements, surprises and lessons learned, Novartis, Switzerland; How does
Continuous Process Validation Drive Product performance Monitoring and
Understanding Variability, GSK; Multivariate Techniques as Part of a Corporate PAT
Strategy, Umetrics; plus perspectives from the FDA and more.
PAT Approaches for Continuous Manufacturing - 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. Speakers including representatives from Rutgers University, University of
Eastern Finland, VTT Technical Research Centre of Finland, University of Puerto RicoMayaguez, Glatt Systemtechnik GmbH in Germany, and the regulatory agencies.
Pharmaceutical Product Performance: Expected and Actual - This session will
discuss the value in estimating and monitoring pharmaceutical product performance.
Raw material and process parameters are investigated during the development phases
of a project, and the knowledge obtained is refined as experience is gained throughout
the lifecycle of the project. This session will 1) explore process model’s developed at
small scale and their usefulness at predicting quality (performance) at small and large
scale, and 2) investigate how modeling of the variation in quality (e.g. standard
deviation), in addition to standard process models, can enhance prediction of
commercial product performance. It will be shown that the latter can be useful in not only
setting appropriate specifications based on process capability but also in predicting
process capability of commercial lots.
Contract Manufacturing & PAT - QbD at CMO: Linking Process Development with
Manufacturing Towards Lifecycle Performance, Hovione, Portugal; Making the Most of
your Data: Knowledge Management with Contract Manufacturing Organizations, Vertex
Pharmaceuticals; PAT Implementations, Lonaz, Inc., Visp, Switzerland; PAT Method
Transfer and Implementation in a CMO Site for Real Time Monitoring and Controlling
Precision Active Coating: A First Impression, Merck; and Process Analytical Technology
(PAT) in working with CRO, Bristol-Myer Squibb
Evening Sessions Discussions including QbD and Sampling - Large Sample Sizes
for Batch Release Decisions.
Plus Posters Sessions… An excellent opportunity for one on one discussions and
networking.
With over 30 topics covering all industry segments – IFPAC provides an
opportunity to interact with industries that have been using Process Analytical
Technology for nearly 60 years!
IFPAC-2012 EXHIBITION
Monday, January 23rd................2:00 - 7:00 PM
Grand Opening..................2:00 PM
Tuesday, January 24th..........10:00-4:00 PM
Wednesday, January 25th..............9:00-12:00 Noon
Exhibitors at this year’s event include:
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ABB Analytical Measurement
Advantest Corporation
Agilent Technologies
American Pharmaceutical Review
(AIT) Applied Instrument Technologies
Automation.com
ASTM
BaySpec, Inc.
BioPharmaceutical International
Bruker
BUCHI Corporation
Canty
CDS Analytical
CIRCOR Technologies
COBALT Light Systems
CPAC, Center for Process Analytical Chemistry
CPACT
Custom Sensors & Technology
DASGIP Biotools
Duquesne University/SPCTECH
DURASENS
Eisai Machinery, U.S.A., Inc.
Emerson Process Management/Rosemount Analytical
Enwave Optronics, Inc.
European Pharmaceutical Review
Extrel CMS
4TUNE Engineering, Ltd.
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FOSS NIRSystems, Inc.
FTRX LLC
Hamilton Company
IFPAC
ISPE
Kaiser Optical Systems, Inc.
LC/GC
Nova Biomedical
Pharmaceutical Manufacturing
PharmaQbD.com
Polytec
Real-Time Analyzers, Inc.
Rimbach
Rosemount Analytical
RURO, Inc.
Sartorius Stedim
Scientific Systems
Siemens Industry, Inc.
Spectroscopy
StatSoft, Inc.
Stratophase, Ltd.
Swagelok Co., LLC.
Thermo Scientific
Thermo Scientific-Scientific Instruments
Uhlmann VisioTech GmbH
Umetrics
Waters Corporation
Wilco
It's an opportunity to see and be seen by old and new colleagues and customers. Those
companies interested in exhibiting at IFPAC-2012 are invited to contact conference
management as soon as possible.
Registration Information
This premier event is being held January 22-25, 2012 at the Baltimore Marriott
Waterfront Hotel, located within Baltimore's Inner Harbor.
Local and All Inclusive Registration is Available… www.ifpacpat.org.
For more information contact: 847-543-6800; info@ifpacnet.org; www.ifpacpat.org
IFPAC®… First Name in PAT… the Essential Meeting Place for PAT