IFPAC - 2014
®
TWENTY-EIGHTH INTERNATIONAL FORUM & EXHIBITION
QUALITY BY DESIGN…QbD
PROCESS ANALYTICAL TECHNOLOGY
Crystal Gateway Marriott, Arlington, Virginia (Washington, D.C.) U.S.A.
January 21-24, 2014
www.ifpacpat.org
PRESS RELEASE
STILL TIME TO REGISTER
IFPAC-2014 is less than one month away!
Join your colleagues for this prestigious event. For more details on registration visit www.ifpacpat.org.
SHOW PREVIEW
Conference Overview
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.
The Program
IFPAC-2014 will feature comprehensive Pharmaceutical/Biotechnology tracks covering multiple areas of
interest including Quality by Design-QbD, Biotechnology, Process Monitoring & Control, Imaging, Process
Analysis/Spectroscopy, Separations, and Food Quality, Safety & Analysis. IFPAC-2014 will also be held
in conjunction with a Symposium for the Generic Industry. The extensive program will bring in leading
experts from across the globe covering important research, trends, technological advances, case studies
and the latest in regulatory guidance.
This conference is forward thinking with high profile speakers from International and U.S. Regulatory
Agencies, NIST, CPAC, MIT, Duquesne, Rutgers, and global representatives from numerous
Pharmaceutical & Biotechnology corporations.
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Meet with new and existing colleagues to discuss solutions to common problems
Network with Regulatory, Academia, Students & Industry Leaders
See the Latest Trends & Technologies in the Exhibition Hall
More Q&A during the Expanded Poster Session
Panel Discussions, Roundtables, and Evening Dinners
A comprehensive exhibition of PAT equipment and services, poster sessions, and social events will be
available throughout the conference to provide numerous opportunities for networking and informal
meetings. ...see our web pages www.ifpacpat.org for more information www.ifpacpat.org
EVENT CHECK-LIST - IFPAC-2014 HAS IT ALL!
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PROCESS CONTROL & MONITORING
QUALITY BY DESIGN (QbD)
CONTINUOUS MANUFACTURING
LIFECYCLE MANAGEMENT
RISK MANAGEMENT
ANALYTICAL QbD
INTERNATIONAL QbD
GENERIC INDUSTRY APPLICATIONS
BIOPHARMACEUTICALS/BIOPROCESSING
THREE DAY EXHIBITION
NUMEROUS NETWORKING OPPORTUNITIES
IFPAC provides a unique opportunity to interact with other industries that have been using PAT
for nearly 60 years!
IFPAC-2014: Pre-Conference Short Courses
Monday, January 20, 2014
Tuesday, January 21, 2014
Short Course I: Monday, January 20th - AM
Process Control for Chemists, Pharmacists & Formulation Scientists
Julian Morris, Technical Director, Centre for Process Analytics and Control Technology, Newcastle
University, School of Chemical Engineering & Advanced Materials, Newcastle upon Tyne, UK
Short Course II: Monday, January 20th - PM
In a Nutshell: Design of Experiments
Juergen von Frese, Data Analysis Solutions DA-SOL GmbH, Germany
Short Course III: Tuesday, January 21st - AM
8:30 a.m. to 12:00 p.m.
End-to End Business Excellence with PAT and QbD
Prof Jose C Menezes, Technical University of Lisbon
Dr. Pedro G Felizardo, 4Tune Engineering Ltd
Registration for the Short Courses should be completed as part of the IFPAC-2014 Conference
Registration Form, or please contact info@ifpacnet.org / 847-543-6800 to register or with
questions.
Pre-Conference Workshop
TUESDAY, JANUARY 21, 2014 – PM
Control Strategy in Continuous Manufacturing
Chairs: 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!
SCHEDULE OF EVENTS
Wednesday, January 22, 2014 – AM
IFPAC PLENARY
Chairs: Sharmista Chatterjee, FDA, Mark A. LaPack, Gawayne Mahboubian-Jones and Paul Vahey
Welcome/Introduction by the IFPAC-2014 Chairs
CDER's Office of Pharmaceutical Quality (OPQ): Delivering on the 21st Century Quality Goals,
Lawrence Yu, FDA, CDER, OPQ
How Quality by Design & Associated Enabling Technologies Influence Business Strategy,
Christopher Sinko, Senior Vice President, Pharmaceutical Development, Bristol-Myers Squibb
Continuous API Synthesis: Development, Optimization, and Scaling, Klavs F. Jensen, Warren K
Lewis Professor and Department Head Department of Chemical Engineering, MIT
Big Data (TBA), Jim Petrusich, Vice President, Northwest Analytics, Manufacturing Intelligence for
Intelligent Manufacturing
New Chemistry, New Science for Industrial Innovation, Professor George M. Whitesides, Department
of Chemistry & Chemical Biology, Harvard University, Cambridge, MA
Check our webpages for updates at www.ifpacpat.org
Wednesday, January 22, 2014 - PM
Continuous Manufacturing
Continuous Manufacturing - I
Chairs: Vibhakar Shah, FDA and Theodora Kourti
BioPharma/BioProcessing
Rapid Micro Methods (RMM) for Manufacturing Roles
Chairs: Jeff Weber and Bryan Riley, FDA
Lifecycle Management
Risk Management Over Product Life Cycle - I
Chairs: G. K. Raju & Rick Freeman, FDA
International QbD
International Harmonization on QbD: Recent Experience
Chairs: Evdokia Korakianiti, EMA and Christine Moore, FDA
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.
Process Raman
Chair: Brian Marquardt
Advanced Separations
Chair: John Crandall
Thursday, January 23, 2014 – AM
QbD - Quality by Design
QbD - I: Implementation of QbD for Small Molecules
Chairs: Lorenz Liesum and Sarah Pope Miksinki, ONDQA/FDA
BioPharma/BioProcessing
Bio-Tech - I: Real Time Monitoring of Bio-Reactors and Bio-Processing
Chairs: Kurt Brorson and Michael Tarlov
Lifecycle Management
Risk Management Over Product Life Cycle - II
Chairs: G. K. Raju & Daniel Peng, FDA
Special IQ Session
Multivariate Model Validation in a Quality Environment
Chairs: Doug Both and George L. Reid
Process Control & Monitoring
Process Monitoring & Control - II: Process Automation/Intelligence Based Manufacturing (IbM)
Chairs: Mojgan Moshgbar, Ke Hong and Tahseen Mirza, FDA
Plus... Chemometrics (COPA) – I, and Advanced Instruments Concepts
Thursday, January 23, 2014 – PM
QbD - Quality by Design
QbD - II: Implementation of QbD for Complex Dosage Forms
Chairs: Sharmista Chatterjee, FDA, and Theodora Kourti
BioPharma/BioProcessing
BioTech - II: MSAT in Biologics Manufacturing
Chairs: Ranjit R. Deshmukh and Jose C. Menezes
Lifecycle Management
Lifecycle Management of Analyzer and Method Robustness
Chairs: Gert Thurau and Martin Warman
Generic/Brand Industry Applications
Using Process Capability to Ensure Pharmaceutical product Quality - Industry and Regulatory
Perspective
(Brand and Generics)
Chairs: Lawrence Yu, FDA and Daniel Peng, FDA
Process Control & Monitoring
Process Monitoring & Control - I: PAT Implementation for Drug Product Development &
Manufacturing
Chairs: Tim Stevens and Gawayne Mahboubian-Jones
NeSSI
Chair: Mel Koch
Plus… Imaging and Process Spectroscopy
Friday, January 24, 2014 – AM
Analytical QbD
Implementation of QbD for Analytical Methods
Chairs: Sonja Sekulic and John Kauffman, FDA
Special ISPE Session
Next Stage of QbD Implementation
Chairs: Stephen Tyler and Theodora Kourti
BioPharma/BioProcessing
Bio-Tech - III: Bio-Processing/Bio-Transformations
Chairs: Antonio Moreira and John Higgins
QbD - Quality by Design
QbD in CMO/CRO
Chair: Manoharan Ramasamy
Generic Industry Symposium
QbD and PAT in the Generic Industry
Chairs: Daniel Peng, FDA and Inna Ben-Anat
Process Control & Monitoring
PAT Links to Post-Approval Manufacturing (PV and CPV)
Chairs: Ranjit Deshmukh, Tara Gooen, FDA and Vibhakar Shah, FDA
Plus... Chemometrics (COPA) – II, Particle Characterization, and Handheld/Screening Joint
IFPAC/OnSite Session
Friday, January 24, 2014 – PM
QbD - Regulatory
QbD - III: Regulatory Discussion Session...Topic: Implementation of Question based Review (QbR)
for Generic & Brand Industry
Chair: Sharmista Chatterjee, FDA
BioPharma/BioProcessing
Process Control for Biotechnology/Pharmaceutical
Chairs: Cenk Undey and Jose C. Menezes
Lifecycle Management
Lifecycle Control and QA
Chairs: Rick Friedman, FDA and Tom Garcia
Continuous Manufacturing
Continuous Manufacturing - II
Chair: Fernando Muzzio
Plus... Fundamental University Research & Its Industrial Applications, and MASS Spectroscopy/Process
Spectroscopy
Please visit our website for continuous updates: www.ifpacpat.org
IFPAC Posters on Thursday and Friday: Located in the Exhibit Hall
Chairs: Antonio Moreira and Walter Henslee
Exhibition Schedule:
Wednesday, January 22nd ..........2:00 - 7:00 PM
Grand Opening ..................2:00 PM
Thursday, January 23rd ..............10:00-4:00 PM
Friday, January 24th ....................9:00-12:00 Noon
Join Your Fellow Exhibitors at IFPAC-2014: Don’t miss this opportunity. Full exhibition services will be
provided during the three day exhibit. Companies interested in exhibiting are invited to contact exhibition
management as soon as possible. Email: info@ifpacnet.org Tel: 847-543-6800.
To Register:
Please contact IFPAC at:
Tel: 847-543-6800; Fax: 847-548-1811
Email: info@ifpacnet.org
Register Online at Web Page: www.ifpacpat.org
IFPAC