Program Overview

IFPAC - 2015
®
TWENTY-NINTH INTERNATIONAL FORUM & EXHIBITION
QUALITY BY DESIGN…QbD
PROCESS ANALYTICAL TECHNOLOGY
Crystal Gateway Marriott, Arlington, Virginia (Washington, D.C.) U.S.A.
January 25-28, 2015
www.ifpacpat.org
ADVANCE WITH IFPAC
…Pathway to Quality Manufacturing
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, Chemical, Petrochemical &
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, as well as
International and U.S. Regulatory Agencies to discuss the latest trends in technologies, standards and
controls.
IFPAC-2015 HAS IT ALL!
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PROCESS CONTROL & MONITORING
QUALITY BY DESIGN (QbD)
CONTINUOUS MANUFACTURING
REAL TIME RELEASE TESTING
LIFECYCLE MANAGEMENT
RISK MANAGEMENT
ANALYTICAL QbD
INTERNATIONAL HARMONIZATION
QUALITY METRICS
POST-APPROVAL MANUFACTURING
ENABLING TECHNOLOGIES
GENERIC INDUSTRY APPLICATIONS
BIOPHARMACEUTICALS/BIOPROCESSING
CONTINUOUS EMISSIONS MONITORING
ADVANCED INSTRUMENTS CONCEPTS
ADVANCED SEPARATIONS
CHEMOMETRICS
NESSI
VARIOUS ANALYTICAL TECHNIQUES
PLUS… PRECON EVENTS, THREE DAY EXHIBITION AND NUMEROUS NETWORKING
OPPORTUNITIES
The Program
IFPAC-2015 will feature comprehensive tracks covering multiple areas of interest including Quality by
Design-QbD, Continuous Manufacturing, Real-Time Release Testing, Risk Management, Lifecycle
Management, Post-Approval Manufacturing, Analytical QbD, International Harmonization, Enabling
Technologies, Biotechnology, Process Monitoring & Control, Imaging, Process Analysis/Spectroscopy,
Separations, and Food Quality, Safety & Analysis. An expanded program has been developed for the
chemical and petrochemical industries with current and important topics including Advanced Instrument
Concepts, Continuous Emissions Monitoring, Sample Handling…NeSSI, chemometrics…COPA and
improvements in process analysis. IFPAC-2015 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
IFPAC provides a unique opportunity to interact with other industries that have been using PAT
for nearly 60 years!
IFPAC-2015: SCHEDULE OF EVENTS
Sunday, January 25, 2015 - AM
Pre-Conference Short Courses:
SHORT COURSE I: 8:30 AM - 12:00 PM
QbD – Manufacturing Sciences & Technologies
Prof Jose C Menezes, Technical University of Lisbon
Dr Pedro G Felizardo, 4Tune Engineering Ltd
SHORT COURSE II: 8:30 AM – 12:00 PM
Root Cause Analysis / Problem Solving
Juergen von Frese, Ph.D., Data Analysis Solutions, Germany, www.da-sol.com and Walter Henslee, Dow
Chemical Lead PAT Scientist, retired
Please visit www.ifpacpat.org for more details.
Sunday, January 25, 2015 – PM
Pre-Conference Regulatory Workshop
Post Approval Change Management for PAT and RTRT-Scientific & Regulatory Considerations
Chairs: Christine Moore, FDA and Theodora Kourti, GSK
HPLC Workshop
Monday, January 26, 2015 – AM
IFPAC PLENARY
Chairs: Scott Armstrong, John Kauffman, G.K. Raju and Martin Warman
Keynote Speakers Including…
Lawrence Yu, Director of OPS, FDA, Silver Spring, MD
Kevin Nepveux, VP, Pfizer
Chris Love, Professor, MIT, Lead on MIT DARPA Program
Patricia Hurter, VP, Vertex Pharmaceuticals, Boston, MA
Don Bartusiak, ExxonMobil
Monday, January 26, 2015 - PM
International Harmonization for Implementation of Risk Based Review and Inspection
Sharmista Chatterjee, FDA and Dolores Hernan, EMA
Risk Management Over Product Life Cycle – I (Brand)
Chairs: G. K. Raju, Light Pharma and Rick Friedman, FDA
Process Monitoring & Control – I: Part 1: IbM – The Vision, Business Case, and Outlook
Chairs: Jun Huang and Mojgan Moshgbar
Process Monitoring & Control – I: Part 2: IbM – Making it Real!
Chairs: Gretchen Allison and Vibhakar Shah
Implementation of QbD for Analytical Methods
Chairs: John Kauffman, FDA and Sonja Sekulic, Pfizer
BioTech – I: Small Molecule Manufacturing & the Application of PAT & QbD
Chairs: Antonio Moreira, University of Maryland-Baltimore County and John Higgins, Merck
QbD – Applications and Tools – I
Chairs: Scott Furness, FDA, Theodora Kourti, GSK, Manoharan Ramasamy, Merck, and Lorenz Liesum,
Novartis
Process Raman
Chair: Brian Marquardt, CPAC, APL, University of Washington
Chemometrics (COPA) – I
Chairs: Juergen von Frese, Data Analysis Solutions DA-SOL GmbH, Christian Airiau, GSK and Brian
Rohrback, Infometrix
Microscopy/Spectroscopy/Sensors
Chair: Jason Dickens, GSK (TBC)
Monday Evening, January 26, 2015
Discussion Session I - NIRS Guideline by EMA – What are the Implications for Industry?
Panel: Theodora Kourti, GSK, Lorenz Liesum, Novartis and Sonja Sekulic, Pfizer
Special Evening Session- Training the Next Generation: Process Analyzer Technicians
Chairs: Scott Armstrong, ExxonMobil and J.D. Tate, Dow Chemical
Tuesday, January 27, 2015 – AM
QbD – Applications and Tools – II
Chairs: Scott Furness, FDA, Theodora Kourti, GSK, Manoharan Ramasamy, Merck and Lorenz Liesum,
Novartis
Risk Management Over Product Life Cycle – II (Generics)
Chairs: G. K. Raju, Light Pharma and Daniel Peng, FDA
Process Monitoring & Control - II: PAT Implementation for Drug Product Development and
Manufacturing
Chairs: Tim Stevens, BMS and Ajit S. Narang, BMS
Lifecycle Management of Analyzer and Method Robustness
Chairs: Gert Thurau, Roche and John Kauffman, FDA
BioTech – II: MSAT in Biologics Manufacturing
Chairs: Jose C. Menezes, IST, UTL, Portugal and Ranjit R. Deshmukh, MedImmune
Imaging
Chairs: Steve Hammond, Pfizer and Carl Anderson, Duquesne University
NeSSI
Chair: Mel Koch, APL, University of Washington
Advanced Separations – I: Technology & Applications (FastGC, HPLC, Data Systems)
Chair: John Crandall, Falcon Analytical
Food-I: Emerging Technologies with Focus on Traceability and Contamination
Chairs: Michael McCarthy, Ph.D., University of California Davis, Davis, CA and Carol Zrybko, Ph.D.,
Mondelez International, East Hanover, NJ
Tuesday, January 27, 2015 – PM
QbD – Applications and Tools – III
Chairs: Scott Furness, FDA, Theodora Kourti, GSK, Manoharan Ramasamy, Merck and Lorenz Liesum,
Novartis
Product Lifecycle and QA
Chairs: Tara Gooen Bizjak, FDA and Ravi Tejwani, BMS
Using Process Capability to Ensure Pharmaceutical Product Quality – Industry and Regulatory
Perspective (Brand and Generics)
Chair: Daniel Peng, FDA, Alex Viehmann, FDA and George Millili, Genentech – ISPE
Enabling Technologies to Continuous Manufacturing
International Consortium for Innovation and Quality in Pharmaceutical Development - IQ
Chairs: Doug Both, BMS and Sonja Sekulic, Pfizer
BioTech - III: Process Control for Biotechnology/Pharmaceutical
Chairs: Cenk Undey, Amgen and Jose C. Menezes, IST, UTL, Portugal
Particle Characterization
Chairs: Ewa Marszal, FDA and Zhigang Sun, FDA
Mass Spectroscopy/Process Spectroscopy
Chairs: Bob Bear, Ametek and John Coates, Coates Consulting
Advanced Separations – II: Technology & Applications (FastGC, HPLC, Data Systems)
Chair: John Crandall, Falcon Analytical
Food-II: Food Safety
Chairs: Luis E. Rodriguez-Saona, Ph.D., The Ohio State University, Columbus, OH and Bei Ma, M.S.,
United States Pharmacopeial Convention, Rockville, MD
IFPAC Poster Session
Chairs: Antonio Moreira, University of Maryland, Baltimore County and Walter Henslee, Dow Chemical
Lead PAT Scientist, retired
Tuesday Evening, January 27, 2015
Discussion Session II: A Proposal for a Drug Product Manufacturing Classification System (MCS)
for Oral Solid Dosage Forms
Chair: Theodora Kourti, GSK
Wednesday, January 28, 2015 – AM
QbD and PAT in the Generic Industry
Chair: Dr. Geoffrey Wu, FDA and Inna Ben Anat, Teva Pharmaceuticals
Continuous Manufacturing - I
Chairs: Rapti Madurawe, FDA and Theodora Kourti, GSK
Fundamental University Research and its Industrial Applications
Chairs: Kevin Macias, BMS and James Drennen, Duquesne University
Blend Uniformity/Content Uniformity
Alex Viehmann, FDA and Tom Garcia, Pfizer - ISPE
BioTech – IV: Real Time Monitoring of Bio-Reactors and Bio-Processing
Chairs: Kurt Brorson, FDA and Michael Tarlov, NIST
Advanced Instruments Concepts
Darren P. Hydutsky, DuPont, J.D. Tate, Dow Chemical, Jason Dickens, GSK and Troy Francisco, DuPont
Chemometrics (COPA) – II
Chairs: Christian Airiau, GSK, Juergen von Frese, Data Analysis Solutions DA-SOL GmbH and Brian
Rohrback, Infometrix
Screening/Surveillance/Handheld (IFPAC/OnSite Joint Session)
Chairs: Paul DeRose, NIST and Paul Vahey, The Boeing Company
Food-III: PAT for the Dairy Industry
Chairs: Colm O’Donnell, Ph.D., University College, UCD-Dublin Institute of Food & Health, Dublin,
Ireland, Brent R. Young, Professor and Head Chemical and Materials Engineering, The University of
Auckland, New Zealand and Steve Holroyd, Ph.D., Fonterra Research Centre, New Zealand
Wednesday, January 28, 2015
IFPAC Poster Session / Student Poster Day
Chairs: Antonio Moreira, University of Maryland Baltimore County and Walter Henslee, Dow Chemical
Lead PAT Scientist, retired
Wednesday, January 28, 2015 – PM
Continuous Process Verification (CPV) – the Ultimate PV Frontier and Continual Improvement
Enabler: Practices, Challenges and Opportunities
Chairs: Vibhakar Shah, FDA and Ranjit Deshmukh, MedImmune
Continuous Manufacturing – II
Fundamentals of Manufacturing Science
Chairs: Fernando Muzzio, Rutgers University and Eric Jayjock, J&J
Quality Metrics
Russell Wesdyk, FDA and Stephen Tyler, AbbVie - ISPE
Process Control and Quality
Chair: Walter Henslee, Dow Chemical Lead PAT Scientist, retired
CEMS Technology and Emerging Regulatory Requirements
Chair: Matthew MacConnell, Air Products
PAT Implementation
Chairs: James Cheney, Celgene and Martin Warman, Vertex Pharmaceuticals
Food-IV: PAT As A Quality Control Tool
Chairs: P. J. Cullen, Ph.D., Dublin Institute of Technology, School of Food Science and Environmental
Health, Dublin, Ireland
See our website for additional details and continuous updates: www.ifpacpat.org
IFPAC Posters: Located in the Exhibit Hall
Chairs: Antonio Moreira, University of Maryland-Baltimore County and Walter Henslee, Dow Chemical
Lead PAT Scientist, retired
Poster Session will run Tuesday PM through Wednesday including a Special Student Poster Session on
Wednesday
Exhibition Schedule:
Monday, January 26th ..........2:00 - 7:00 PM
Grand Opening ..................2:00 PM
Tuesday, January 27th ..............10:00-4:00 PM
Wednesday, January 28th ....................9:00-12:00 Noon
Join Your Fellow Exhibitors at IFPAC-2015: 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: [email protected] Tel: 847-543-6800.
To Register:
Please contact IFPAC at:
Tel: 847-543-6800; Fax: 847-548-1811
Email: [email protected]
Register Online at Web Page: www.ifpacpat.org
IFPAC