IFPAC-2014 Show Preview – QbD & PAT

Twenty-eighth international forum & exhibition quality

Quality by Design…QbD

Process analytical technology

Crystal Gateway Marriott, Arlington, Virginia (Washington, D.C.) U.S.A. January 21-24, 2014

SHOW PREVIEW …At the Crossroads of Process Control and Monitoring

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.

• 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!

• 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. Please contact [email protected] or 847-543-6800 with any questions.

Pre-Conference Workshop
TUESDAY, JANUARY 21, 2014 – PM

Control Strategy for 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 the control strategy considerations for continuous manufacturing of Drug Product and Drug substance. Specific points to consider related to continuous manufacturing will be presented by an academic speaker. Finally regulatory perspectives will be presented by FDA and EMA.

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

Big Data (TBA), Jim Petrusich, Vice President, Northwest Analytics, Manufacturing Intelligence for Intelligent Manufacturing

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

Coming Together: New Chemistry, New Science; for Industrial Innovation (TBA), Professor George M. Whitesides, Department of Chemistry & Chemical Biology, Harvard University

Check our webpages for updates at www.ifpacpat.org

Wednesday, January 22, 2014 – PM

Continuous Manufacturing
Continuous Manufacturing – I
Chairs: Vibhakar Shah, FDA and Dora 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
Experience with QbD Submissions Internationally: Future Steps with QbD & PAT
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.

Plus… Advanced Separations and Process Raman

Thursday, January 23, 2014 – PM

QbD – Quality by Design
QbD – II: Implementation of QbD for Complex Dosage Forms
Chairs: Sharmista Chatterjee, FDA, and Dora 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 – II: Process Automation/Intelligence Based Manufacturing (IbM)
Chairs: Mojgan Moshgbar, Ke Hong and Tahseen Mirza, FDA

Plus… NeSSI and Imaging

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 Dora 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 and Particle Characterization

Friday, January 24, 2014 – PM

QbD – Regulatory
QbD – III: Regulatory Discussion Session…Topic: Implementation of Question based Review (QbR) for Generic & Brand Industry
Chairs: Lawrence Yu, FDA and Ramesh Sood, 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

Additional presentations to follow… see our website for continuous updates: www.ifpacpat.org

IFPAC Posters: 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: [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