Attend
REGISTRATION & FEES
Duquesne University’s “Practical Implementation of PAT in the Pharmaceutical Manufacturing Industry” on April 26-28, 2005, in Pittsburgh, Pa.
Registration – Complete this form no later than April 8, 2005, and fax it to Duquesne University at 412.396.4660. Class size is strictly limited. Attendees will be booked on a first-come, first-served basis.
The only PAT training course offering: ■
■ ■
■
Course instruction provided by FDA regulators and scientists Hands-on training in PAT laboratory techniques Expertise of Duquesne’s nationally renowned Center for Pharmaceutical Technology, a leader in PAT method development Practical knowledge and skills that can be immediately applied towards the implementation of PAT
This event is also sponsored by Optimal Industrial Automation, Ltd., a provider of systems integration solutions to the pharmaceutical industry.
Who Should Attend? The course is structured for managers or scientists who are responsible for implementing PAT programs.
Name ____________________________________________ Job Title ___________________________________________ Company _________________________________________ Address ___________________________________________ City ______________________________________________ State _______________________ Zip Code______________
The ONLY
Hands-On Training Course in PAT Techniques
Phone ____________________________________________ E-Mail ____________________________________________
❑
I would like a non-smoking room
❑
I would like details for an additional guest and/or additional nights
❑
Other special needs _____________________________
Practical Implementation of PAT in the
Pharmaceutical Manufacturing Industry
______________________________________________ Signature _________________________________________
April 26-28, 2005
■
Pittsburgh, PA
Date ______________________________________________ For more information: www.dcpt.duq.edu Dr. Jim Drennen Associate Professor of Pharmaceutics Division Head, Pharmaceutical Sciences Phone: 412.396.6315 Fax: 412.396.4660 E-Mail: drennen@duq.edu
Fees – The $4,975 registration fee, which must be paid prior to attendance, includes all tuition and course materials, as well as three nights accommodation and meals at an historic Pittsburgh hotel. An invoice for the $4,975 registration fee will be mailed to you within one week of the receipt of your registration form.
303378 3/05 CG
Presented by
CENTER
FOR
PHARMACEUTICAL TECHNOLOGY
also sponsored by Optimal Industrial Automation, Ltd.
w ww. d c p t . d u q . e d u
SPEAKERS
AGENDA
FDA Office of Pharmaceutical Science (OPS), Center for Drug Evaluation and Research (CDER)
Monday, April 25
■ ■
Dr. Ali Afnan – Visiting Scientist Dr. Chris Watts – Staff Fellow
Duquesne University’s Center for Pharmaceutical Technology ■
■
Dr. Jim Drennen – Director of the Center, Associate Professor of Pharmaceutics, Division Head of Pharmaceutical Sciences Dr. Carl Anderson – Faculty Researcher for the Center, Assistant Professor of Pharmaceutical Sciences
Optimal Industrial Automation Ltd. ■
Dr. Gawayne Mahboubian-Jones – Product Manager for synTQ, a data management tool for PAT applications
COURSE TOPICS PAT Initiatives – Discuss the latest PAT trends and strategies with regulatory and scientific experts.
7:00-9:00 p.m.
Registration and Coffee
9:30-9:45 a.m.
Introduction Jim Drennen & Carl Anderson
9:45-10:30 a.m.
■ ■
Implementation Jim Drennen
■
Instrumentation – Conduct practical experimentation using modern PAT instrumentation and techniques. Chemometrics – Use multivariate analysis techniques to achieve process understanding from unit operations data.
PROCESS EXPERIMENTS Drying – Tray drying is a common practice in many pharmaceutical companies and it is often difficult to control. Thermal data and NIR Sensors are used to monitor and control a lab-scale version of this process, enhancing the quality and reproducibility of its output.
■
9:00-10:00 a.m. Potential Control Strategies Carl Anderson & Gawayne Mahboubian-Jones ■ ■
11:30 a.m.-Noon ■ ■ ■ ■ ■ ■
Risk Analysis Gawayne Mahboubian-Jones
Types of risk analysis Techniques PAT during process design PAT for existing processes Identification of potential critical control parameters Examples
Noon-1:00 p.m. ■ ■
■ ■ ■ ■ ■
Expected outcomes Screening/feasibility Design structure Variable selection Parameter significance testing Study type Data analysis Significance levels
Experimental Design Carl Anderson & Ali Afnan
Review of measurement technologies Sampling Process understanding from multivariate analysis Process modeling
10:00-10:30 a.m.
Break
10:30-11:30 a.m.
Implementation of Control Strategies Gawayne Mahboubian-Jones
■ ■ ■ ■
Systems integration Data management Control strategies Examples
11:30 a.m.-12:30 p.m. ■ ■
■
Blending – Controlling the blending process can provide improved manufacturing efficiency and consistent uniformity for solid oral dosage forms. An on-board NIR sensor is used to monitor and control a lab-scale bin blender.
Risk analysis Experimental design Control strategies Model development and transfer Process sampling Information management
Blending (group one) Drying (group two)
Wednesday, April 27
■
11:00-11:30 a.m.
■
Lab Exercises
■
What is PAT Why is PAT necessary What benefits will industry/agency/public achieve with PAT Break
■
Data Management – Gain hands-on experience with the latest data analysis management techniques.
PAT Overview Chris Watts
10:30-11:00 a.m.
■
2:00-5:00 p.m. ■
9:00-9:30 a.m.
■
Lunch
■
Tuesday, April 26
■
Continuous Validation – Learn the new philosophy for continuous validation of pharmaceutical systems.
Welcome Reception
1:00-2:00 p.m.
■ ■ ■ ■ ■
Achieving process targets Continuous learning and improvement Assessment of process understanding Control strategies Regulatory submission Documentation/feedback Examples
12:30-1:30 p.m. 1:30-5:00 p.m. ■ ■
Optimization and Review Chris Watts/Ali Afnan
Lunch Lab Exercises
Blending (group two) Drying (group one)
Thursday, April 28 9:00-11:30 a.m. 11:30 a.m.-1:00 p.m.
Review and Discussion of Experimental Work Lunch