Enjoy a unique opportunity to interact with regulators and researchers in this rapidly emerging field. Gain first hand knowledge of the utility of PAT tools using laboratory-scale pharmaceutical manufacturing equipment.
PAT - The future of Pharmaceutical Manufacturing
Duquesne University in association with
Optimal Industrial Automation Present
Booking Details Name
Practical Implementation of PAT in the Pharmaceutical Manufacturing Industry
Position Company Social Security # Address
26th - 28th April 2005 Location - Omni William Penn Hotel –Pittsburgh, PA
City PostCode Zip
A three day residential course introducing the theory and techniques associated with the FDA’s Process Analytical Technology initiative
Country Email
Speakers: Dr. Ali Afnan - Visiting Scientist – U.S. Food and Drug Administration (FDA),
Payment Details By Invoice $5000
Please invoice my company
✓
Note: payment must be received prior to attendance. Order No. Options I would like a non smoking room ✓ I would like details for an additional guest and/or additional nights. ✓ Other special needs Sign and date Dr. J.K. Drennen III Dept. Pharmaceutical Sciences, Duquesne Univeristy, 600 Forbes Avenue, Pittsburgh, PA 15282 USA Email: drennen@duq.edu, Fax: 412.396.4660, Phone: 412.396.6315.
Office of Pharmaceutical Science (OFS), Center for Drug Evaluation and Research (CDER)
Dr. Chris Watts -
Staff Fellow - U.S. Food and Drug Administration (FDA), Office of Pharmaceutical Science (OFS), Center for Drug Evaluation and Research (CDER)
Dr Jim Drennen - Associate Professor of Pharmaceutics and Head, Pharmaceutical Sciences Division - Duquesne University Director - Duquesne University Center for Pharmaceutical Technology (DCPT) Dr Carl Anderson - Assistant Professor of Pharmaceutical Sciences - Duquesne University Faculty Researcher - Duquesne University Center for Pharmaceutical Technology (DCPT)
Dr Gawayne Mahboubian-Jones - synTQ Product Manager, Optimal Industrial Automation Ltd.
Fees Course Fee $5,000 Fee Includes: All tuition and course material. Three nights accommodation at the historic William Penn Hotel including meals.
How to Book Please use the enclosed booking form or apply direct to: Dr James K Drennen, III Duquesne University Email: drennen@duq.edu Tel: 412-396-6315
or contact: Optimal Industrial Automation Ltd Goodrich Close Westerleigh Business Park Yate Bristol BS37 5YT Tel: 01 454 333222
Course Objectives
Program
PAT Initiatives
Monday 25th April Welcome Reception
Discuss the current thinking around PAT issues with regulatory and scientific experts.
The Validation Process Learn about the new philosophy for validation of pharmaceutical systems.
Data Management Gain practical experience with leading edge data management techniques.
Instrumentation Conduct practical experimentation using modern PAT instrumentation
Email: enquiries@optimal-ltd.co.uk and techniques.
Duquesne University
Chemometrics
Duquesne University faculty have been working at the forefront of Process Analytical Technology through its inception and work closely with the pharmaceutical industry. They have practical experience with implementation of PAT methods in manufacturing facilities.
Use multivariate analysis techniques to achieve process
Optimal Industrial Automation Ltd Optimal has a long history of automation systems integration within the pharmaceutical industry. They have carried out major projects for most of the large manufacturers and have an enviable reputation for the delivery and support of high quality systems around the world. Optimal has developed a data management tool, synTQ, for use in PAT applications. During its development, Optimal has been closely involved with the PAT initiative and are represented on the ASTM E55 PAT Steering committee.
understanding from unit operations data.
Experiments Drying Process Tray drying is a common practice in many pharma companies and is often difficult to control. NIR
This course gives a unique insight into techniques and theory behind the implementation of Process Analytical Technology in the Pharmaceutical Manufacturing arena. It is being presented by Duquesne University of Pittsburgh USA in association with Optimal Industrial Automation of Bristol UK. The basic structure of the course will be discussions of theory and application in the morning sessions, followed by practical experimental sessions in the afternoon. Delegates will have the opportunity to collect and analyse real data from laboratory scale pharmaceutical processing equipment. The concepts to be explored during the course are derived from the recent FDA Guidance. PAT—A framework for Innovative Pharmaceutical Development, Manufacturing and Quality Assurance— September 2004PAT
Sensors are used to monitor and control a lab scale version of this process, enhancing the quality and reproducibility of its output. Blending Process Controlling the endpoint of blending processes can provide improved content uniformity for solid oral dosage forms. An on-board NIR sensor is used to monitor and control a lab-scale bin blender.
Please note If you would like to book extra nights accommodation for persons not attending the course we would be pleased to arrange this for you.
Tuesday 26th April 9.00 – 9.30 Registration and Coffee 9.30 – 9.45 Introduction Jim Drennen/Carl Anderson Course Objectives Course structure 9.45 – 10.30 PAT Overview Chris Watts Regulatory Perspective of PAT • What is PAT • Why is PAT necessary • What benefits will industry/ agency/public achieve with PAT 10.30 - 11.00 Coffee 11.00 – 11.30 Implementation Jim Drennen Key Elements for PAT implementation • Risk analysis • Experimental design • Control strategies • Model development and transfer • Process sampling • Information management 11.30 – 12.00 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
12.00 – 13.00 Experimental Design Carl Anderson/Ali Afnan • Expected Outcomes • Screening/Feasibility • Design Structure • Variable Selection • Parameter Significance Testing • Study Type • Data Analysis • Significance Levels 13.00 – 14.00 Lunch 14.00 – 17.00 Lab Exercise Day 1
Blending (group 1) Drying (group 2) Wednesday 27th April 9.00 – 10.00 Potential Control Strategies Carl Anderson /Gawayne MahboubianJones • Review of Measurement Technologies • Sampling • Process understanding from multivariate analysis • Process modelling 10.00 – 10.30 Coffee 10.30 – 11.30 Implementation of Control Strategies Gawayne Mahboubian-Jones • Systems Integration • Data Management • Control Strategies • Examples
11.30 – 12.30 Optimization and Review Chris Watts/Ali Afnan • Achieving Process Targets • Continuous Learning and Improvement • Assessment of Process Understanding • Control Strategies • Regulatory Submission • Documentation/Feedback • Examples 12.30 – 13.30 Lunch 13.30 – 17.00 Lab Exercise Day 2 Blending (group 2) Drying (group 1)
Thursday 28th April 9.00 – 11.30 Review and Discussion of Experimental Work 11.30 – 13.00 Lunch 13.00 Close Note – Details of the Program are subject to change