Process Analytical Technology Seminar : PAT and QbD Implementation

Process Analytical Technology Seminar Series

Process Analytical Technology (PAT) and Quality by Design (QbD) Implementation

Process Analytical Technology (PAT) and Quality by Design (QbD) have been buzz words in the pharmaceutical and biopharmaceutical industries for a number of years now and based on the literature and guidance documents available,

these initiatives are gaining real momentum. Fundamental to these initiatives are the basics of Multivariate Analysis and Design of Experiments. This seminar outlines some of the practical issues regarding the implementation of PAT/QbD and looks at the following topics.

The pragmatic use of guidance to enable, not hinder, progress
The multivariate nature of Design Space as stated in ICH Q8
Historical vs. Designed data, challenges and opportunities
Principal Component Analysis, the workhorse of multivariate methods
Variability reduction and the use of Regression Modelling: The Concept of Smart Manufacturing and MAFSS
Fundamentals of Multivariate Statistical Process Control (MSPC)
Combining information from unit processes to form a process model.The HHL Model
Putting it all On-line for real time analysis and regulatory guidance allowing such systems
Question and Answers

Innovative approaches to Pharmaceutical & Biopharmaceutical Development and Manufacturing

Speaker:
Brad Swarbrick
Pharmaceutical Business Development Manager
CAMO Software

London, UK January 27

Venue:

The School of Pharmacy
University of London
29-39 Brunswick Square
London WC1N 1AX, United Kingdom

Tel: +44 (0)20 7753 5800
Fax: +44 (0)20 7753 5829	Directions

Seminar room: Lecture Theatre 212b on the 2nd floor

Agenda:

9:30 - 10:00

Registration and Coffee

10:00 - 10:15

Introduction
(Kenneth Olafsson,
Account Manager,
CAMO Software)

10:15 - 11:45

Process Sampling - the missing link in PAT
(Kim H. Esbensen Ph.d.
Professor, ACABS)

11:45 - 12:00

Coffee Break

12:00 -12:30

The Increasing Need of Multivariate Analysis for Process Understanding and Control
(Brad Swarbrick, Pharmaceutical Business Development Manager,
CAMO software) – Part 1

12:30 - 13:30

Lunch

13:30 - 14:15

Enhanced Process Performance Monitoring through the Combination of Spectroscopic and Process Data
(Julian Morris)

14:15 - 14:30

Coffee Break

14:30 - 15:30

The Increasing Need of Multivariate Analysis for Process Understanding and Control
(Brad Swarbrick) - Part 2

15:30 - 16:00

Wrap up

16:00

End

Frankfurt, Germany February 04

Venue:
Johann Wolfgang Goethe-Universität Frankfurt Campus Bockenheim Sozialzentrum/Mensa Konferenzraum III Bockenheimer Landstraße 133, D-60325 Frankfurt Germany

Agenda:

8:30 - 9:00		Registration and Coffee
9:00 - 9:10		Introduction
9:10 - 12:15 (with 15 minutes coffee break)		The Increasing Need of Multivariate Analysis for Process Understanding and Control (Brad Swarbrick, Pharmaceutical Business Development Manager, CAMO Software)
12:15 - 13:15		Lunch
13:15 - 14:45		Process Sampling - the missing link in PAT (Kim H. Esbensen Ph.d. Professor, ACABS)
14:45 - 15:00		Coffee break
15:00 - 15:30		A Flexible NIR-System - From Lab to Process (Polytec GmbH)
15:30 - 15:45		Wrap up
15:45		End

Paris, France February 06

Venue
16 Avenue du Québec SILIC 765 91963 Courtaboeuf Cedex

Agenda

9:00 - 9:15		Accueil
9:15 - 9:30		Introduction Thermo Electron et CAMO
9:30 - 11:00		The Increasing Need of Multivariate Analysis for Process Understanding and Control (Brad Swarbrick, Pharmaceutical Business Development Manager, Camo Software)
11:00 - 11:15		Pause café
11:15 - 12:00		Extraire efficacement les informations des analyses de contrôle qualité avec les plans d’expériences et les méthodes multivariées.
12:00 - 12:20		Suivi en ligne de séchage et granulation (Thermo Electron)
12:20 - 13:45		Déjeuner
13:45 - 14:15		Détermination de la teneur en eau de produit pharmaceutique en ligne par spectroscopie proche infrarouge(Dr Yves Roggo, F. Hoffman Laroche)
14:15 - 14:35		Suivi en ligne de l’homogénéité des mélanges de poudres(Thermo Electron)
14:35 - 15:00		Dosage de principe actif dans produits finis .Uniformité de teneur (SANOFI ou Thermo)
15:00 - 15:15		XX(UV ou IR Thermo)
15:15 - 15:30		Validation et Aspects réglementaires(SFSTP)
15:30 - 16:00		Discussion et clôture du séminaire
16:00		Fin

+Copenhagen, Denmark February 12

+Singapore April 20

Venue:
GEA-NUS PP Res Lab, National University of Singapore, 21 Lower Kent Ridge Road, Singapore 119077. www.nus.edu.sg

Agenda:

08:50 - 09:00		Registration
09:00 - 10:00		Session I (Brad Swarbrick, Pharmaceutical Business Development Manager, CAMO software)
10:00 - 10:30		Coffee Break
10:30 - 12:00		Session II (Brad Swarbrick)
12:00 - 13:00		Lunch
13:00 - 14:00		Q&A
14:00		End

more details...

All aspects will be discussed along with CAMO Software solutions (both old and new) for addressing these topics. Some strategic alliances with process monitoring technology and quality system vendors will be discussed. PAT and QbD, now more than ever, represents the future of global pharmaceutical development and manufacturing. Having the right systems in place with the right data analysis tools will mean the difference between a successful implementation and failure.

in association with GEA-NUS