PAT & QbD brochure (PDF) - JMP

Conference Day One: 19th January 2010
08.50 Pharma IQ Welcome and Chairperson’s Opening
Address
09.00 Opening Presentation: EU Regulatory
Perspective of PAT Technology and Inspections
Visit www.patandqbd.com for updates
Des Makohon, Senior GMP Inspector, MHRA.
Member, PAT Team, EMEA
09.45 Case Study: Filing a QbD Submission Across the
Globe
• Outline of the product (saxagliptin, trade name
Onglyza) and the joint file process
• Highlighting the problem areas experienced
throughout the application process
• How were these challenges approached and
overcome? Analysing the feedback from the
different regulatory authorities across the globe
Gerald DiDonato, Associate Director, Global
Regulatory Sciences CMC, Bristol Myers Squibb
10.30 Process Understanding: The Key to a
Successful QbD or PAT Implementation.
To properly design quality into your product you
need to understand the relation between functional
requirements and design parameters. At the same
time, the relationship between the design parameters
and process parameters provides the basis to
properly control the manufacturing process used to
realize your product design. QbD combines both aspects,
and holds the promise of reduced time to market and
increased market share. In this session you will:
• See how Design of Experiments (DoE) allows you
to rapidly gain secure knowledge of the two
types of relationships fundamental to QbD.
• Discover how easy to use software packages,
like JMP from SAS, have made DoE a tool for
engineers, not just for statisticians.
• See several real-world examples of the use of
DoE within QbD initiatives in the pharmaceutical
and biotech industry
Dr Per Vase, Senior Specialist, Consulting, NNE
Pharmaplan
10.50 Networking Coffee Break
11.20 Multivariate Statistical Process Control: Moving
Towards Model Based Approaches
• The challenges of capturing, analysing and
monitoring with real time dynamic data
• Understanding why process dynamics and
dynamic multivariate monitoring are important to
assured pharmaceuticals development and
manufacturing
• Analysing the role of dynamics in PAT and QbD
in achieving RTR
• Increasing process understanding using
advanced PAT tools
Professor Julian Morris, Technical Director, CPACT
12.00 Ensuring Efficient QbD and PAT Implementation
PAT and QbD has left the initial phase and the
question that companies face now is how to
implement PAT and QbD in an efficient way rather
than if it is possible.
Umetrics will talk about common themes in projects
which have reached their goals within the given
timeframe and budget including:
• The importance and use of risk analysis, FMEA
• Understanding when and how to employ
multivariate methodology
• The benefits of involving QA at an early phase to
avoid delays in the implementation and
validation phase
Examples range from DoE based development
projects all the way to validated multivariate
on-line installations.
Petter Morree, Director, Online Products,
Umetrics AB
12.45 Networking Lunch Break
14.00 Case Study: Using NIR PAT Application to
Reduce Risk of Scale-Up
This case study will demonstrate how a simple PAT
application reduced the risk to critical Quality
Attributes of scaling up a Unit Dose process
Ayub Khan, Process Technologist, Napp
Pharmaceuticals
14.45 Case Study: Robust Method for the
Determination of Caffeine in Intact Tablets by
Near-infrared Spectroscopy
• Development of a method for the determination
of caffeine in intact tablets
• Effect of the sample size on the predictive
ability of the developed calibration model
• Effect of the sample variance
(variable compression force) on the predictive
ability of the developed calibration model
• Comparison between diffuse reflectance and
diffuse transmittance NIR sampling
Branko Vranic, PhD Student and Teaching Assistant,
Industrial Pharmacy Lab, University of Basel
15.30 Networking Coffee Break
16.00 Gathering Data to Support QbD
• Importance of Product Definition and Process Mapping
• Risk assessment process: Subjective vs. statistical
data, use of FMEA and Cause+Effect Matrix
• Use of measurement systems to gather data
during DoE: Measured vs. Measurement Variance
• Use of PAT to drive process control
Martin Warman, Scientific Fellow, Analytical
Development, Vertex Pharmaceuticals
16.45 Case Study: Application of QbD/PAT on a
Commercial Product: Quality by Re-Design
• The reason why we are trying to implement PAT
will also be shown to be the handling of the
incoming variability in order to deliver predefined
quality each and every time
• The utilisation of Quality Risk Management tools
for finding the Critical Process Parameters. This
includes Fishbone diagrams and FMEA’s
• Why IT and Automation infrastructure are
necessary for using MVDA during manufacturing
• Outlining the need for MVDA in manufacturing
as a confirmation of the established design
space will be described
Dr Hedinn Valthorsson, Manufacturing Manager,
Novartis
17.30 Break-Out Round Table Discussions
Participants will be able to choose between the
different roundtables and spend 45 minutes
discussing the points outlined below before
feeding back to the group
A: The Use of Lean and Six Sigma Initiatives with
PAT when Striving for Operational Excellence
Martin Warman, Scientific Fellow, Analytical
Development, Vertex Pharmaceuticals
B: Successfully Using Quality Risk Management to
Establish CQAs
Zadeo Cimarosti, Manager, Chemical Development,
GlaxoSmithKline Verona, Italy
C: Should You Build in QbD Before or After Proof of
Concept
Michael Schousboe, Senior QbD Manager,
Manufacturing Science and Quality, Novo Nordisk
D: Successfully Creating and Controlling a Secure
Design Space
Dr Barry Gujral MBA, Associate Director, Quality
Engineering, Noven Pharmaceuticals Inc.
E: How to Approach QbD in Biopharmaceuticals
Victor A. Vinci, Director, Bioprocess Operations,
Eli Lilly and Company
18.30 Chairperson’s Closing Remarks and Close of Day One
CALL: +44 (0)20 7368 9300 / 0800 652 2363 FAX: +44 (0)20 7368 9301 EMAIL: enquire@iqpc.co.uk