08.50 Pharma IQ Welcome And Chairperson’s Opening Address

09.00 Opening Presentation: EU Regulatory Perspective Of PAT Technology And Inspections

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

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

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

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

18.30 Chairperson’s Closing Remarks And Close Of Day One