09.00 Chairperson’s Welcome and Opening Address

Chair:

Julian Morris
Technical Director
Centre for Process Analytics and Control Technology

09.10 Realising the Practical Advantages of PAT and QbD: from R&D to Manufacturing

• Clarifying the need to implement in line monitoring during R&D stages and how to follow through to manufacturing.
• Explaining where in the pharma process the benefits of PAT and QbD are seen
• Challenges still faced in implementing PAT and QbD in R&D as well as manufacturing and how to overcome these

Gawayne Mahboubian - Jones
Program Manager QbD
Phillip Morris International

09.50 Case Study: How Hovione is Embracing the PAT/QbD Paradigm: the Excellence for Developing and Manufacturing program

• How PAT is supported at Hovione, from the perspective of a CMO
• The case study of an already RA approved process developed under a QbD paradigm

Nuno Matos
PAT specialist
Hovione

10.30 Realising How the Key Principles of PAT can Reduce Business Risk: Using Case Studies to Highlight the Benefits

• How data collection and analysis leads to process understanding
• How the reduction of waste can be achieved .
• Understanding the system in which your process is involved
• How this approach can be embedded in your organisation

Tom Cochrane
Business Process Development Manager
Napp Pharmaceutical Group

11.40 Break‐Out Round Table Discussions

1. Realising the Financial Benefits of PAT and QbD and How to Reduce Business Risk

Facilitator:

Tom Cochrane
Business Process Development Manager
Napp Pharmaceutical Group

2. Assessing the Guidelines for Risk Management

Facilitator:

Gawayne Mahboubian Jones
Program Manager QbD
Phillip Morris International

3. The Application of PAT and QbD for Biopharmaceuticals

Facilitator:

Ali Afnan
President
Step Change Pharma

12.20 Advances in Sampling and Measurement Science to Achieve Process Understanding for the Purpose of Developing Models for Effective Process Control

• The use of micro‐reactors with the NeSSI™ sampling platform
• FDA interest in demonstrating approaches to feedback process control
• Selected measurement tools to characterise the design space
• Incorporating data handling ideas to show the value of data fusion

Mel Koch
Marketing Director
Centre for Process Analysis and Control

14.30 Technology Spotlight

• A demonstration of the latest PAT and QbD technologies from a leading industry service provider

This session is reserved for a leading provider of PAT and QbD Technology, if you think your product would be of interest to the delegation, get in touch on +44 207 368 9300 or email sponsorship@iqpc.co.uk

15.10 The Benefits of using Quality Risk Management in the Product Lifecycle and Performing Risk Assessment

• The challenges of implementing Quality Risk Management
• Overcoming the hurdles presented
• Showcasing examples of different applications and demonstrating successful cases

Mette Kraemmer Hansen
Quality Expert and Quality Management Specialist
Novo Nordisk

16.20 Proposal for Implementing a QbD Strategy With Regards to Tablet Film‐Coating in Pans: Selection of Parameters to be Studied and Resulting Methodology

• Theoretical approach for pan coating process understanding and selection of factors to focus on
• Proposal for a QbD strategy highlighting these parameters
• Case study: lab scale process optimization and pilot scale trials

Marie Calame
Pharmaceutical Engineering Technical Manager
Sanofi Aventis

17.00 Case Study: Smart Process Analytical Technologies for Rapid Scale‐up and Control

• Variability challenges facing the robust implementation of PAT in R&D and production and how to overcome these challenges.
• Key challenges in rapid prototyping and rapid scale of new entities
• How to develop robust PAT calibrations and Models from minimal data and few batch runs
• Successfully applying PAT tools and smart chemometrics for robust applications
• Industrial applications from R&D and production

Julian Morris
Technical Director
Centre for Process Analytics and Control Technology

17.40 Chairperson’s Closing Remarks and End of Conference