Conference day two


Welcome refreshments

Pat Magner

Opening remarks from the Chair

Dr Marco Schroeder

Overcoming Challenges Impacting the Encapsulation Process by Applying QbD Principles

  • Assessment of different capsule filling technologies regarding their optimal apllication area
  • Meaningful use of QbD methodologies during start of equipment design and end of qualification phase
  • Impact of critical material attributes (CMAs) on the capsule filling process, product quality and product performance
  • Standardization and optimization of critical process parameters (CPPs) for dry powder products
  • Introduction of advanced process control (APC) for productivity enhancement
Pat Magner

Can “Data mining” of PLC data ( production equipment) really add value

•    Focus on blister packaging operations
•    Is it relevant to pharma 4.0
•    Is “big data” just a buzz word to show we are up to date in our thinking or can it deliver cost effective value.
•    Short case study

Keynote Sponsor Slot

Do you have a solution that you would like to share with our audience?
Contact Edmond Rama on +44 (0) 207 092 1052 or email:

Morning refreshments


Serialisation : The Silver Bullet to protecting patents and enhancing supply chain security?

•    As fast as emerging regions are fueling pharmaceutical expansion, so does the market for counterfeit drugs. 
•    Leveraging private-public sector partnerships to drive anti-counterfeiting efforts
•    Benefits of addressing this problem with collaboration and harmonization amongst all industry and government leaders
•    The financial, social and critically important human cost of this rapidly emerging crisis
Panel discussion

Bringing it all together – The A to Z of manufacturing

This panel looks to bring experts from different areas of manufacturing together on the stage to discuss the future, best practices and ways that different faculties can work together to improve manufacturing processes.
We discuss:
•    Supply chain security
•    Patient safety 
•    Brand protection
•    Serialisation
•    Continuous manufacturing
Aaron Graham, Executive Director - Brand Safety & Security, Boehringer Ingelheim



Chaired by Zenith Technologies

Chair's opening remarks


Implementing serialisation capabilities across continents – experience and lessons learnt in the real world

•    Manufacturing site level: the importance of local workforce and change management
•    Enterprise level: hurdles to overcome when validating the solution
•    Regulations: dealing with an environment in constant evolution
•    Learning curve: be prepared to face the unexpected!

Deployment of EBRS in the pharmaceutical industry

•    Consistently meeting FDA safety & quality requirements
•    Decreasing manufacturing costs
•    Reduction of Inventory

QbD/PAT Developing a New Paradigm

QbD/PAT developing a new paradigm

Implementation of PAT Solution in Pharmaceutical Operations

•    The use of PAT sensors and Multivariate Data Analysis (MVDA) tools as key elements of the QbD Paradigm
•    PAT and MVDA tools to gain process understanding and control 
•    Feasibility study on the use of Raman technology for monitoring a mammalian cell culture process
•    Different stages needed to develop, validate and integrate a NIR solution with a compression machine in order to facilitate the Real Time Release of a solid dose form 
QbD/PAT developing a new paradigm

Establishing harmonised and relevant QRM approaches across the globe

Mr Michael Schousboe, Principal Specialist Quality Risk Management, Novo Nordisk A/S

Afternoon refreshments and close of conference

last published: 18/Nov/16 12:15 GMT