Room C Seminars

“Demonstrating CCI” for regulated package systems is best served by a “toolbox” approach incorporating multiple technologies, just as an analytical laboratory would have GCs, HPLCs, ICPs, etc, to characterize a drug product. Understanding the variables influencing method selection and implementation is crucial for regulatory success.

Qualitative process understanding tools can help with many aspects of process design, scale-up, technology transfer and manufacturing. This talk describes some of the applications in pharma and some recent developments arising from collaborative projects.

The British Standards Institution (BSI) and Poseidon have come together to create a new GDP platform to champion the development of global GDP standards, efficient quality management systems, mutually-recognised assessment schemes, supply chain best practice and the provision of professional guidance through the growing maze of GDP regulations. The Multi-Modal Compliance and Standards (MMCS) program, a  'first-of-its-kind', is providing a consensus-based foundation on which to build the common GDP standards and GDP guidance needed for the safe, efficient and compliant transportation of vital pharmaceuticals in the virus age.

The presentation will be relevant to anyone involved in the storage, distribution and quality management of medicines - manufacturers, distributors, LSPs, carriers, suppliers etc - in any capacity or transport mode.

A former MHRA inspector's experience showing different expectations of the UK Pharmaceutical industry. On the one hand, the licence holder has a desire to respond to humanitarian need. On the other hand, they meet many challenges and must still achieve compliance and exercise due diligence. Can we resolve this dilemma?

As part of our smart transformation program, we've been globally recognised by Gartner and the World Economic Forum for leading the way. Our presentation will share practical vendor agnostic examples of how you can do the same in your own operations, focusing on the main challenges identified in a smart transformation factory;
1. Identifying where to start
2. Scaling up digitisation
3. Maintaining uptime in a period of transformation
4. Empowering employees to ensure buy in

Manufacturing pharmaceuticals remains resource intensive and supply chains are increasingly affected by investment risks. To reply to this uncertainty while allowing manufacturers to access new machinery, performance oriented payment models are growing in relevance in the manufacturing world: As-a-service concepts enable manufacturers to pay for the outcome of the necessary production equipment, instead for the equipment itself. External investors own the assets and sell production output to one or multiple tenants. The foundation for these business models are IoT ready production lines. HAHN together with its partner FlexFactory are working on PoC for pharmaceutical manufacturing centered around advanced automation capabilities.