BCMPA Seminars

Having worked within the Pharmaceutical field for over a quarter of a century AI is by far the biggest step change that I have seen in terms of a single technology’s ability to improve the Quality of a process / product and generate insights from data.

Appraiseye, a partner company of Central Pharma Contract Packing has developed a suite of templates that enables AI’s rapid deployment within a host of operational, production, research and clinical environments to improve Quality and Efficiency in a way never seen before. Appraiseye’s application of AI removes the fiction from science fiction and provides organisations a true competitive advantage.

A draft guidance of Computer Software Assurance (CSA) for Production and Quality System Software has been recently issued by the FDA. This new guidance, together with the second edition of the GAMP 5 guide, have shifted the emphasis away from indiscriminate scripted testing and documentation, towards more critical thinking and a risk based testing strategy. But CSA goes beyond the deployment of a particular methodology for testing strategy. It is more about a way of thinking about the management of computerized system, moving further towards a risk-based approach in all the aspects of their management.
Now that the new recommendations have been established, this practical session will cover the steps companies should take to align themselves optimally with the new CSA approach and take advantage of the opportunity to improve their software implementation and validation processes, spending less time on the mechanical aspects and getting better results.

This presentation will cover the Grand Challenge 2 Project (PACE – Pharmaceutical Automation for Clinical Excellence) which will be delivered as POC in 2 months’ time. The key components of this project are:

• • • The modular design of PACE which allows, multiple drugs to be manufactured and packaged in the same facility without cross-contamination.
    • Layers of control from PLC to SCADA, to MES and finally there is a Real-time Qualified Person (QP) release dashboard which has been created to accelerate release of drug product.

A comprehensive look at how your choice of primary packaging can impact time to market.

We start by covering the minimum requirements for primary parenteral drug packaging – ensuring that the packaging that comes into direct contact with your formulation meets standards set out in the EP, JP and USP.

From there we talk about specific challenges faced by those in drug development, including problems with freeze drying, formulation sensitivities, conforming to the principles of Annex 1, and the part packaging plays in both the problem and the solution.

We provide a guide to the possible solutions, all presented in an informative presentation.