Computerised Systems Validation
Validation makes good business sense: PharmaTraining Services offer training in compu...
In the early days of pharmaceutical chemistry R&D it was believed that research was the primary activity and development was a simple follow on. Consequently all the best emerging talent was directed into research programmes. However it eventually became apparent that the quality of development work had an enormous impact on realising the best outcome of the new discoveries. Improved profitability fed back into research and this synergy created the most successful pharmaceutical companies worldwide.
As regulatory requirements in Health, Safety, Environment and Quality increased, development chemists had to increase awareness of these as well as their core chemistry skills. So chemical development became a multidisciplinary activity and the worth of good development became apparent for the success and indeed the survival of the business.
New chemistry graduates emerge every year trained in chemistry alone. Consequently they need extensive additional training before taking responsibility for a project. This 2 day course addresses these needs and aims to give an overview of the life cycle of pharmaceutical chemical development. This includes continuous improvement and technology transfer to low cost economies as the active pharmaceutical ingredient approaches generic status and the economic dynamics change abruptly.
This course can be provided in-house or specific items such as the vital area of process safety assessment can be expanded on in more detail on request.
Speaker: Dr Ron Scott, Director of Pharmaceutical Development Services. Ron is an expert in all aspects of the development of chemical processes and manufacture of APIs. During a 25 year career he has worked in leading contract manufacture and contract R & D organisations including Oxford Asymmetry and Almac Sciences where he held senior management positions in technical operations up tp Vice President level.
Ron specialises in the design and optimisation of robust and economical chemical processes for the supply of new chemical entities for clinical development and subsequent commercial manufacture. A particular niche area of expertise is the design and safe use of facilities for handling highly potent active pharmaceutical ingredients, typically for oncology applications.