Design transfer – trouble-free and meeting regulatory requirements
From my own experience as project leader Design Transfer in the pharmaceutical industry I know, that the transfer of a manufacturing site, the so called Design Transfer requires more than just a physical transfer of equipment. Regulatory requirements, GMP regulations and national legal guidelines increase the complexity of the project. As project leader I am responsible satisfying and fulfilling all needs and requirements of all involved parties and stakeholders.
From an apparently simple transfer of some production steps to the transfer of the whole production chain the complexity of a Design Transfer varies. The project is an additional task besides the daily business, which already by itself fills up the organisation completely. So conflicts arise and complex projects are in danger to turn out to be a slot machine, with the time running out at the same time.
For projects of this kind an experienced person is required. Exceeding my professional experience I gained enough conflict and communication skills, to solve problems caused by misunderstanding and miscommunication between parties.
For Design Transfer for Pharmaceuticals and Medical devices I offer:
- International operative project management (German/English)
- Preparation of business cases for the executive management
- GMP complying transfer with regard to regulatory requirements and national legislation
- CMOs (Contract Manufacturing Site) Selection
- Transfer of development products into commercial production