About this Project
OBJECTIVE
New Product Development of Medical Devices
SERVICES
PSC did multiple projects with this client for their new product development. This included:
- Design Control work including:
- Creation of design control templates to be executed by R&D team.
- Design Control Matrix review and implementation.
- Design Verification & Validation document review.
- Creation & Implementation of Design Change Control Program.
- Creation & Implementation of Design Risk Assessment Program.
- Creation of incoming good specification sheets.
- Creation & execution of equipment qualification protocols.
- Creation of process validation protocols.
- GxP auditing of manufacturing facilities to various regulations and standards.
- Quality Assurance staff augmentation at various facilities.
- Creation & implementation of process sampling program ensuring the manufacturing facilities are adhering to ANSI Z1.4.
- Rental of calibrated equipment including particle counters and temperature data loggers.
- Creation and execution of shipping validation protocols.
- Documentation GAP assessment to determine what procedures and work instructions need to be created to ensure the manufacturing facility was compliant.
Read Full Letter of Recommendation Here
EQUIPMENT USED
- Fridges
- Freezers
- Thermal Cycler
- Heat Cabinet
- Incubator
- Cleanroom
PROJECT SUCCESS
The client has been very happy with PSC’s work on the project ensuring all Toll Gate Activities were achieved on time and that the product transfer to manufacturing was successful.
