Agile Validation Experience (2 days) - Breda, The NetherlandsDescription: www.rescop.com/agile-v.....8-nl/
Golden Tulip Keyser Breda, Keizerstraat 5, 4811HL Breda, The Netherlands
Through our Quality Engineering services we can support the full life cycle of your facilities. From concept phase through design and construction until commissioning, our consultants offer you a risk-based approach to build or revise GMP compliant facilities. Our consultants will demonstrate compliance throughout each project phase, including retirement and decommissioning.
Co-write the User Requirement Specifications in cooperation with the business partners (users)
Develop proces flow diagrams
Create facility layouts and PI&D's
Draw up personnel and material and waste flow diagrams
Create and maintain equipment and utility requirements.
Project planning and cost budget estimation
Create contracts (SLA) for vendors and suppliers based on the design concept
Perform Impact Assessment (Direct or In-direct Impact)
Perform Critically Assessment
Develop the project validation plan (VMP en SMP)
Write Functional design specifications, P&ID's, Cleanroom and equipment specifications etc.
Support purchasing equipment and services
Review vendor/supplier documentation (FAT and SAT)
Manage, supervise and inspect construction activities
Monitor project progress (ensure compliance during project)
Quality is integrated from the earliest stages of the project
Through FAT and SAT to commissioning
Qualification by IQ (Installation Qualification), OQ (Operational Qualification) and PQ (Performance Qualification)
Rescop is active in the following industries