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Tuesday, August 10, 2021 9:20:37 PM
All of the development activities for the Sawston facility have been carried out under contract with Advent BioServices, who is also the operator of the facility.
The facility is now in the Performance Qualification (PQ) stage, following completion of the Design Qualification (DQ), Installation Qualification (IQ), and Operations Qualification (OQ) stages. Each of these stages has taken many months of work. In the PQ stage, practice runs are conducted for months and the performance data is collected to show that the operations meet all of the applicable regulatory requirements (sterility, quality control testing, etc.). Those data then form a major part of the application to MHRA for certification of the first phase of the facility. - March 16, 2021 PR
Ratan Dev
Data Integrity/CSV/Labware LIMS/Life Science/Validation Engineer Washington D.C. Metropolitan Area
Beltsville, Maryland, United States
Computer System Validation Engineer
Company Name: Northwest Bio therapeutics
Dates Employed: Feb 2020 – Present (Full-time)
Employment Duration:1 yr 7 mos
Location: MD, United States
Expertise in developing, generating and executing IQ, OQ, PQ protocols. Experience in conducting automated testing, traceability matrix and defect management. Experience in authoring, reviewing and auditing project documentation for validation protocols that includes Validation Master Plan (VMP), test plan and test cases, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Standard Operating procedures (SOPs), Process Design Document, Risk Classification Document and Validation Summary Report (VSR)
https://www.linkedin.com/in/ratan-dev-3493419a/ - post 394230
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