QUALIFICATION

QUALIFICATION
Product Description

Qualification activities

•Instruments Calibration 
•Validation Master Plan and Qualification Plan Issue 
•Preparation and execution of: 
 ⚬DQ, IOQ, PQ and Periodic Qualification 
 ⚬Computer System Validation (CSV) 
 ⚬Cleaning Validation •Data Integrity Assessment and Periodic Review 


 •GxP, Regulatory and EHS Risk Analysis 
 •SOP issuing and training


For strategic projects we are able to provide the following resources:

•C&Q Coordinator / Validation Manager 
•QA Specialist / Deviation and Change Control Manager 
•Technology Transfer Specialist 
•Supplier Auditor

Read more Show less

Techniconsult Group

  • IT
  • 2020
    On CPHI since
  • 100 - 249
    Employees
Company types
Consultancy
Engineering
View company profile
Categories
more categories Show less

Techniconsult Group

  • IT
  • 2020
    On CPHI since
  • 100 - 249
    Employees
Company types
Consultancy
Engineering
View company profile

More Products from Techniconsult Group (6)

  • CONSULTING & PLANNING

    Product CONSULTING & PLANNING

     •Project Management   •Site Evaluation & Selection 
     •Feasibility Study 
     •Site Master Plan 
     •Process Technology And Equipment Evaluation 
     •Gmp Consulting 
     •Contamination and Biocontamination Consulting ...
  • DESIGN & ENGINEERING

    Product DESIGN & ENGINEERING

    •Project Review •Concept Design
    •Basic Design 
    •Detail Design 
    •Facility System Integration 
    •BIM - Building Information Modeling  
    •CFD & Process Simulation
    •Procurement Assistance 
    •Follow Up
    •Value Engineering & Cost Optimizati...
  • PROCESS DESIGN

    Product PROCESS DESIGN

    Process Team Leader with more than 20 years experience in process design and start-up of pharma plants with particular reference to Biotechnology, Plasma Fractionation, API Bulk and Pharmaceutical facilities.

    Process experience covering a wide range of facilities:
    •API Bulk•Sterile ...
  • COMMISSIONING

    Product COMMISSIONING

    Commissioning activities

    •Construction Checklist •Systems Assessment, SAT/FAT witnessing 
    •Mechanical Completion and punch list management 
    •Start-Up HVAC Systems, Black & Clean Utilities 
    •Balancing and “troubleshooting” of new or existing HVAC Systems, Bl...
  • CONSTRUCTION TURNKEY SOLUTIONS

    Product CONSTRUCTION TURNKEY SOLUTIONS

    •Project Management •Design Management
    •Construction Management
    •Contract Supervision 
    •Time & Cost Control 
    •Work Supervision 
    •Follow Up 
    •BIM - Building Information Modeling 
    •Start-up & Commissioning 
    •As- built Documentation&...
  • MAINTENANCE

    Product MAINTENANCE

    Maintenance activities

    •Ordinary or extraordinary maintenance, management of manufacturing plant •Specialised maintenance of individual service and process systems 
    •Complete maintenance for system categories 
    •Global service of production units
    •Facility manag...