Alpay Çalişkan

Alpay Çalişkan Email and Phone Number

Founder and Quality and Validation Consultant @ QVAC Validation Consulting
Turkey
Alpay Çalişkan's Location
Türkiye, Turkey
About Alpay Çalişkan

*More than 20 years of quality assurance, production, laboratory and engineering experience in the pharmaceutical industry.* GLP&GMP, ISO13485 Quality System Management Consulting* We perform the Validation and Qualification activities for Sterile, Non-sterile Production, Utility and Laboratory equipment & system and software * Validation of Computerized System according to FDA, ISO13485, ISO80002, IEC/EN62304, GMP, 21 CFR Part11, GAMP 5,EU Annex11-15,PICS regulations. * Data integrity, GAP Analyse* Software Validation (SAP, BMS,QDMS, WMS,ERP, SCADA,PLC, EXCEL and specific sw)* Cleanroom Qualification* Periodic Requalification & Reevaluation* Prufied System, WFI system, Liquid and gases pipeline qualifications* Engineering Qualification and Calibration management system improvement* Engineering & laboratory inhouse calibration and cost saving activities* Project management* Process Validation* Training

Alpay Çalişkan's Current Company Details
QVAC Validation Consulting

Qvac Validation Consulting

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Founder and Quality and Validation Consultant
Turkey
Website:
qv-ac.com
Employees:
5
Alpay Çalişkan Work Experience Details
  • Qvac Validation Consulting
    Founder And Quality And Validation Consultant
    Qvac Validation Consulting
    Turkey
    View
  • Qvac Validation Consulting
    Founder / Quality & Validation Consultant
    Qvac Validation Consulting May 2018 - Present
    İstanbul
    View

Alpay Çalişkan Skills

Validation Chromatography Sap 21 Cfr Part 11 Csv V&v Testing Gamp Computer System Validation Validation Master Plans Instrument Validation Trackwise Capas Gxp Dissolution Gmp Sop Pharmaceutical Industry Quality Control Calibration Change Control Gas Chromatography Laboratory Quality System R&d Pharmaceutics Hplc Capa U.s. Food And Drug Administration Research And Development Standard Operating Procedure Manufacturing Hvac Utility Prufied Water System Opex Capex Risk Assesment

Alpay Çalişkan Education Details

  • Ankara University
    Ankara University

Frequently Asked Questions about Alpay Çalişkan

What company does Alpay Çalişkan work for?

Alpay Çalişkan works for Qvac Validation Consulting

What is Alpay Çalişkan's role at the current company?

Alpay Çalişkan's current role is Founder and Quality and Validation Consultant.

What schools did Alpay Çalişkan attend?

Alpay Çalişkan attended Ankara University.

What are some of Alpay Çalişkan's interests?

Alpay Çalişkan has interest in Chromatography And Snowboard, Discovery Channel, Mechanical And Electronic Technology.

What skills is Alpay Çalişkan known for?

Alpay Çalişkan has skills like Validation, Chromatography, Sap, 21 Cfr Part 11, Csv, V&v, Testing, Gamp, Computer System Validation, Validation Master Plans, Instrument Validation, Trackwise.

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