プロフィール詳細

プロジェクトを作成

★★★★★

☆☆☆☆☆

★★★★★

☆☆☆☆☆

Dr. Seval K.に依頼

Turkey

Global Life Science Advisor – Quality Assurance & Controls - Regulatory Affairs - R&D - Production - Clinical Affairs

プロフィール概要

Quality Assurance , Validation Planning and Reporting , Medical Device Clinical Study Design and Reporting by CER PSUR and else. , FDA Registeration and US Agent Services , Regulatory Compliance and New Product Research and Development through its clinical data and Process Improvent of the Production Lines and Efficiency-Focused Cost-Reduction Engineering

専門分野

• ☆ Medical Devices
• ☆ Medical Device Development
• ☆ Medical Device Validation
• ☆ Medical Device Regulatory Consulting
• ☆ European Medical Device Regulation (MDR)
• ☆ ISO 13485
• ☆ ISO 14971
• ☆ EU In vitro Diagnostic Regulation (IVDR) Compliance
• ☆ Clinical Trials
• ☆ Regulatory Affairs

サービス

• Writing
• Research
• Consulting
• Product Development

Writing Clinical Trial Documentation, Medical Writing, Technical Writing

Research Gap Analysis, Scientific and Technical Research

Consulting Legal Consulting, Operations Consulting, Scientific and Technical Consulting, Regulatory Consulting, Manufacturing Consulting

Product Development Formulation, Product Validation, Manufacturing, Quality Assurance & Control (QA/QC), Product Compliance

職務経験

Consultant

Services of Engineering Validation & Consultancy

6月 2023 - 現在

学歴

Chemistry PhD

Bolu Abant Izzet Baysal University

2月 2020 - 1月 2026

認定資格

• Fall School on Programmable Photonic Quantum Computers

  TUBITAK RESEARCH INSTITUTE FOR FUNDAMENTAL SCIENCES

  9月 2025 - 現在

• ISO 13485 Internal Assessor

  Inovation Consultancy

  1月 2025 - 現在

• IATF 16949 Automotive Quality Management System (APQP-PPAР-FMEA-SPC-MSA)

  Istanbul Quality Academy

  11月 2024 - 現在

• Effectively Managing Clinical Data Collection Using cost-Sensitive Methods and PMCF

  Qserve Clinical B.V

  9月 2024 - 現在

• New Period Medical Device Market Launch Processes

  EUMed

  5月 2023 - 現在

• Clinical evaluation under MDR with case studies from the notified body GMED

  Eclevar

  5月 2023 - 現在

• HPLC-GC

  Perkin Elmer

  4月 2023 - 現在

• FDA Regiateration

  IKMIB by Tania A. Martinez FDA Member

  10月 2022 - 現在

• UKCA Marking (Certification) for Medical Devices

  Tumdef

  9月 2022 - 現在

• MDR

  NB - Szutest

  5月 2022 - 現在

• Responsible Manager

  TITCK

  4月 2022 - 現在

• Sales and Promotion Responsible

  TITCK

  4月 2022 - 現在

• Clinical Studies Responsible

  TITCK

  4月 2022 - 現在

• Clinical Studies for Medical Devices

  TITCK

  4月 2022 - 現在

• MDR : Medical Device Technical Documentation Preparation Training

  EUMed

  3月 2022 - 現在

• Minitab and Statistics

  Sigma Center Kalite ve Verimlilik Danışmanlığı

  12月 2021 - 現在

• Plastics Production

  Metin Bilgili Consultancy

  12月 2021 - 現在

• ISO 27001 Information Assurance Standards

  Bimed

  12月 2021 - 現在

• Production Process Validation

  AdviQual

  10月 2021 - 現在

• Microbiological Environment Control

  Bıçakcılar Medical Devices

  10月 2021 - 現在

• Controlling of Designing Steps

  AdviQual

  10月 2021 - 現在

• SAP Success Factors & SAP Success Factors Personnel Affairs Module

  Bimed

  8月 2021 - 現在

• Corporate Awareness and Effective Communication

  Bimed

  5月 2021 - 現在

• Packaging Validation ISO 11607-1, ISO 11607-2, ISO 868-5

  AdviQual

  5月 2021 - 現在

• ISO 13485: Quality Management for Medical Devices

  Kiwa

  3月 2021 - 現在

• Workdays and Periodic Health Education

  Bimed

  3月 2021 - 現在

• Usability

  Adviqual - Tümdef

  1月 2021 - 現在

• Cleaning Validation

  Ecolab

  1月 2018 - 現在

• Pharmaceutical Production, Microbiology, QA, QC, Hygyene,Calibration,Validation,Water Puriffication HVAC, GxP, Health and Safety etc...

  İdol Pharmaceutical

  5月 2017 - 現在

• Chemistry Teaching

  Iskur On-the-Job Training Program

  8月 2016 - 現在

• 5th National Inorganic Chemistry Congress

  Mersin Univercity

  4月 2015 - 現在

• Nanotechnology: Research and Development

  Lithuanian Academy of Sciences

  1月 2014 - 現在

• Diction Training

  Elginkan Foundation

  10月 2013 - 現在

• Speed Reading and Memory Techniques

  Elginkan Foundation

  9月 2013 - 現在

• Effective Communication

  CPA Consultancy

  2月 2013 - 現在

• ISO 9001 Internal Assessor

  CPA Consultancy

  2月 2013 - 現在

• Paint Production Management

  Chemists Association

  1月 2011 - 現在

• How to Make Money from Foreign Trade

  İzgören - Akin

  10月 2007 - 現在