Quality Management Systems

Quality Systems for Pharmaceutical, Biotechnology and Medical Device Industry

Our team members have established, improved and deployed Quality Management Systems in small-. mid-, and large-sizes companies including  corporate level Quality Systems of multi national companies. They are experienced in managing and driving proactively Quality Systems and quality organizations. We support your teams in communicating with national and international authorities and Notified Bodies.

 

Quality System Improvements and Support

Re-design of Quality Management System

Implementation of Quality Management Systems

Multi-Site Integration and harmonization with global / corporate Quality Systems

Establish Quality Oversight

  • Quality Key Performance Indicators

Quality Management Systems

 

 

Implementation of core processes:

  • Management Review – Quality Oversight
  • Quality System Audits, self inspections
  • Supplier Audit ; Supplier Management
  • Documentation Control, Changes
  • Nonconformance, Deviation, OOS, CAPA,
  • Incident / Vigilance Reporting
  • Recall Management
  • Field Alert / Field Safety Notice

Laws, Regulations & Standards:

  • USA Code of Federal Regulations
    • 21 CFR Part 210/211 (cGMP)
    • 21 CFR Part 820 (cGMP)
    • 21 CFR Part 11
  • European Good Manufacturing Practice (EU GMP)
  • Good Distribution Practice (GDP)
  • GxP
  • European Medical Device Regulations
    • Directive 93/42 EEC medical devices
    • Directive 98/79 EC in vitro diagnotics medical devices
    • Directive 90/385 EEC active implantable medical devices

 

 

  • Quality System Standards and Guidlines
    • ISO 13485
    • ISO 9001
    • ICH Q10 Pharmaceuitical Quality Systems
  • Human and Animal Tissue Regualtions
  • Cosmetic Regulations
  • Sterilization of Healthcare Products
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