SAZA Consulting


Process based services

  • Risk Management process and file review
  • Sterilization and packaging validation reports review
  • Special processes validation reports review


  • Liaise and coordinate with NB and regulatory agencies through acting as company management representative
  • Assist in preparing and driving company quality objectives and goals utilizing process approach module
  • Review and fine-tune company quality policies to facilitate establishment of quality objectives
  • Support management review efforts

Supplier management

  • Perform initial qualification efforts
  • Audit and continually review supplier performance

Correction and preventive action management

  • Respond to nonconformances / deficiencies with assistance in identification of root cause analysis
  • Issue and effective action plans for major nonconformances
  • Assistance in CAPA review meeting
  • CAPA verification and effectiveness check

Design and development efforts

  • General design plan assessment
  • Design risk based approach (design failure mode and effect analysis)
  • Independent D&D review
  • Assess design changes
  • Review and analyze design transfer activities
  • Change notice package review prior to notified body and/or regulatory agency submission

Phone: 301-339-3448

Address: 2563 Windmill View Rd, El Cajon, CA 92020

SAZA Consulting © 2023