FDA Quality System Regulation Consulting and Training

Services for Bio-Medical and Pharmaceutical Industries

Techlogic, Inc. provides a complete “A to Z” offering of implementation services for the bio-medical and pharmaceutical industries.   Specific consulting and training services include: 

  • Baseline assessment (gap analysis)
  • Building and facilities audits
  • Quality steering team (committee) set-up, implementation, and coordination
  • Quality System implementation planning, with detailed timelines
  • Management and employee quality systems overview training
  • Documentation training
  • Internal auditor training (quality system, product, process and performance)
  • Detailed training for the quality steering team (12 sessions)
  • Detailed quality systems training for employees (six sessions), includes GMP’s
  • Management review meeting planning and coordination
  • Statistical analysis identification, planning, training, and coordination
  • Monitoring and measurement of processes training
  • Monitoring and measurement of product training
  • Customer satisfaction system definition, implementation, and coordination
  • Process validation training
  • Flowcharting training and consulting (micro and macro) to interconnect processes (organizational and functional levels)
  • Product verification and validation training (hardware, software, firmware, and drivers)
  • Root cause analysis training
  • Preventive action definition, implementation, and coordination
  • Pre-assessment audit, with full reporting
  • On-site assistance during the registration final audit
  • Assistance in responding to audit nonconformities (if any)
  • Sterilization, bio-burden, and environmental monitoring training and consulting
  • Labels and Labeling training and consulting
  • Hazard / Risk Analysis, P/D FMEA, and LCA consulting and training
  • Essential requirements consulting and training
  • DMR, DHF, and DHR consulting and training
  • Clinical and Regulatory Affairs consulting and training
  • Strategy definition and planning for FDA Compliance
  • Premarket Notification Preparation (510(k)/PMA)
  • Clinical Trials (IDE/PMA/NDA)
  • HACCP Consulting and training