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