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 GMPs

        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