ISO-13485:2003 Quality Systems 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

        Registrar selection

        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)

        Root cause analysis (RCA) training

        IQ/OQ/PQ and process validation training

        Software validation training

        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

        Flowcharting training and consulting (micro and macro) to interconnect processes (organizational and functional levels)

        Product verification and validation training (hardware, software, firmware, and drivers)

        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 and FDA 483’s

        Sterilization, bio-burden, and environmental monitoring training and consulting

        Labels and labeling training and consulting

        EU Medical Device Directive (MDD) training and consulting

        Hazard / Risk Analysis, P/DFMEA, and LCA consulting and training

        Essential requirements consulting and training

        Technical file and design dossier consulting and training

        EU Authorized Representative coordination   

        EU Pharmaceutical Directive 65/65/EEU consulting and training

              Clinical and regulatory affairs consulting and training.