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:
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Baseline assessment (gap analysis)
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Building and facilities audits
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Quality steering team (committee)
set-up, implementation, and coordination
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Quality system implementation
planning, with detailed timelines
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Registrar selection training
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Management and employee quality
systems overview training
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Documentation training
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Internal auditor training (quality
system, product, process and performance)
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Detailed training for the quality
steering team (12 sessions)
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Detailed quality systems training
for employees (six sessions)
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Management review meeting planning
and coordination
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Statistical analysis
identification, planning, training, and coordination
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Monitoring and measurement of
processes training
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Monitoring and measurement of
product training
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Customer satisfaction system
definition, implementation, and coordination
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Process validation training
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Flowcharting training and
consulting (micro and macro) to interconnect processes (organizational and
functional levels)
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Product verification and validation
training (hardware, software, firmware, and drivers)
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Root cause analysis training
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Preventive action definition,
implementation, and coordination
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Pre-assessment audit, with full
reporting
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On-site assistance during the
registration final audit
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Assistance in responding to audit
nonconformities (if any)
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Sterilization, bio-burden, and
environmental monitoring training and consulting
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Labels and labeling training and
consulting
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EU Medical Device Directive (MDD)
training and consulting
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Hazard / Risk Analysis, FMEA, and
LCA consulting and training
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Essential requirements consulting
and training
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Technical file and design dossier
consulting and training
·
EU Authorized Representative
coordination
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EU Pharmaceutical Directive 65/65/EEU
consulting and training