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)
·
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
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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
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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, 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