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