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Buscar por https://www.qualipharmagroup.com/en/
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Consulting
Risk Assessment Experts
Crisis Avoidance – Rescue Plan
Experts in Cross-Contamination
GMP Audits
ICH Q3D Implementation – Elemental Impurities
Analytical Development
Project Management
Medical Cannabis
GxP Global Solutions
Medical Devices
CE Marking: technical and regulatory aspects for its application.
Quality System EN ISO 13485: 2016
VALIDATION OF SOFTWARE AND APPS
POSTCOMERCIALIZATION FOLLOW-UP
COMMERCIALIZATION IN USA – FDA REQUIREMENTS
CSV
Data Integrity
Computerized Systems Validation
Systems Evaluation and Action Plans
Development of IT Quality System, Policies and Procedures
Support to Systems Developers
Serialization
GDP
Risk Assessment on Transportation Routes
Cold Chain Assessment: Temperature Mappings
Logistics Operators Audits
Clients Qualification: Pharmacies, Wholesalers and Hospitals
GDP Training Courses
Implementation of GDP Quality System
Implementation of Measures to avoid Drugs Counterfeiting
Implementation of Cost-Saving Measures
Validation of Transportation Routes
Qualifications
Clean room qualification (HVAC)
Environmental Control in Clean Rooms (HVAC System) and Laminar Flows
Microbial Test in Compressed Air / Gas Equipment
Maintenance and Qualification of Safety Cabinets, fume hoods and Isolators
Cross-Contamination: Environmental Verification
Qualification of Particle Counters Monitoring Installations
Thermal equipment qualification
Temperature Mappings in Autoclaves
Temperature Mappings in Freeze drying, Autoclaves, Tunnels and Sterilization Ovens
Mappings in Temperature Controlled Equipment: Drying Oven, Incubators, Freezers, Ultra Low Temperature Freezers
Temperature Mappings of Warehouses, Storage Areas and Vehicles
GMP Fluids Qualification
CIP/SIP Cleaning System Qualification
Production equipment qualification
Analytical Instruments Qualification
Validations
Cleaning validation
Validation of Reception, Storage and Dispatch Process
Production Process Validation
Analytical Methods Validation
Computerized systems validation
Pharmaceutical Process Validation
Calibrations
Particle Counters Calibration
Measuring Instruments Calibration
Training
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