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STERILE OPERATION CONSULTANT

? I CAN PROVIDE FOLLOWING SERVICES:- For Establishment of robust process and System, Streamline ,Qualification and Validation, Regulatory Compliance Development of Manpower, Development of work culture, cGMP. Compliance Training with Respect to cGMP, GDP, Data Integrity, Regulatory Guidelines, Qualification Protocol, Aseptic Practices and Behavior, Clean Room Maintenance, SOP, URS ? Equipment, Process, HVAC, ULAF, Clean room training to understand basic principle Behind it. ? Importance of Disinfectant, Sanitization and Clean room cleaning and maintenance ? Basic Principle of Steams like Saturated Steam, Superheat steam and Flash steam ? Complete training and Qualification with Related to Water system, design, Qualification, and Its maintenance ? Operation Excellence- Basic and practicable approach of Streamlining the Filling, Inspection and Packing lines. Basic and Practicable approach of Development of work force which will be highly motivated, high on integrity and highly compliance adherence without compromising Quality and Productivity ? Sterile Operation: Aseptic Operation, Terminally Sterilized Operation ? Visual Inspection: Manual Inspection, Automatic Inspection, Automatic Inspection Qualification, Manual Inspection Qualification, Visual Inspection Qualification, Visual Inspector Qualification, Visual Inspection Kit Preparation, Visual Inspection Kit Qualification, Automatic Inspection Process Development. ? Leak Detection, Labelling and Packing process and Equipment ? CIP, COP and Cleaning Validation ? Sterilization and Depyrogenation: Steam Sterilization, Dry heat Sterilization & Depyrogenation, Terminal Sterilization, SIP ? Medial Fill, Filter integrity & Filtration, Container Closure Integrity. ? Equipment Qualification: Washer Qualification, Tunnel Qualification, Filling & Sealing machine Qualification. ? Basic understanding of QMS element, Change control, Deviation, Investigation and CAPA and its management

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$25/hr Ongoing

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? I CAN PROVIDE FOLLOWING SERVICES:- For Establishment of robust process and System, Streamline ,Qualification and Validation, Regulatory Compliance Development of Manpower, Development of work culture, cGMP. Compliance Training with Respect to cGMP, GDP, Data Integrity, Regulatory Guidelines, Qualification Protocol, Aseptic Practices and Behavior, Clean Room Maintenance, SOP, URS ? Equipment, Process, HVAC, ULAF, Clean room training to understand basic principle Behind it. ? Importance of Disinfectant, Sanitization and Clean room cleaning and maintenance ? Basic Principle of Steams like Saturated Steam, Superheat steam and Flash steam ? Complete training and Qualification with Related to Water system, design, Qualification, and Its maintenance ? Operation Excellence- Basic and practicable approach of Streamlining the Filling, Inspection and Packing lines. Basic and Practicable approach of Development of work force which will be highly motivated, high on integrity and highly compliance adherence without compromising Quality and Productivity ? Sterile Operation: Aseptic Operation, Terminally Sterilized Operation ? Visual Inspection: Manual Inspection, Automatic Inspection, Automatic Inspection Qualification, Manual Inspection Qualification, Visual Inspection Qualification, Visual Inspector Qualification, Visual Inspection Kit Preparation, Visual Inspection Kit Qualification, Automatic Inspection Process Development. ? Leak Detection, Labelling and Packing process and Equipment ? CIP, COP and Cleaning Validation ? Sterilization and Depyrogenation: Steam Sterilization, Dry heat Sterilization & Depyrogenation, Terminal Sterilization, SIP ? Medial Fill, Filter integrity & Filtration, Container Closure Integrity. ? Equipment Qualification: Washer Qualification, Tunnel Qualification, Filling & Sealing machine Qualification. ? Basic understanding of QMS element, Change control, Deviation, Investigation and CAPA and its management

Skills & Expertise

HvacQmsRegulatory ComplianceSOP

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