Naratech Training Center

Naratech believes that training & building capacity programs are most crucial to enhance the staff capabilities & get the best results any firm orregulatory body aims to achieve.

Naratech building capacity programs is designed &customized by the most experienced professionals 

who have spent years in the pharmaceutical industry in order to enhance & fill the gaps related to the

individuality of every firm or regulatory body after meeting the staff & studying their capabilities.

Hence, Naratech alone or in corporation with international specialized companies provides the following building capacity.

Good Manufacturing Practices - GMP Compliance

• Introduction to GMP
• Good Documentation Practices
• GMPs for the Warehouse
• Microbiology in the Workplace
• Cleaning & Sanitation
• Documentation & Records
• Contamination Control
• Production Control
• Packaging Control
• Quality Assurance & Quality Control
• Pharmaceutical CAPA
• Pharmaceutical Risk Management
• Product development
• Self- inspection & Quality audits(Six systems inspection Model)
• FDA pre approval inspection preparation

Good (Control) Laboratory Practices

• Introduction to Good (Control) Laboratories
• Microbiology Laboratory Practices
• OOS Handling System
• Analytical Method Validation
• IQ/OQ for Laboratory Equipment
• Basic Statistics for QC Labs
• Pharmaceutical Sampling Plans
• Stability Programs
• Microbiology & GLP

Validation & Qualification

• Validation Principles & International Regulations
• Validation Master Plans & Documentation
• Commissioning & Installation Qualification
• Operational & Performance Qualification
• Equipment Cleaning Validation
• Water systems Qualification
• HVAC Qualification System

Good Regulatory Practices 

• Preparing Submission in the Common Technical Document ( CTD ) Format 
• Define Good Regulatory Practice (GRP)
• International principals of Good Regulatory Practice
• Current Good Regulatory Practice in Arab region
• Quality Management within Good Regulatory Practice
• Good guidance Practice
• Good review practice 

Current Regulations on Drug Supply Chain Management

• Good Storage & Distribution Practices (GSDP)&Good Cold Chain Management Practices (GCCMP) General Rules & Principals
• WHO, EU, HC, FDA, USP Regulations, Standards & Guidelines for cGSDP
• Quality Management System for Pharmaceuticals Storage & Distribution:
  
  • Quality Manual / Site Master File
  • Responsibility of the Management Board
  • SOPs & Quality Protocols
  • GDP in Pharmaceutical Storage & Distribution
• Qualification, Validation & Mapping of Equipment, Facilities, & Cold Chain Tools
• Current Cold Chain Tools Technologies & Techniques
• Stores Design & Product Flow

Current Good Manufacturing Practices ( cGMP ) For Cosmetics - ISO 22716

• Introduction to ISO 22716
• Scope of GMP Compliance:
  • Facility
  • Utilities
  • Personnel
  • Equipment
  • Quality System
  • Packaging & Labeling
  • Packaging & Labeling
  • Good Documentation Practices
  • Quality Manual
  • Standard Operating Procedure ( SOP )
  • Good Laboratory Practices
  • Reporting testing data
  • Handling OOS
  • Instrument calibration & qualification 

Good Vaccine Management Practices

• Choosing Vaccine Storage Site
• Vaccine Personnel
• Storage & Handling Plans
• Storage Equipment & Practices
• Temperature Monitoring
• Storage Troubleshooting
• Requirements for Handling Selected Biological
• Inventory Management
• Vaccine Transportation & Shipments
• Preparation & Disposal
• Vaccine-Management assessment elements

GDP Compliance Certificate - According to EU GDP 2013

• Current GDP guidelines related to drug storge & distribution ( Overview & focus on the updates )
• Risk assessment in pharma supply chain management
• GDP inspection check list - insight on inspection report content & action plan for corrective measures
• Getting certified for EC 2013 GDP compliance certifciate

Scale - Up and post Approval Changes ( SUPAC ) 

• Define the concept of SUPAC and line extension requirements as applied to post marketing regulatory activity according to latest updated EU, FDA, SFDA & JFDA perspectives
• Identify which type of variation is appropriate for the change being proposed & to specify the additional tests & data required
• Support the variation being made according to EU, FDA, and SFDA & JFDA guidelines/requirements

• Bioequivalence: The Concept, Requirements, Monitoring & Inspection 

• Reference and test product, Subjects, Study conduct and Strength to be investigated
• Characteristics to be investigated
• Evaluation and Statistical analysis
• In vitro dissolution tests required for bioequivalence
• Important issues to consider during monitoring of bioequivalence study
• Introduction to biowaivers & BCS-based biowaiver
• Dissolution requirements for biowaivers
• Biowaivers in case of registration of multiple dose strengths
• Biowaivers of other dosage forms