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Naratech Training Center

Naratech Building Capacity Program & Training Services

Naratech believes that training and capacity-building programs are critical to improving employee skills and achieving the best results a company or regulatory agency seeks.

Naratech's capacity-building programs are developed and adapted by the most experienced professionals, who have spent many years in the pharmaceutical industry, in order to improve and fill the gaps related to the individuality of each company or regulatory agency, after getting to know the staff and studying their capabilities.

Therefore, Naratech, alone or in collaboration with international specialized companies, offers the following training opportunities:

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 Laboratories
  • Pharmaceutical Sampling Plans
  • Stability Programs
  • Microbiology & GLP

Validation & Qualification

  • Validation Principles and International Regulations
  • Validation Master Plans and Documentation
  • Commissioning and Installation Qualification
  • Operational and 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 Pharmaceutical 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 storage & 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 certificate

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 and to specify the additional tests and 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