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Naratech Training Center - Naratech.net

Naratech Training Center

Naratech Building Capacity Program & Training Services


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 TRAINING INSIDE

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

 

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