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