Master Pharmaceutical products Registration in Qatar

Wishlist Share

About Course

Master Manufacturing Site Registration Course | Regulatory Affairs Training for Pharmaceutical & Medical Device Professionals

The Master Manufacturing Site Registration Course is a comprehensive, practical Regulatory Affairs training program designed to provide in-depth knowledge of manufacturing site registration for pharmaceutical products and medical devices. This industry-focused course equips professionals with the skills required to prepare, review, and submit complete manufacturing site registration dossiers in compliance with health authority requirements.

Manufacturing site registration is a critical prerequisite for successful product registration, making this course essential for regulatory affairs specialists, quality assurance professionals, pharmaceutical manufacturers, medical device companies, consultants, and compliance teams seeking to strengthen their regulatory expertise.

Throughout the course, participants will gain hands-on knowledge of the complete manufacturing site registration process, including:

  • Manufacturing site submission letters
  • Site registration dossiers
  • Regulatory checklists
  • Application forms
  • Site Master File (SMF/SMP) validation
  • Manufacturing site audits
  • Corrective and Preventive Actions (CAPA)
  • Site registration renewal procedures
  • Current regulatory requirements and latest health authority updates

The course also explains one of the latest regulatory changes, including the discontinuation of parallel registration, ensuring participants stay updated with current regulatory expectations and compliance requirements.

Developed from real-world regulatory practices, the Master Manufacturing Site Registration Course combines practical guidance with industry standards, enabling participants to confidently manage manufacturing site registration projects and support successful pharmaceutical and medical device product registrations.

Show More

What Will You Learn?

  • This comprehensive Qatar Pharmaceutical Regulatory Affairs Course provides practical, industry-focused training on the complete drug registration process in Qatar, helping professionals navigate regulatory requirements with confidence.
  • Course Topics
  • Introduction to Qatar's Pharmaceutical Regulatory Framework – Understand the regulations, health authority requirements, and compliance standards governing pharmaceutical and medical product registration in Qatar.
  • Step-by-Step Drug Registration & Submission Process – Learn the complete pharmaceutical product registration workflow, from dossier preparation to regulatory submission and approval.
  • eCTD Preparation & Electronic Submission – Master the Electronic Common Technical Document (eCTD) format, Module 1 requirements, dossier compilation, validation, and electronic submission best practices.
  • Analytical Documentation & Regulatory Requirements – Gain practical knowledge of analytical documentation, quality requirements, regulatory checklists, and documentation best practices to ensure successful submissions.
  • Pharmaceutical Barcoding, Tracking & Tracing – Understand Qatar's pharmaceutical serialization requirements, including GS1 standards, product barcoding, tracking, and traceability for imported medicines.
  • Customs Clearance & 2D DataMatrix Implementation – Learn the regulatory requirements for pharmaceutical imports, customs clearance procedures, and 2D DataMatrix implementation for product identification and supply chain compliance.
  • Pharmacovigilance & Post-Marketing Safety Compliance – Develop expertise in pharmacovigilance (PV), adverse event reporting, risk management, post-marketing surveillance, and after-sales regulatory compliance to meet Qatar's health authority requirements.

Course Content

Module 1: Introduction
In this section we will take off towards mastering pharmaceutical products registration with Qatar, we will start by building up our backbone, our trunk, which is the manufacturing site that we will add our branches later on, which are the pharmaceutical products

  • Introduction
    17:36

Module 2: General guidelines
In this section we will be introduced to the general guidelines for products submission, CTD/eCTD transition, with general tips to be consider that we will master it together

Module 3: Product registration
In this section we will practice the actual pharmaceutical product registration, will practice CTD/eCTD transition, and preparation

Module 4: Core CTD/eCTD
In this section, we will build together the CTD/eCTD structure, module by module, the core for such a pharmaceutical product submission

Module 5: eCTD Guidance
In this section we will sail together into the eCTD guidance issued by Qatar MOH

Module 6: eCTD Guidance 2
In this section we will continue with the eCTD guidance

Module 7: Actual eCTD submission
In this section we will practice the actual eCTD submission, going through the appendices and fill it up together to prepare the full actual dossier for submission 

Module 8: Analysis
In this section we will close our submission with exploring the samples analysis conditions, and documents that need to be sent along

Module 9: eCTD Renewal Guidelines
In this section we will clot the eCTD submission with the renewal and its conditions and documents requirements

Module 10: Actual Forms
In this section we will practice together the actual submission forms

Module 11: Bare coding
In this section we will practice one of the most important aspects for pharmaceutical products, the bare-coding, tender application and delivery conditions of Hamad Medical Institution

Module 12: Closing
In this section, we will end up our journey of pharmaceutical products registered with the state of Qatar, by continuing the bare- coding, shipping,

Module 13: Updated Pricing Guidelines
Be the strategic business development, decide about the pricing, set it as competitive ad be ready to penetrate the market successfully and smoothly

Module 14: Updated Circulars for Updated Requirements
Updated Circulars for Updated Requirements

Earn a certificate

Add this certificate to your resume to demonstrate your skills & increase your chances of getting noticed.

selected template

Student Ratings & Reviews

No Review Yet
No Review Yet

Notify Me When Live

Hiring Notification