Overview
Regulatory Affairs & Drug Registration is part of the Pharmaceutical & Laboratory track at Garnet Global Training Center. GMP, quality and laboratory programs for pharmaceutical, medical device and testing organisations. The course is taught in English or Arabic as a 5-day or 10-day program, in classrooms in cities such as Dubai, Riyadh, Cairo, London and Istanbul, or live online, and it can be delivered in-house with examples and exercises built around your own operations.
What you will be able to do
- Explain the principles, terminology and standards that govern Regulatory Affairs & Drug Registration.
- Apply proven methods and tools to real situations from your own workplace.
- Analyse performance gaps, risks and root causes, and choose the right response.
- Measure results with practical indicators and report them clearly to management.
- Leave with a personal action plan you can start using the following week.
Who should attend
QA/QC staff, production and laboratory personnel, regulatory affairs specialists.
Key topics
- GMP and GLP principles
- Validation and qualification
- Documentation and data integrity
- Deviations and CAPA
- Regulatory submissions
- Laboratory instruments
5-day outline
Day 1 Foundations of Regulatory Affairs & Drug Registration
- Scope, terminology and governing standards
- GMP and GLP principles
Day 2 Methods and tools
- Validation and qualification
- Documentation and data integrity
Day 3 Application and case studies
- Deviations and CAPA
- Laboratory instruments
Day 4 Performance, risk and compliance
- Regulatory submissions
- Measurement and reporting
Day 5 Workshop, assessment and action plan
- Hands-on workshop on a workplace challenge
- Final assessment and personal action plan
10-day outline
Day 1 Foundations of Regulatory Affairs & Drug Registration
- Scope, terminology and governing standards
- GMP and GLP principles
Day 2 Methods and tools
- Validation and qualification
- Documentation and data integrity
Day 3 Application and case studies
- Deviations and CAPA
- Laboratory instruments
Day 4 Performance, risk and compliance
- Regulatory submissions
- Measurement and reporting
Day 5 Workshop, assessment and action plan
- Hands-on workshop on a workplace challenge
- Final assessment and personal action plan
Day 6 Advanced techniques and specialist practice
- Complex cases in depth
- Common mistakes and how to avoid them
Day 7 Digital tools, data and automation
- Analysis tools and software
- Using AI in this field
Day 8 Benchmarking against international practice
- Global performance benchmarks
- International case studies
Day 9 Capstone project
- Analyse a real challenge from your organisation
- Build the solution and implementation plan
Day 10 Presentations, final assessment and certificates
- Project presentations and review
- Final exam and certificate award
Certificate
Participants who attend at least 90% of sessions and complete the final assessment receive a certificate of completion stating 35 contact hours (5-day) or 70 contact hours (10-day).