Assessing and controlling risk is essential throughout the product life cycle of a drug, from research and clinical testing to manufacturing and distribution. Organisations must demonstrate to the competent authority that a documented plan is in place to identify, measure, control, and monitor the various risks that exist.
Through case studies and examples you will gain a detailed view of risk from a regulatory perspective by examining simple risk assessment techniques and mitigation methods for specific risks including product recalls. Once completed you will better understand risk from the authority's point of view, enabling you to be better prepared for questions from global regulators. It will allow you to create robust risk management reports with advanced strategies for a variety of products.
What will you learn?
Quality Risk Assessment reports
Learn how to build a robust Quality Risk Assessment report
Identify and understand the areas of Pharmaceutical Risk Management to manage risks more effectively
Communication with authorities
Learn how to effectively deal with authorities
Learn how to mitigate risks
Post market product risk management
Understand the post-market procedures you will need to undertake
Who is this course for?
This course has been specifically designed to address the needs of:
- Regulatory Affairs Managers/ Officers/ Assistants
- Compliance Managers
- Documentation Managers
- Product Registration Personnel
- Project Managers in Regulatory Affairs
- Qualified Persons
- Senior-level managers who need an overview
Engaging in Continuing Professional Development ensures that both academic and practical qualifications do not become out-dated or obsolete; allowing individuals to continually ‘up skill’ or ‘re-skill’ themselves, regardless of occupation, age or educational level. This course has been assessed and is CPD certified.