How to Survive a QRM Audit
As QRM tools and techniques become more formalized, regulatory agencies are increasingly requiring companies to establish Quality Risk Management Plans for their operations.Such plans are being used as starting points for regulatory audits. Additionally, to keep in step with the evolution of science and technology, agencies are frequently updating their approach to auditing quality and risk management. This dynamic nature has significantly contributed to an increase in citations. Consequently, companies should become familiar with performing QRM activities that meet compliance requirements.
Attend this webinar to find out what regulatory agencies always look for when auditing a company QRM system. Addressed will be QRM compliance requirements such as critical steps for establishing a QRM infrastructure, factors to consider when developing risk ranking criteria and heat maps, what and how to fill in the templates to document QRM results and what regulatory agencies expect when you communicate your QRM results to them and other stakeholders.
Areas Covered in the Session:
Using real world examples, the webinar addresses the following:
Who Will Benefit:
- Why is it important to adhere to the ICH Q9 process
- What are the principles and elements of QRM
- Who are the key members of a QRM team and their roles and responsibilities
- What are the various risk assessment tools and how to select one that is appropriate
- QRM documentation strategy and how to document QRM results using templates
- What are the key elements for developing a communication plan for QRM results
- How is QRM audited
- How to prepare for the audit and how to defend the audit
- Process and Manufacturing Sciences
- Compliance, Regulatory