Product Details
Are you caught up on the latest version of the ICH Q9 (R1) Quality Risk Management guideline? Revisions clarify the expectation that quality risk management should be consistently used within all elements of the system — the FDA expects to see proof that a risk-based approach was applied throughout the product lifecycle.
Attend this presentation, led by Beth Slater, an expert in the development, implementation and remediation of quality systems, who provides a clear understanding of the tools used for risk management in the QMS and how to properly apply them throughout the product lifecycle.
During this presentation, Slater will present actual case studies of real-life situations where risk management tools could have prevented quality system issues, and more.
Key Presentation Takeaways:
- Expert insight into the ICH Q9 (R1) Risk Management Guidance changes
- Knowledge of how to integrate Risk Management into QA processes
- Understanding of the tools and methods for implementing and measuring risk management within a QA system
Don’t miss this opportunity to ensure compliance with the revised FDA guidance.
Meet Your Presenter
Beth Slater started Quality Confidential in 2017 after 30 years in the pharma, biopharma, and medical device industries. She is an expert in the development, implementation, and remediation of quality systems. Her areas of expertise include the interpretation of global regulations and standards, risk management, root cause analysis, and training.
Slater maintains certifications in auditing (CQA) and Six Sigma (Green Belt). Her last position prior to starting Quality Confidential was as the corporate auditor for a global medical device company.
Who Will Benefit
- Quality Assurance
- Project/Program Managers
- Clinical QA Leaders