Webinar Date: May 23rd at 3:30 pm IST
Pharmaceutical companies that have implemented Quality Risk Management (QRM) have recognized both compliance and business benefits. And while many companies have implemented some elements of risk management into their processes, regulatory authorities are demanding a risk-based approach to the entire product lifecycle.
In this complimentary webinar, Ann Early, GMP Consultant for UL Compliance to Performance, will share QRM principles and more importantly, provide practical steps you can take to embed risk management controls into your operations and quality assurance processes. During this webinar, Ann will:
- Review ICH Q9, the Quality Risk Management process guidance from ICH
- Discuss recent regulatory observations
- Discuss the elements of a risk assessment, and provide examples of devising “risk numbers” and applying them to deviation investigations
- Discuss the importance of risk evaluation, risk control and risk review
- Outline the steps for establishing a Risk Management Organizational Structure or “Risk Office”
Attendees will also receive an eight-page transcript from Ann's presentation during UL’s Quality Risk Management workshop, held in Hyderabad and Mumbai in March 2017.
About the Presenter:
Ann Early, Senior GMP Consultant, UL EduNeering. Ann has over 20 years of experience as an Aseptic Filling Supervisor, Sterile Operations Manager and Director of Sterile Products for Pfizer. Ann has extensive training for cGMPs, sterile operations, quality systems and FDA audit readiness. She has developed and implemented best practices for developing risk management controls within the production and quality systems areas.