Get practical, interactive classroom training
from former FDA investigators and expert advisors
who train and consult for global industry leaders.
Risk management is the bedrock of FDA regulation in the 21st century, especially for quality systems and GxP compliance.
In today’s global economy, you also must keep up with the increasing number of international standards for assessing and controlling risks. If you ignore the growing demand for product risk management – throughout your product’s entire lifecycle, from cradle to grave – you’re endangering your company’s bottom-line and public reputation.
In just a 12 hours, you’ll have risk management "de-mystified"
by understanding every-day terms, real-world situations,
and concepts you can use right away
Ask 10 companies how they define risk, and you’re likely get 10 different answers. How can you and your team master something as elusive but vital as risk management? Begin by attending EduQuest’s 12-hour training class and learn FDA’s approach to assessing and managing risk.
You’ll also study tools and methodologies used by regulated companies around the world.
FDA’s expectations for managing people, product and process risks
The language of risk – key concepts and definitions of risk management used by FDA and international bodies
The regulatory requirements for risk management
Proven tools for risk assessment, management and hazard control (with hands-on practice)
How to better integrate risk management with your quality system
The inter-relationship of ISO 14971, ICH Q9, and FDA's GxP rules
What's ahead -- and why you must develop a mindset to continuously evaluate risks
After attending this course, you’ll be able to:
√ Speak the same language of “risk” with inspectors, regulators, and ISO auditors
√ Articulate the pay-back of risk management to senior management
√ Know how to meet U.S. and international standards for risk management
√ Identify and assess risks by applying the right tools to real-world situations
√ Mitigate identified risks – and communicate those risks to the appropriate audiences
√ Use risk management to upgrade your GxP programs and electronic records
√ Incorporate lifecycle risk management in your products and processes
√ Apply a consistent, documentable approach to risk management for your company