Email Info@EduQuest.net to bring this class directly to your site -- when and where convenient for you
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.
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 study tools and methodologies used by regulated companies around the world.
With that foundation, you'll also examine how FDA's approach compares with risk management concepts addressed in the latest ISO standards and in ICH's Q9 Quality Risk Management guidance (which has been adopted by FDA).
You'll also study tools and methodologies used by FDA-regulated companies around the world. You'll get hands-on experience using such tools as Fishbone and Ishikawa Diagrams; Failure Mode and Effects Analysis (FMEA), and Hazard Analysis and Critical Control Points (HACCP). You'll work with process maps, construct Cause-and-Effect Matrices, and develop tables for evaluating Severity-Likelihood of Occurrence-Detection and residual risks.
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, ISO 9001:2015, ICH Q9, and FDA's GxP rules
What's ahead -- and why you must develop a mindset to continuously evaluate risks
√ 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
√ Write a risk management plan
√ 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
Definitions: Getting Proficient in the Language of Risk
Concepts and definitions used by FDA
Differences between FDA and ISO/ICH terms
Relationship between “use” and “risk”
The history of managing risks in drugs and devices
Current FDA rules mandating risk management
Latest FDA/ICH guidance and policies
Overview of Risk Management Approaches
FDA’s “3P” expectations for managing:
Role of risk management in compliant GxP and electronic record-keeping systems
Key Principals of Risk Management
Relationship of Severity, Likelihood and Detectability
Introduction to tools for risk assessment and hazard control
Learning which tools work best in what situations
Risk Management Planning
Methods for integrating risk management with your quality system
Using risk management to better understand and improve processes
Lifecycle risk management – why it’s critical, and when it’s required
The Risk Assessment Process
The ISO 14971 risk management model
How Six Sigma, ISO quality standards and the risk management process interact
The Initial Risk Evaluation:
Proven tools to assess, evaluate and prioritize risks:
Mitigating Risk: Preparing and Implementing a Plan
Understanding and accounting for residual risk
How to factor risk mitigations into residual risk estimates
The biggest mistakes companies make in implementing risk mitigations
Risk Management Reports and Communication
What factors you should document in your overall risk evaluation
Communicating risks: key principles and best practices
Identifying risk communication audiences
Post-Launch Reviews: Process Risk Performance and Feedback
Monitoring ongoing risks throughout the product’s life
Using quality system data to manage process risks during commercial production
Gathering and integrating feedback from the field
Quality Risk Management for FDA/ISO/ICH Compliance will offer engaging and informative exercises designed to help you apply the course concepts, terms and tools to real-world problems you’re likely to face back at your job. Exercises will focus on both product and process (manufacturing) risks. Initially, you and your classmates will analyze and establish the risks associated with a hypothetical product. Then, you’ll move on to determine the product’s manufacturing process – and more importantly, the risks in the process that could cause risks to the product’s safety and effectiveness.
EduQuest is a global team of FDA compliance experts headquartered near Washington, DC. Celebrating more than 20 years of service to FDA regulated industry, EduQuest was founded in 1995 by three former FDA rule-makers and expert field investigators.
Since that time -- through hundreds of training classes and consulting assignments worldwide -- EduQuest has helped thousands in the medical device, pharmaceutical, biologics, food and tobacco industries better understand FDA expectations, prepare for FDA inspections, resolve FDA enforcement disputes, and upgrade their Quality Systems to world-class standards.
"Unsolicited plug: EduQuest seminars are excellent! If you can attend, you should. I've been to several of your seminars over the years, enjoy them, and always leave with a pile of new information." (Doug Finner, Elbit Systems, May 2011)
Janis Olson, EduQuest
22 years as global FDA investigator and regional office director; certified ARC/PDA Auditor; internationally recognized expert on quality risk management, computerized system and process validation, and supplier auditing
Janis Olson is a Vice President of Quality and Regulatory Services with EduQuest. Previously, she worked at FDA for more than 22 years, where she conducted domestic and international inspections and capped her Agency career as the Director of the Information Resources Management Office in FDA’s Southeast Region. Currently, Jan helps EduQuest clients comply with GxP regulations and apply risk management concepts and tools to meet FDA’s expectations and international standards. She also helps clients prepare for FDA inspections through training, writing and updating SOPs, and reviewing computer validation documentation. She has chaired PDA’s Industry Review Board for the Audit Resource Center (ARC) and was on the PDA task force that wrote Technical Report 32 on Computer System Supplier Auditing. Jan is certified as an ARC/PDA auditor and was a member of the PDA task force that wrote the Good Electronic Records Management (GERM) document.
"Knowledge of the instructor was clear, the examples were real to life -- very meaningful." (April 2013, Frederick, MD)
"[Strength of this course was] knowledge of instructor and explanations of terms/tools, plus many examples from industry were presented. CD-Rom is an excellent resource also." (April 2013, Frederick, MD)
“Great course! My organization has experienced being under the microscope lately due to FDA warning letters and 483s being issued to our clients who transferred their obligations. This will give us a starting point for a robust risk management process.” (September 2010, Wilmington, DE)
“[I enjoyed] the ability to receive information directly from a former FDA investigator. It was also good to hear the Q/A from various individuals from various locations and companies.” (April 2009)
“Very knowledgeable, experienced instructors. Excellent teaching techniques, had answers to all our questions.”
“All the instructors are knowledgeable, articulate and dynamic. The instructors are the most valuable part of the course.”
“Historical knowledge of the instructors and stories they were able to share in order to drive points home was invaluable.”
Quality Risk Management for FDA/ISO/ICH Compliance
This course can be delivered directly at your facility, when and where convenient for you and your colleagues. For details, email EduQuest.
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