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.
You'll learn:
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
Quality Risk Management for FDA/ICH Q9 Compliance
The Course Curriculum:
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”
Regulatory Foundations
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:
People risks
Product risks
Process risks
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 and the risk management process interact
The Initial Risk Evaluation:
Proven tools to assess, evaluate and prioritize risks:
Processing mapping
HAZOP
Ishikawa diagrams
Fault Tree
HACCP
FMEA
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
Benefit from interactive exercises to apply and retain your learning
Quality Risk Management for FDA/ICH Q9 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.
Janis Olson, EduQuest 22 years as global FDA investigator and regional office director; certified ARC/PDA Auditor |
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.
“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.” (Introduction to Risk Management for FDA Compliance course, 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.”
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2013 Course Schedule:
April 11-12, 2013: Hilton Garden Inn, Frederick Maryland (near Baltimore, Maryland and Washington, DC). For sleeping room reservations, visit www.frederick.stayhgi.com or call +1 (866) 909-6090. Use Group Discount code QUEST1 for sleeping rooms at $119/night plus tax. Discount rate available until March 18, 2013.
Fly into Baltimore-Washington International (BWI) Airport or Washington Dulles International (IAD) Airport, each approximately a 1-hour drive from Frederick.
Day 1: 8:30 am. – 5:30 pm; Day 2: 8:30 am – 12:30 pm.
Lunch on Day 1 and refreshments provided throughout the program.
To be notified when additional dates and locations are confirmed, subscribe to EduQuest’s free monthly newsletter delivered by email, EduQuest-ions & Answers. Click here to subscribe.
This course can be delivered directly at your facility, when and where convenient for you and your colleagues. Request a price quote from ClarenceDanielson@EduQuest.net.
Class registration is easy. To enroll or get more details:
(download
Registration Form for April 11-12, 2013, course in Frederick, Maryland)
Or Email Martin at Info@EduQuest.net
Or call +1 (301) 874-6031 between 9 a.m. and 5 p.m. Eastern U.S. Time
Tuition for Quality Risk Management for FDA/ICH Q9 Compliance is $1,495. Register 5 students for the price of 4. Significant discounts also are available for teams of 2 or more from the same company who register together.
Combine this course with the 3-day FDA Auditing of Computerized Systems and Part 11/Annex 11 course (offered on Monday through Wednesday, April 8-10, 2013, in Frederick, MD prior to the Quality Risk Management course) and save $495 on the combined course tuition.
RETURN TO EDUQUEST CURRENT COURSES SUMMARY PAGE HERE
EduQuest: EDUcation: QUality Engineering, Science and Technology www.EduQuest.net +1 (301) 874-6031