Quality Risk Management

 

for FDA/ICH Q9 Compliance

 

Agency Expectations - Global Standards - Tools for Success

 

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.

 

You'll learn:

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:

 

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.

 

About Your Course Leader:
30+ years of experience; 22 years as an FDA investigator and official

 

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.”

 

 

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.

 


 

Date and location don't fit your schedule?

On-site, on-demand training is available when and where you need it

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