During this workshop you will be introduced to an exceptional, 7-step method that is being successfully used by companies world-wide. Each of the 7-steps is supported by tools to make the investigation process both logical and practical. By attending, you will develop the skills to conduct an investigation to determine the root cause of a serious product problem, so you can institute corrective and preventive action (CAPA).

This is not your typical event where you simply sit back, listen and take a few notes.  From the beginning you will be absolutely engaged. You will be assigned to a team and immediately begin applying the concepts on an intriguing and very real case study as each step is taught. Once you have learned the complete investigational method, your team will be assigned a second more technically complex case study to give you experience applying the concepts so that you will be immediately successful once you return to work.

What others have said about this program:

"This course provides a powerful and efficient approach to problem solving concentrating on initially identifying root cause through a process of elimination based on hard data and facts. I have successfully used this approach to close dozens of investigations in less time than previously and with clearer documentation."
 - Wayne Taylor – Taylor Enterprises

“From my experience using only the Six Sigma approach we would have brainstormed, affinitized, and then screened out unlikely causes. With Tom’s methodology we quickly defined the problem, gathered the pertinent facts, used much more powerful tools to identify possible causes, and tested those possible causes in a significantly shorter period of time.”
 - Debbie Hinton – Black Belt and Principle Process Scientist, Johnson & Johnson

Alonza Cruse is the Director, FDA’s Los Angeles District Office, where his responsibilities include providing executive leadership to one of the largest District Offices within FDA’s Office of Regulatory Affairs. Mr. Cruse implements, manages and evaluates FDA's regulatory operations within the District, which is comprised of the State of Arizona and Southern California including the ports of Los Angeles, Long Beach, and an International Mail Facility. It provides the Executive leadership and technical direction to a multidisciplinary staff in the execution of investigations, enforcement and compliance programs and in the District's day-to-day management.

• Frances J. R. Richmond, Ph.D., Director Regulatory Sciences Program, USC School of Pharmacy
• Deborah Kacera, Senior Product Manager for CAPA and Complaints, Pilgrim
• Cliff Kodama, Director, Quality Systems, Medtronic Diabetes
• Linda Lovett, Director of Quality, Kyphon
• Nancy Singer, Compliance-Alliance
• Rick Waters, Vice President, RA/QA, Newport Medical Instruments

12:00 - 1:00    Lunch

All meeting cancellations must be received in writing. You will then receive a credit to be used for another seminar within one year. No refunds will be given, and there are no exceptions.

Substitutions are accepted at any time. Please provide the substitute's name, title, email and contact information to Nancy_Singer@juno.com or call 703-525-4159.

Registration is Closed

Registration fee                   $ 1195.00