Employing a Quality Systems Management Approach to Improve Clinical Trial Monitoring

Date: Saturday, Oct. 11 Time: 8:00 am – 5:00 pm Location: The Alexis Park Resort Hotel, 375 East Harmon Avenue, Las Vegas, NV Advanced Registration Deadline: Sept. 30 Online Registration Deadline (with $150 late fee): Oct. 7 Contact Hours: 6 Member Price: $499 Non-Member Price: $649 Hotel Information: Call (800) 582-2228 for hotel reservations, mention attending ACRP 2008 Workshop Weekend, and get a discounted hotel rate of $129/night. These rooms are available on a first-come first-served basis. Discounted rates are not available after September 15. If you don't want to register online, please use this printable registration form.

Improve your clinical trial monitoring.

Analyze recent FDA Warning Letters which cite problems that could have been prevented and learn to preclude these errors by employing a Quality Systems Management Approach in your clinical trials.

Learn how to perform root cause failure analysis and how to develop comprehensive corrective and preventive action plans (CAPA) to ensure compliance.

Learning Objectives

Upon completion of this program, attendees should be able to:

• Describe the major categories of deficiencies cited in FDA Warning Letters to clinical investigators over the last five years.
  
  
• Discuss the Quality Systems Management approach to correcting and preventing clinical trial deficiencies.
  
  
• Review predetermined strategies that sponsors can employ to ensure clinical investigator compliance.
  
  
  

Trainers

(Invited) Deidra M. Poucher, RN, MSHS, CCRC, obtained her Master’s Degree (MSHS) in Clinical Research Administration from the George Washington University where she also serves as an adjunct professor.  Her research experience began as a Research Nurse and then transitioned into regulatory affairs and Quality Assurance.  She consults with biotech companies, IRBs and sites for GCP issues including QA Audits, Project Management, Monitoring, Regulatory Affairs, Data Management and regulatory audit preparation.  She served as a lead accreditation surveyor for the National Committee for Quality Assurance and conducts compliance audits for a Central IRB. She is a current IRB Member. 

Deidra M. Poucher, RN, MSHS, CCRC reports that she has no commercial interests to disclose relative to the content of this activity.

Paul R. Below, MA, CCRA, is an independent clinical research consultant currently working with various pharmaceutical and medical device clients on field monitoring and project management contracts.  Previously, he was employed with 3M Pharmaceuticals, Boehringer Ingelheim Pharmaceuticals, and Quintiles as a CRA.  He earned his CCRA in 2001.  He is the Past President of the Minnesota Chapter of ACRP (2004) and is a frequent speaker at national and local chapter ACRP events.

Paul R. Below, MA, CCRA reports that he has no commercial interests to disclose relative to the content of this activity.

Accreditation Council on Continuing Medical Education The Association of Clinical Research Professionals (ACRP) is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. The ACRP designates this educational activity for a maximum of 6.0 AMA PRA Category 1 credits.™ Each physician should only claim credit commensurate with the extent of their participation in the activity.  (Program Number 0007229-08-CME-403) Association of Clinical Research Professionals The Association of Clinical Research Professionals (ACRP) provides 6.0 continuing education credits for the completion of this educational activity with the completion of the evaluation form.  Only claim those credits that are actually earned. These credits can be used to meet the certification maintenance requirement. (Program Number ACRP-2008-ACD-516) Continuing Pharmacy Education TThe Association of Clinical Research Professionals is accredited by the Accreditation Council on Pharmacy Education as a provider of continuing pharmacy education. ACPE Universal Program Number 234-000-08-026-L04-P has been assigned to this program. This program provides 6.0 contact hours of continuing education credit. A statement of credit will be available upon completion of the workshop. Each participant must submit a completed evaluation form at the end of the program to receive a Continuing Education Statement of credit. Partial credit will not be awarded. Release date: 10/11/2008. Continuing Nursing Education The California Board of Registered Nursing approves the Association of Clinical Research Professionals (ACRP) as a provider of continuing nursing education. This workshop provides 6.0 contact hours of continuing nursing education credit (Program Number 11147-2008-ACD-517).