Protocol Deviations: Avoidable Problems or an Unavoidable Risk
Track
:
Track 11: Innovative Approaches to Ensuring Compliance with Good Clinical Practice (GCP) and Quality Assurance (QA)
Program Code:
427
Date:
Thursday, June 27, 2013
Time:
10:45 AM to 12:15 PM
EST
Location:
156C
CHAIR
:
Leslie M. Sam, (SCHNON), Director, Global Quality Systems, Eli Lilly and Company, United States
Leslie is a Global Quality System Consultant for clinical development at Eli Lilly & Co. Prior roles included CRA, clinical project management, Six Sigma Black Belt. She is chair of DIA GCP QA SIAC, a member of Clinical Quality round table and considered a thought-leader on Quality Risk Management
SPEAKER
(S):
Maryrose Petrizzo, MS (SPKNON), Manager, Clinical Services- Vendor Management, Allergan Inc., United States
Maryrose has 17 years of GCP experience in Clinical QA and Quality Systems, auditing, inspection readiness, due diligence, acquisition integrations, and clinical vendor management. Always thinking about quality, Maryrose has learned how to balance the business need along with compliance.
Founder, President & CEO of Carolinas Research Associates, an Investigative Site Network in Charlotte, NC. She received a MPH from UNC-Chapel Hill . She has been in research since 1992 as a research coordinator, site manager, business owner & consultant.
Description
There is no consistent terminology or methods to categorize and report protocol deviations. The Good Clinical Practice Quality Assurance (GCP-QA) Community collaborated with industry experts and is working on a paper that will be submitted to a peer reviewed journal for publication. This interactive workshop will share findings and seek your input.
**Due to workshop format, seating will be limited and will be available on a first come, first served basis.
The Boston Convention and Exhibition Center (BCEC) has stringent regulations on maximum room capacities, and they are strictly enforced. Once all seats are occupied, DIA will be required to close the workshop, and no more participants will be admitted. Interested attendees are encouraged to arrive at workshops early in order to ensure seating. Please note, as a workshop with interactivity, this event will not be recorded.