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Tuesday, April 10 • 1:30pm - 3:00pm
Session B - Beyond Compliance Track

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B-1  How the adoption of a quality management system can help the reproducibility and reliability of biomedical research: Oswaldo Cruz Foundation´s experience

In recent years, there has been increasing concern about the reproducibility and reliability of biomedical research. The lack of reproducibility in the research has a consequence from the non-confirmation of the results obtained with its attainment until rework and increase of costs. Recent studies indicate categories of errors that contribute to the irreproducibility of the research. These are: biological reagents, reference materials, research design, data analysis and laboratory protocols. The Oswaldo Cruz Foundation is a federal institution linked to the Brazilian Ministry of Health. Created in 1900, Fiocruz seeks to interconnect the fields of science, technology and health, conducting activities that include the development of research, provision of laboratory reference services, as well as, manufacturing of vaccines and drugs.  There are currently 271 research lines underway at the institution where about 1.500 research projects are developed. Since there are no international applicable standards and/or regulations documents that guide the adoption of good practices in research, Fiocruz has adopted two documents: the published by the World Health Organization entitled Handbook: Quality Practices in Basic Biomedical Research and the published by the São Paulo Research Foundation entitled Code of Good Scientific Practice. These documents include questions on quality policy and staff responsibility, physical resources, prescriptive and descriptive documents, a calibration and maintenance program for equipment among others. The adoption of these documents in Fiocruz is at an early stage, but there is already an improvement in the adoption of good practices, including document structuring, recording of activities and systematization of different practices.


Level of Content:

B-2 Tactical Questioning 

While the FDA, FBI, and other law enforcement are provided training in investigative interviewing, our industry QA professionals rarely have such training to assist them in conducting their roles including, but not limited to, performing audits and other quality assessments. This 90-minute session, led by a former FBI Special Agent William Vincent, will detail the most current interview and communication training which until recently was only available to government agents. It will address the reasons for the resurgence of the study of interviewing, as well as why the new research dispels some previously held beliefs regarding effective interviewing techniques. This training will introduce you to key practical takeaways to assist you in becoming a more successful interviewer as well as interviewee.Former FDA Investigator Laurie Taddonio and QA Consultant Robin Guy will join the panel to provide additional perspectives.


Level of Content:

avatar for Robin Guy

Robin Guy

GLP and Toxicology Consultant, Robin Guy Consulting, LLC
ROBIN C. GUY, M.S., D.A.B.T., RQAP-GLPRobin has been a toxicology and GLP consultant for the last 18 years for Robin Guy Consulting, LLC. Robin has extensive QA work experience involving administering GLP training courses (FDA, EPA, OECD), assisting labs with recommendations on how... Read More →
avatar for Renata Souza

Renata Souza

Oswaldo Cruz Foundation
Science and Technology Specialist from Oswaldo Cruz Foundation, acting as Quality Coordinator of the institution. Graduated in Biological Sciences with a doctorate in science and post-doctorate in the implementation of health quality management systems. Renata has training in the... Read More →
avatar for Laurie Taddonio

Laurie Taddonio

President, LMT Consulting LLC
LAURIE TADDONIO, LMT Consulting LLC: Laurie is an independent consultant with 25+ years of experience in the FDA-regulated industry, including 10 years with the FDA as a Bioresearch Monitoring Specialist Investigator, BIMO Program Manager, International Inspection Team member, and... Read More →

William Vincent

Principle, G-Frog Consulting
Bill Vincent is a retired FBI Special Agent, former Police Officer and High Value Detainee Interrogation Group (HIG) interrogator/instructor. Bill spent 15 years working International Terrorism cases and 5 years assigned to the Central Intelligence Agency conducting human source... Read More →

Tuesday April 10, 2018 1:30pm - 3:00pm PDT
Platinum 1&2