34th SQA Annual Meeting and Quality College

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

Abstract:
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.

Category:
University

Level of Content:
Intermediate

B-2 Tactical Questioning 

Abstract:
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.

Category:
Other

Level of Content:
Intermediate