Biomedical subjects

P O Pomerleau

Publications and source records attributed to P O Pomerleau.

3 recordsLinked to original sources

PubMed1994

Looking back--a history of progress: Society of Quality Assurance.

The Society of Quality Assurance (SQA) Historical Committee has tracked the impressive evolution of our society from the initial sharing of ideas at the 1980 Quality Assurance Roundtable meeting to the formation of the national SQA in 1984, to a 12-fold increase in membership numbers through 1993. This article describes annual meeting locations and attendance, membership numbers, and organizational information, as well as significant milestones for both the Quality Assurance Roundtable group and the SQA.

History, 20th Century↗

PubMed1994

Performing GLP studies in a traditionally non-GLP facility.

Situations can arise in which traditionally non-GLP facilities may have to be used for performing nonclinical GLP studies or parts of a GLP study. The situations may include a need for particular expertise of scientists, the analytical laboratory, or the development of an unusual product. This article describes the use of a core group model as a proactive strategic plan to bring the traditionally non-GLP facility into compliance before the GLP study is conducted. The core group team is composed of representatives of both the Sponsor and the facility where the GLP study will be conducted. The core group model uses a nine-step plan that fosters good communication, co-operative planning, and adequate preparation before initiation of a proposed GLP nonclinical study, conducted under GLP compliance, at a traditionally non-GLP facility.

Facility Regulation and Control↗

PubMedDate not supplied

Compliance education through participational QA programs.

Attaining and sustaining an acceptable level of compliance to regulations, guidelines, or directives presents a challenge to every company. Compliance education programs usually combine in-house tailored programs with extramural courses, both of which are very valuable. It is recommended that two motivational participational Quality Assurance programs be added to your compliance education: (1) Deputy Quality Assurance monitoring program and (2) Quality Assurance group auditing. Both programs provide the researcher active involvement, on an ad hoc basis, in the compliance assessment process, and an increased awareness of the practical application of compliance principles. Through self-discovery and team building, both the researcher and Quality Assurance gain a mutual trust and respect for their respective expertise. Motivation is enhanced through this environment and provides a self-perpetuating impetus for proactive improvements in the compliance process. From a Quality Assurance perspective, effective compliance education combines in-house tailored compliance programs and extramural courses or meetings with these two participational Quality Assurance programs. The combination has the potential for going beyond our basic understanding of compliance and creating a compliance consciousness that can successfully translate into continually improving our compliance programs.

Humans↗