Overview of a quality assurance/quality control compliance program consistent with FDA regulations and policies for somatic cell and gene therapies: a four year experience

<p>High level of quality during design, design-build and construction stages is a fundamental requirement to ensure that structure serves its intended purpose. Establishment of a quality assurance manual is prime necessity. Lack of quality control during design, review and approving design drawings are major reasons for structural failures. Designers and design checkers need to work in tandem to ensure more adequate Quality Assurance & Control (QA/QC).</p><p>In structural design Durability is a key parameter and becomes critical for service life of 100/120 years. In design build and construction stages controlling work quality is important to maintain performance standards. Tailor made quality plan for Design-build Contract is essential. Quality procedures, inspection and testing needs implementation in practice to verify full compliance and prevent occurrence of faults and defects towards durability and service life. This paper deals with Quality with special emphasis on durability in design and construction through case studies of design build contracts.</p>

Download Full-text

Quality assurance and quality control (QA/QC) procedures for mineralogy, porosity, and texture analyses of fine-grained carbonate rocks using automated quantitative mineralogy combined with scanning electron microscopy (AQM-SEM)

10.22443/rms.emc2020.861 ◽

2021 ◽

Author(s):

Stefanie Lode ◽

Keyword(s):

Electron Microscopy ◽

Scanning Electron Microscopy ◽

Quality Control ◽

Quality Assurance ◽

Carbonate Rocks ◽

Fine Grained ◽

Quantitative Mineralogy ◽

Scanning Electron

Download Full-text

A nationwide evaluation of the prevalence of human papillomavirus in Brazil (POP-Brazil study): protocol of data quality assurance and control (Preprint)

10.2196/preprints.31365 ◽

2021 ◽

Author(s):

Jaqueline Driemeyer Correia Horvath ◽

Marina Bessel ◽

Natalia Luiza Kops ◽

Flávia Moreno Alves Souza ◽

Gerson Fernando Mendes Pereira ◽

...

Keyword(s):

Quality Control ◽

Quality Assurance ◽

Quality Indicators ◽

Sampling Errors ◽

Online Data ◽

Monitoring Visit ◽

Multicenter Clinical Trials ◽

Double Entry ◽

And Control ◽

Quality Assurance And Control

BACKGROUND The credibility of a study and its internal and external validity depend crucially on the quality of the data produced. Quality control aims to monitor sampling errors and measurements during the execution of a study and is based mainly on two pillars: planning and standardization of procedures. OBJECTIVE The present article aimed to describe the stages of quality control in the POP-Brazil study and to present an analysis of the quality indicators. METHODS Quality assurance and control included several phases and processes that were initiated with the planning of the study and continued through the development of the project; thus, all centers were trained in loco. RESULTS The data were through a structured questionnaire and collection of biological samples, both performed by more than 250 trained and certified health professionals. Furthermore, to correct possible inadequacies, all 119 centers (public health units) received at least one monitoring visit, which evaluated the professionals' performance and the process of completing the online data platform. The data were monitored daily and were audited through the double entry of data, performed by the central team. The reliability of data was analyzed through the test-retest method, comparing data from the online platform and a second application of the interview, and conducted through telephone, also by the central team. The agreement between the test and retest was considered good (kappa between 0.59 and 0.74). Large multicenter clinical trials are the basis of medical evidence-based and health-based prevention, so their design, logistics, and quality processes should always be carefully considered. CONCLUSIONS This article presents the processes and quality indicators in the POP-Brazil study that allow other studies to generate reliable data.

Download Full-text