Staff qualification

For some quants staff is required with different qualifications and fractional numbers (multiple resources). One staff qualification for the setup and one qualification for the production for each quant are taken into account. For certain resources a shift model and also lockup intervals were defined. These constraints may force quants to be enlarged or lengthened over a shift break or lockup interval. This means that within the setup and production intervals of a quant there can... 

Quality assurance—organizational independence, staff qualifications, self-inspection program, AQL, change control procedures, documentation and reports, complaint files, awareness of current regulations, statistical concept employed, batch record turnaround time, etc. 

Staff qualifications and availability The investigators study coordinators (also called research nurses, clinical research coordinators (CRCs), or study nurses) play a key role at the investigational site. Their availability and experience are assessed because they screen and enroll subjects, complete subjects case report forms (CRFs), maintain source documents, follow and assess subjects throughout the study, and have more interactions with the CRA and representatives of the pharmaceutical study during study conduction. 

Additionally, investigations are planned concerning the influence of staff qualification on cycle times. The employment of highly specialized experts in comparison to the employment of workers with broad qualifications (generalists) should be observed. Also, the variation in the weighting of different employee characteristics is to be surveyed. 

Food Drug Administration (2014) Guidance for Industry and FDA Staff Qualification Process for Drug Development Tools (FDA Maryland). 

FDA. (2014a). Guidance for Industry and FDA Staff —Qualification Process for Drug Development Tools. Available at http //www.fda. gov/downloads/drugs/guidancecomplianceregulatoryinformation/ guidances/ucm230597.pdf (accessed October 20, 2015). 

The reputation for quality of a laboratory rests on a number of factors that may include the scientific reputation of the laboratory observed work practices staff qualification and experience a history of satisfactory achievement good results in QA audits and reviews and accreditation to international guides and standards. 

ISO/IEC 17025 1999 Accreditation is the formal recognition of the competence of a body or an organization for a well-defined purpose. In contrast with the ISO 9001 processes, accreditation of a laboratory to ISO/IEC 17025 involves assessment of the technical competence and capability of the laboratory and its personnel. In practice, it is the procedure by which a laboratory is assessed to perform a specific range of tests or calibration measurements. Specific areas examined include infrastructure and staff qualifications, in addition to checks that an adequate quality management scheme is in place. The accreditation covers the range of materials tested or analyzed, the tests carried out, the method and equipment used, and the accuracy or precision expected, and is specific to the facility and the test. 

Insufficient staff qualifications, training, and experience in system safety and risk assessment. 

Technical systems must be adapted to the operational staffs qualification... 

The operational staffs qualification requirements an insufficiently trained staff represents one of the biggest risks. 

WSRC, RSES 109, "Required RSES Employee Training and Technical Staff Qualification," Revision 2. 

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