Laboratory management, training

The laboratory management shall determine the necessary competence of people working in the laboratoiy and ensure that it is available for the effective and efficient operation of the laboratory. Improvement of people s competence comes through awareness and training. The management of the laboratory should encourage people to... 

Laboratory management must provide for the continuous appraisal, training and development of individuals at all levels in the organizatioa Training and education is, in fact, part of the remuneration package for all level of employees in the laboratory, as well as for self-employed chemists. 

Like the chef the laboratory manager has many constraints in moving forward he cannot merely add staff and cost to the kitchen, he cannot begin to deliver inconsistent product, his responsiveness may not decrease, he cannot achieve quality without well qualified, well trained staff. Instead, he must identify real efficiencies that can be derived from scale. 

The FDA has refrained from specif5ung exactly what scientific disciphnes, education, training, or expertise qualify individuals to participate in the conduct of a nonclinical laboratory study. These factors vary from study to study, and FDA has merely indicated that the question of employee qualifications should be carefully considered by laboratory management. Laboratory management therefore has considerable latitude to define job qualifications. Any reputable laboratory will find it to be in its own best interest to hire competent individuals and to provide adequate on-the-job training to qualify those individuals to perform their assigned duties. The FDA is not likely to make an issue of employee qualifications rniless an inspection reveals an obvious case of employee incompetence. 

The QAP manual must, of course, reflect the efforts of effectively trained and responsible analysts and operators, QA staff, and laboratory management committed to producing reliable results. 

Other areas of inspection focus include sampling protocols, in process controls and specifications, further guidance on the quality of data, computerised systems (more details will be given in the next section), and laboratory management to determine the overall GMP compliance of the facility. This latter area would include supervisory control and review and personnel qualifications and training. 

Documentation of safety and health training for laboratory managers/staff... 

A training program in laboratory security should set out the expectations of management and the need to maintain a safe and secure laboratory environment. Training should be conducted periodically and especially for new personnel. Laboratories should be inspected routinely for compliance with security measures. Personnel working in laboratories should follow all established security procedures, and there should be a protocol for reporting security breaches or security concerns. 

In addition to the plant workers, others may benefit from some special training related to the toll. It may be advantageous or required to consider laboratory personnel, technical support staff, management and others when planning training. Again, the contract may be the way to define this and document responsibility. 

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