This electronic learning course discusses the personnel and physical infrastructure aspects associated with operating a laboratory in either a regulated (cGLP or cGMP) or accredited (ISO 17025) environment. This will include:
The management structure required to conform with regulatory or accreditation requirements and will include a discussion of the functions of each the departments within the laboratory organisation
In the roles and responsibilities of the key personal within the laboratory we will discuss the key functions and responsibilities of the different members of staff, and also look at training requirements
The facilities and infrastructure needed in a modern analytical laboratory to comply with the requirements of current Good Laboratory Practice (cGLP). This will also include a discussion of requirements to assure the laboratory facilities and infrastructure are suitable for their intended purpose
This course concludes with an assessment for which a certificate is issued upon successful completion which meets Pharmaceutical EU / PIC/S GMP requirements.