A company’s Corrective and Preventive Action (CAPA ) system establishes how personnel should deal with manufacturing problems that have occurred or that may occur if not prevented. This module explains the principles of corrective and preventive action and describes typical CAPA procedure. It goes on to introduce root cause analysis and outline the role of progress tracking, escalating, and trending of CAPA procedures.
This module describes the requirements that must be met to obtain licensure of a biological product. Subjects covered include the regulatory context, the content and format of the BLA submission, the review process, and provisions for expedited development and review.
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Want to make electric lamps, but not sure about the wiring, regulations and so on? If you can make the lamp base (in clay, wood, glass metal or whatever), then this course tells you how to do the rest.
In this short course we present an overview of the main principles of GMP, and we outline some things that manufacturing personnel need to do to comply with requirements. We identify the principal goals of GMP as: prevention of contamination; prevention of mix-ups; scrupulous documentation; validation and maintenance of processes and equipment; quality assurance by an independent unit; and training. We place GMP in the context of a company’s quality management system.