This biannual offers detailed coverage of the regulations, requirements, and techniques for the validation of processes and systems used in regulated international industries. It addresses significant requirements for pharmaceutical, medical device, and biologic companies as well as environmental laboratories. It examines Good Manufacturing Principles (GMPs), Good Clinical Practices (GCPs), Good Laboratory Practices (GLPs), Good Automated Library Practices (GALPs), and others, and elucidates up-to-the-minute industry changes and international concerns.Failure to perform planned and periodic audits of a quality assurance program, in accordance with written audit procedures, by appropriately trained ... For example, the following individuals have not had the appropriate medical device GMP training: (a). ... Automated Blood Grouping Instrument ... in that information contained in the usersa#39; manual for the instrument addresses specimen requirementsanbsp;...
|Title||:||Validation Compliance Biannual 1996-1997|
|Author||:||International Validation Forum|
|Publisher||:||CRC Press - 1996-04-10|