1987 Web-based Seminars

FDAs New Process Validation Guidance - Webinar By GlobalCompliancePanel ...heir antiquated General Principles of Process Validation (1987), in January 2011 FDA finally published the official standard. While technically"guidance," FDA has indicated they will enforce compliance rigorously. This complete overhaul of FDA's primary validation standard brings U. S. drug. API, and biologics process validation up to par with the advanced and modern expectations of European  more...

Process Validation for Medical Devices - Webinar By GlobalCompliancePanel ...eral Principals of Process Validation" was issued in May, 1987, and since then, medical device companies have struggled with process validation. Regulators believe through careful design and validation of the process, a manufacturer can establish a high degree of confidence that all manufactured units from successive lots will be acceptable. Successfully validating a process reduces the  more...