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DTSTART;TZID=America/Los_Angeles:20251106T084500
DTEND;TZID=America/Los_Angeles:20251106T173000
DTSTAMP:20260603T182629
CREATED:20251014T192722Z
LAST-MODIFIED:20251014T192722Z
UID:10000914-1762418700-1762450200@www.califesciences.org
SUMMARY:Good Laboratory Practices (GLPs) and Good Manufacturing Practices (GMPs) in Drug Development: Fundamentals\, Regulatory Trends and Best Practices
DESCRIPTION:This workshop will be conducted in two sessions: \nI. Good Laboratory Practices (GLPs): Fundamentals\, Regulatory Trends and Best Practices \nThis section includes a discussion on the history of Good Laboratory Practices (GLP) regulations\, the importance of the regulations\, key definitions\, areas covered by the GLPs\, a review of the regulations\, examples of misconduct and\, potential FDA actions. After completing this workshop\, participants should be able to understand the origin\, purpose\, and expectations of the GLP regulations. \nList of Topics \n\nGeneral Provisions\nOrganization and Personnel\nFacilities and Equipment\nTesting Facilities Operations\nTest and Control Articles\nRecords and Reports\nDisqualification\nFDA Actions and Misconduct\n\nII. Good Manufacturing Practices (GMPs) from R&D through Commercialization: Fundamentals\, Regulatory Trends and Best Practices \nThis section includes a discussion on the history of Good Manufacturing Practices (GMP) regulations from R&D through Commercialization\, key definitions\, areas covered by the GMPs\, a review of the regulations\, examples of misconduct and\, potential FDA actions. After completing this workshop\, participants should be able to understand the origin\, purpose\, and expectations of the GMP regulations. \nList of Topics \n\nBasis of GMPs\nCGMPs on a continuum\nCurrent FDA Expectations and Focus\nOversight of CMOs\n\nREGISTER» \nHosted by:
URL:https://www.califesciences.org/event/glps-and-gmps-in-drug-development/
LOCATION:Hilton Garden Inn San Mateo\, 2000 Bridgepointe Cir\, San Mateo\, CA\, 94404\, United States
CATEGORIES:Industry Events,Industry Supported
ATTACH;FMTTYPE=image/jpeg:https://www.califesciences.org/wp-content/uploads/2025/01/Industry-Event.jpg
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