FDA Documents, Statements Prioritize the ‘P’ in CAPA: Expert
Quality personnel at drug companies often express confusion about how an effective CAPA program should be designed, citing the lack of a singular go-to guidance document or manual.
As a result, CAPA issues are routinely cited in warning letters year after year.
The quality of pharma products and good manufacturing practices (GMP) are in the s FDA’s crosshairs, and a top priority during inspections. Drug GMP Report has provided thorough analysis and interpretation of ever-changing GMP regulations, FDA enforcement trends and warning letters, international regulations and more. It’s akin to receiving a monthly executive briefing packed with the latest on inspection hot spots, developments in certification procedures, electronic data requirements and evolving trends in drug GMP enforcement.
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