In today’s competitive environment it is the objective of all life science manufacturing companies to minimize the risks of compliance non-conformance and the significant associated post-event costs. These costs are seen in human resource non-production time allocations, production delays or halts, and ultimately shut downs and product recalls with potential fines or consent decrees. The ultimate costs will be seen in the potential impacts to patients. These costs can mount into the hundreds of millions of dollars and, as such, should be at the forefront of boardroom discussions. REDUCE COMPLIANCE RISK WITH A PROCEDURE MANAGEMENT SOLUTION WhitepaperINTRODUCTION The total number of Form 483s issued using FDA tools for Drug Inspections in increased again in 2019, reaching 779 for the

Join for free to read