ISO 13485 has undergone its first major overhaul of manufacturing system requirements since 2003. Over the next three years, both the previous requirements and 2016 requirement will co-exist, [...]
Blog Home TAG: EQMS
By Sal LucidoPosted
After decades spent helping companies develop and implement enterprise quality management systems, a consistent pattern has emerged in all effective system implementations. Regardless of [...]
In FDA Regulated Industries, Pharmaceutical Industry, Quality Management, Regulatory Compliance ManagementPosted
After a bit of a lull, the U.S. Food and Drug Administration (FDA) issued a batch of warning letters focused on pharmaceutical manufacturing quality issues in the first quarter of 2017. Examples [...]
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