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Responses to internal audit reports are critical for GMP compliance because they fall under CAPA — so how a company responds to the findings of an internal audit is a key component of an effective audit. Read More
South Africa’s Medicines Control Council (MCC) released a draft guideline listing minimum requirements for quality manuals that medical device importers, manufacturers, distributers, exporters, and wholesalers must maintain. Read More
The FDA issued warning letters to four medical device firms citing serious CAPA and other violations, including inadequate complaint response, quality testing, and verification of shipping and packaging methods to ensure product integrity and sterility. Read More
Congress reached a deal on a comprehensive, 1,600-page bill to fund the federal government through September 30 – and give the FDA an extra $39 million. Read More
The most common error companies make when conducting internal audits is to take a confrontational approach when fixing them, according to one compliance expert. Read More
Beginning Sept. 1, companies that put their names on devices made by other companies must have their quality management systems (QMS) audited and full technical documentation reviewed by notified bodies, says new guidance from the UK’s MHRA. Read More
The European Union’s new Medical Device Regulation (MDR) will create significant compliance headaches for manufacturers — including new harmonized standards, classification rules, and conformity assessment procedures. Read More