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Corrective and Preventative Action – or CAPA. Sometimes the mere mention of this can send pharmaceutical companies and their staff into panic mode, especially if it comes on the heels of a 483 warning letter.
With everyone scrambling to evaluate how quality issues – whether in the lab or as part of the manufacturing process – can be addressed, they tend to hit the panic button. Rushed decisions ensue, and then teams are scrambling to find alternate methods of meeting FDA requirements in a shortened timeframe.
But it doesn’t have to be this way.
Lately, cyber criminals seem to be zeroing in on high-profile corporations, such as JPMorgan Chase, Home Depot, Dairy Queen and many others. So it begs the question: If these large companies – many of whom spend millions to protect their information security – are so vulnerable, how can individuals better protect themselves from the wrath of hackers?
Instrument qualification is a required process by many national and international pharmaceutical industry regulations and quality standards to ensure data validity and ultimately, a quality consumer product.
Looking to expand its presence in Pennsylvania, Syndicus has added State College as one of its business locations.
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