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Susan Schniepp and Andrew Harrison discuss the requirements for a successful corrective action and preventive action (CAPA) system. Q. I work for a contract manufacturing organization (CMO) and am responsible...

Lisa Michels, General Counsel and regulatory affairs expert at ÃÛ¶¹ÊÓƵ Compliance Associates® Inc., discusses regulatory strategies for software as a medical device (SaMD), artificial intelligence and other emerging technologies. She...

The MDR Delay’s Impact on ÃÛ¶¹ÊÓƵ and Testing—An Orthopedic Innovators Q&A While the recent MDR delay gives companies some breathing room, it should not stall their effort in ensuring their...

Susan J. Schniepp, distinguished fellow at ÃÛ¶¹ÊÓƵ Compliance Associates, addresses the difference between regulatory compliance and real compliance. Q: I just attended a meeting where someone talked about the concept...

Organizations don't perform optimally on the fly, so it's important to prepare and practice the inspection strategy in advance, not simply rely on internal audits to ready the organization.

As Quality Maturity evolves based on the FDA's metrics strategy, it was documented the agency wanted "a maximally efficient, agile, flexible, pharmaceutical manufacturing sector. The goal included high quality drug...