CONFERENCE SPOTLIGHT

CDRH Reorganization Takes a Total Product Lifecycle Approach; MDSAP, ISO Adoption, and Collaboration with MDIC Moving Forward

In the third report from December’s FDLI Enforcement, Litigation, and Compliance Conference, CDRH’s Associate Director for Compliance and Quality Erin Keith explains the Center’s completely revamped organization structure that was finalized late last Fall, its progress on international harmonization efforts, and the changing face of its compliance program.

GMP Compliance for Legacy Products: How to Find and Avoid Potential Quality Issues

FDA-regulated firms face an enormous challenge keeping up with agency priorities and expectations—especially companies that produce older products within an ever-changing regulatory landscape.  While firms continue to manufacture these older products to serve their customers and protect their brand, there are many potential quality compliance issues that can arise.

How Key Pharma and Device Executives Are Developing the Next Generation of Quality Professionals and Leaders

A team comprising over a dozen chief quality officers (CQOs) representing the medical device, pharmaceutical, animal health, and consumer healthcare industries has pooled its collective passion and wisdom – with input from FDA and other drug and device regulatory agencies – to establish and implement an innovative education curriculum that will help develop the next generation of scientists entering the industry.

CDRH Reorganization Takes a Total Product Lifecycle Approach; MDSAP, ISO Adoption, and Collaboration with MDIC Moving Forward

In the third report from December’s FDLI Enforcement, Litigation, and Compliance Conference, CDRH’s Associate Director for Compliance and Quality Erin Keith explains the Center’s completely revamped organization structure that was finalized late last Fall, its progress on international harmonization efforts, and the changing face of its compliance program.

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FDA Warning Letters Week of 3/22/2020: OTC and HCT/P

In the areas we cover, FDA posted three drug GMP warning letters including one sent to a fertility clinic governed by HCT/P regulations.  The other two firms manufacture OTC products.  FDA also posted a warning letter to a firm in Ireland, Carahealth, for distributing unapproved and misbranded products related to coronavirus disease.

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EMA Announcements Regarding Nitrosamine and MDRs

The EMA published information on two topics this week addressing changes in due dates and application dates regarding nitrosamine-related risk assessments and implementation of the new Medical Device Regulation (MDR) requirements.

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Part 3: MHRA GMP Inspection Deficiencies for 2018

Published in late 2019, MHRA’s 2018 GMP inspection deficiency data spans over 6,000 lines of a spreadsheet. GMP expert Barbara W. Unger evaluated the data and presents a data-dense report of her findings and deficiency trends since 2015.

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