Author: Judy Carmody

    Judy Carmody, PhD – Founder and Principal Consultant, Carmody Quality Solutions, LLC. Affiliations: Member, Society of Quality Assurance (SQA), New England Regional Chapter Society of Quality Assurance (NERCSQA), Association of GXP Excellence (AGXPE), and Women in Bio   A Roadmap to Quality: Performing CMC Activities with an NDA In Mind Oligonucleotide therapeutics development continues…

By Judy Carmody, Ph.D., Carmody Quality Solutions, LLC As we close out 2020, which can’t come soon enough, it is fitting to look at how to build a voluntary quality culture in our “new normal” work environment. I don’t need to tell anyone in a quality role how COVID plans and precautions have added an entire…

How people take steps to institutionalize a Voluntary Quality Assurance (VQA)® Culture in their organization. We explore a blog post by the FDA’s Janet Woodcock and developing a new quality rating system to bring transparency to life sciences.

Maintaining quality is everyone’s job and a team effort. And when it is overlooked, bad things happen.

Equipment qualification, including software validation for automated systems, is the process of demonstrating that equipment performs as intended. “As intended” is truly the key part of this process …

At a workshop … the organizer gave us an exercise tied to new requirements from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E6(R2) — study risks versus system risks. … Many individuals sat with dazed looks, in a dull panic, not sure where to begin.

When he was home for the holidays, my 23-year-old son and I had intense, heated discussions about generational differences. We are still on speaking terms, but it got me thinking about how well we understand and value young people…

An article examining recent GMP inspection data from two prominent regulatory bodies notes that “Deficiencies in investigations remains at the top of this list over the past four years. We as an industry cannot seem to get this quite right.” I agree. Here’s why.

A well-managed stability program with thoughtfully constructed protocols demonstrates your lab and quality systems are in control.

… of the 40 GMP warning letters issued by FDA for data integrity deficiencies in 2015, 12 (30%) referenced training issues or requirements.

The U.S. Food and Drug Administration (FDA) cites corporate culture as a root cause of many compliance issues. It also says a strong quality culture “can lead to sustainable compliance.”