FDA’s Quality Metrics - Latest Advances

Live Webinar

  • 90 minutes

 There has been a tremendous increase in field alert reports, recalls have increased dramatically, and drug shortages due to component problems, delays, and capacity issues (quality) are increasing as well. Industry itself is ultimately responsible for quality, of course. But while some plants are improving facilities, modernizing control platforms and process technologies, and rolling out quality-by-design (QbD) programs, the facts do not support the idea that there has been real improvement.Industry’s position is “all the FDA cares about is compliance to GMPs [good manufacturing practices]. You don't care about quality.” GMPs do matter and, at least in theory, quality is covered in the GMPs.But the agency is thinking that compliance may have become such a focus that drug makers are not sufficiently concentrating on quality—quality of the process, the batch, the packaging, and the distribution. This lack of focus on quality has resulted in recalls, drug shortages, and other impacts on consumers.To address this issue, FDA has now established an Office of Pharmaceutical Quality to improve the agency’s scrutiny of brand-name, generic, and over-the-counter drugs, and is calling on industry to offer up metrics to prioritize field investigations.

This presentation gives the context for the quality metrics, discusses the draft guidance issued for comment by the FDA and gives the results of FDA and industry discussions to date.

Session Highlights:

•    FDA Centers involved in Quality Metrics

•    The Issue

•    Draft Guidance for Industry: Request for Quality Metrics

  • Background

  • Covered Drugs and Establishments

  • Quality Metrics FDA intends to calculate

  • Optional Quality Metrics that may be submitted

  • How FDA intends to use quality metrics

  • Sections indicated for public comment

•    FDA public meeting

•    FDA Public Meeting results

•    What about CDRH?

•    References

Why You Should Attend:

This is a very important initiative for the FDA who is planning to use the quality metrics as part of their risk based inspection process. Consequently, putting the quality metrics program in place may reduce the inspection frequency at your facility.

This presentation has been created directly from FDA material, using slides from FDA presentations, both internally to the FDA and to the industry at large. Comments from FDA and industry experts have been captured as well, to provide context and deeper understanding for the trainee

Who Should Attend:

  • Quality Managers

  • Quality Engineers

  • Small business owners

  • GxP

  • Consultants

  • Quality VPs

  • IT VPs

*You may ask your Question directly to our expert during the Q&A session.

** You can buy On-Demand and view it as per your convenience.

Angela Bazigos

Angela Bazigos

Angela Bazigos, is the CEO of Touchstone Technologies, Inc. She has 40 years of experience working in hospitals and Pharma industry. Her background includes companies like Roche, Novartis, Genentech and PricewaterhouseCoopers in GLP, GCP, GMP, Medical Device and Data Integrity Roles. She has held positions such as Chief Compliance Officer, QA Director and has acted on behalf CEO for communications with FDA. Ms. Bazigos is a Past President of PRCSQA, a member of the SQA CVIC, ASQ, DIA and RAPS. She works closely with the FDA on behalf of her clients. She consults to Life Science Investment Groups as well as to Pharma / Biotech / Medical Device companies on compliance matters, including strategy, submissions, quality assurance and remediation following action by the FDA. Has contributed to prototyping of 21 CFR 11 & CSV before promulgation to industry. Ms. Bazigos co-authored Computerized Systems in Clinical Research / Current Data Quality and Data Integrity Concepts with FDA, DIA and Academia. She holds a patent in speeding up software validation. She has been on the board for UC Berkeley’s Business School for Executive Education in Life Sciences and is now on the Stanford Who’s Who Registry for contributions to the Life Sciences industry.

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