FDA’s Quality Metrics - Latest Advances

01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 90 Minutes

Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar

"Hear By Angela Bazigos who recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom"

For the quality metrics, discusses the draft guidance


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This presentation gives the context for the quality metrics, discusses the draft guidance issued for comment by the FDA and gives the results of FDA and industry discussions to date.

Why should you 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

Areas Covered

•           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•           Draft Guidance for Industry: Request for Quality Metrics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

Who will Benefit

•           Quality Managers
•           Quality Engineers
•           Small business owners
•           GxP
•           Consultants
•           Quality VPs
•           IT VPs

Industries who can attend

This 90-minute online course is intended for professionals in the Pharmaceutical, Clinical Data Management SaaS companies, and medical device companies . Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.

Speaker Profile

Angela Bazigos

Angela Bazigos.CEO of Touchstone Technologies Inc. She has 40 years of experience in the Life Sciences & Healthcare Industries. Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety, Turnarounds and Business Development. Past employers / clients include Roche, Novartis, Genentech & PriceWaterhouseCoopers. Positions include Chief Compliance Officer at Morf Media. Co-authored & prototyped 21 CFR 11 guidance with FDA.  Co-authored Computerized Systems in Clinical Research w/ FDA. Patent on speeding up software compliance. Recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom. National Trainer for Society of Quality Assurance. Comments / collaborates with FDA on new guidance documents. Former President of Pacific Regional Chapter of Society of Quality Assurance. Stanford’s Who’s Who for Life Sciences.

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