CDER SBIA Webinar: Draft Guidance for Industry: Request for Quality Metrics

CDER Small Business and Industry Assistance (CDER SBIA) Webinar - Draft Guidance for Industry: Request for Quality Metrics - July 27, 2015

FDA has issued Request for Quality Metrics draft guidance for industry on a quality metrics reporting program and is asking industry, stakeholders, and the public to submit comments to this guidance. The agency also announced an Aug. 24, 2015 public meeting to seek input on this topic

CDER SBIA is making available the accompanying webinar which will provide an overview of the draft guidance in order to solicit comments and feedback at the upcoming public meeting via the docket.

Quality metrics are used throughout the pharmaceutical industry to continually monitor the performance of manufacturing processes and quality systems and drive continuous improvement efforts in drug manufacturing.

These metrics can also be used by FDA:

- to encourage the pharmaceutical industry to implement state-of-the-art, innovative quality management systems for pharmaceutical manufacturing.

- to improve regulatory review, compliance, and inspection policies and practices, such as risk-based inspection scheduling of drug manufacturers.

- to improve FDA’s ability to forecast potential disruptions to the drug supply while identifying quality issues that may lead to drug shortages

Speaker:

Janet Woodcock, MD

Director Center for Drug Evaluation and Research (CDER), FDA

And Acting Director Office of Pharmaceutical Quality (OPQ), CDER, FDA

As of January 2015, Dr. Woodcock also assumed the role of Acting Director of CDER’s newly formed Office of Pharmaceutical Quality, (OPQ). Dr. Woodcock first joined CDER in 1994.

Speaker:

Karthik Iyer

Acting Branch Chief

Quality Intelligence Branch (QIB)

Office of Surveillance (OS)

Office of Pharmaceutical Quality (OPQ), CDER, FDA

Speaker:

Alex Viehmann

Operations Research Analyst

Quality Intelligence Branch (QIB)

Office of Surveillance (OS)

Office of Pharmaceutical Quality (OPQ), CDER, FDA

The main responsibilities of the Quality Intelligence Branch are to design and implement the Quality Metrics Program, and to provide drug manufacturing applied statistics support to CDER and the Office of Regulatory Affairs (ORA.)

For questions concerning the webinar, please contact CDER SBIA at:

(866)-405-5367 | (301)-796-6707

The Small Business and Industry Assistance program in the Center for Drug Evaluation and Research (CDER SBIA) provides guidance and information to regulated domestic and international small pharmaceutical business and industry through its website, email notifications, and workshops. This notification system provides current information from CDER/FDA via e-mail on a biweekly basis that is relevant to small pharmaceutical business, which includes Federal Register notices, guidances, workshop announcements, etc. This is an automated message delivery system. Replying to this message will not reach the CDER SBIA staff. If you have comments or questions, please contact us Monday through Friday 8:00AM - 4:30PM.

• Email: CDERSBIA@fda.hhs.gov
• Phone: 1-866-405-5367
• Phone: (301) 796-6707
• Website: http://www.fda.gov/cdersbia