CDER SBIA Webinar: Overview of the Guidance for Industry - Control of Nitrosamine Impurities in Human Drugs - Oct. 2, 2020

Overview of the Guidance for Industry: Control of Nitrosamine Impurities in Human Drugs

October 2, 2020 | 8:30 a.m. - 10:00 a.m. Eastern | Webcast This webinar is FREE.

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On September 2, 2020, FDA published a guidance for industry entitled Control of Nitrosamine Impurities in Human Drugs. FDA will review the guidance recommendations and industry expectations related to the steps manufacturers of APIs and drug products should take to detect and prevent unacceptable levels of nitrosamine impurities in pharmaceutical products. Additionally, FDA will review the conditions that may introduce nitrosamine impurities and the need for a risk assessment strategy for potential nitrosamines in any pharmaceutical product at risk for their presence.

TOPICS

• Background on Nitrosamines Impurities
• Recommendations to Industry
• Reporting Changes to FDA

INTENDED AUDIENCE

• U.S. and international manufacturers of human drugs for the U.S. market, including manufacturers of prescription and over-the-counter drug products and manufacturers of active pharmaceutical ingredients
• Regulatory affairs professionals working on OTC drugs, compounded products, NDA and ANDA submissions, as well as active pharmaceutical ingredient Drug Master File holders
• Consultants focused on drug manufacturing and quality assurance

CONTINUING EDUCATION

Real-time attendance is required for the certificate of attendance. Certificates are only available during the three weeks post-event. This course:

• has been pre-approved by RAPS as eligible for up to 1.5 credits towards a participant’s RAC recertification upon full completion.
• has been pre-approved by SOCRA who accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate's clinical research therapeutic area.
• has been pre-approved by SQA as eligible for 0.25 non-GCP or non-GLP units for every 1 hour of instructional time towards a participant’s RQAP re-registration.
• has been approved by ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.