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ABOUT THIS EVENT

During this webinar FDA will provide an overview of drug manufacturing inspections. Participants will gain a general understanding of Current Good Manufacturing Practices (CGMPs) and FDA Inspections. FDA subject matter experts will also demonstrate where inspection data is found on FDA’s website and share how to navigate the FDA Inspection Dashboard.

INTENDED AUDIENCE

• Regulatory science and regulatory affairs professionals
• Healthcare organizations that purchase pharmaceuticals

TOPICS COVERED

• Overview of FDA’s CGMPs and Inspection Practices
• How to Find FDA Inspectional Findings

SPEAKERS | PANELISTS

Applicable Manufacturing Standards
Jennifer Maguire
Director, Office of Quality Surveillance (OQS)
Office of Pharmaceutical Quality (OPQ)
Center for Drug Evaluation and Research (CDER)
FDA

Understanding CGMP Inspections and 483s
Simone Pitts
Pharmaceutical National Expert
Office of Regulatory Affairs (ORA) | FDA

FDA Regulatory Actions & How FDA Reviews Inspectional Findings
Francis Godwin
Director, Office of Manufacturing Quality (OMQ)
Office of Compliance (OC) | CDER | FDA

Where to Find Inspection & Other Compliance Documents
Darshini Satchi
Deputy Director, Division of Information Disclosure Policy (DIDP)
Office of Regulatory Programs (ORP) | CDER | FDA

FDA Inspections Dashboard Demo
Rob Bughman
Project Manager, FDA Inspection Dashboard
ORA | FDA

FDA RESOURCES

• CDER Reading Room
• ORA Reading Room
• FDA Warning Letter Page
• FDA Inspections Dashboard
• FDA CGMP Inspection Related Import Alert
• Enforcement Reports

CONTINUING EDUCATION

Real-time attendance is required for the certificate of attendance which can be used in support of CEs for the following professional organizations. Certificates are only available during the two weeks post-event.

This course has been pre-approved by:

• RAPS as eligible for a maximum of 12 credits for a two-day event (appropriate to real-time attendance) towards a participant’s RAC recertification upon full completion.
• 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.
• SQA as eligible for 1 non-GCP or non-GLP unit for every 1 hour of instructional time towards a participant’s RQAP re-registration.
• ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.

TECHNICAL INFORMATION

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