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Visit CDER Small Business and Industry Assistance Page

ABOUT THIS WEBINAR

During this webinar, FDA will:

• Provide an overview of the inspection process for compounding outsourcing facilities.
• Discuss what to expect during an inspection, from initiation to closeout as well as observations on successes and challenges.

INTENDED AUDIENCE

• Compounding outsourcing facilities
• Compounding pharmacies with interest in the outsourcing facility sector and FDA compounding inspections
• State pharmacy regulators
• Consultants focused on outsourcing facilities and compounding pharmacies
• FDA-regulated industry or general public with an interest in the inspections process for compounding pharmacies and outsourcing facilities

TOPICS COVERED

• Current Good Manufacturing Practices (CGMPs) for Outsourcing Facilities
• Insanitary conditions
• Initial facility walk-through
• Aseptic operators and operations
• Process and facility design
• Cross contamination
• Environmental and personnel monitoring
• Product inspection and component control
• Packaging and labeling control
• Records review
• Evaluation of compliance with section 503B of the FD&C Act

FDA SPEAKERS

Jessica Pressley McAlister
Pharmacy Compounding National Expert
Division of Pharmaceutical Quality Programs (DPQP)
Office of Pharmaceutical Quality Operations (OPQO)
Office of Regulatory Affairs (ORA) | FDA

Lori Cantin, PharmD, MS, RPh
Captain, U.S. Public Health Service
Branch Chief, Branch 3
Division of Compounding II
Office of Compounding Quality & Compliance (OCQC)
Office of Compliance (OC)
Center for Drug Evaluation and Research (CDER) | FDA

FDA RESOURCES

• Regulatory Policy Information | FDA
• Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice
• Human Drug Compounding
• Compounding Quality Center of Excellence | Training Programs

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.
• 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.
• pre-approved by 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.
• approved by 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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• Please contact [email protected] for all technical questions.
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