Webcast | Virtual

Event Title

FDA Inspections of Outsourcing Facilities

April 6, 2022

Date:: April 6, 2022
Time:: 2:00 PM - 3:00 PM ET

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Slides

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

Event Materials

Title	File Type/Size
FDA Inspections of Outsourcing Facilities - April 06, 2022	pdf (597.09 KB)