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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)
 
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