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FDA Inspections of Outsourcing Facilities

April 6, 2022

2:00 PM - 3:00 PM (Eastern, UTC-4)

This webinar is FREE to attend.

 

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. 

 

TOPICS

  • 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

 

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  • 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

 

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PLEASE NOTE that the app to print your certificate of attendance will become available at the end of the event and will only be available for 2 weeks after the event.

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F D A   R E S O U R C E S

C O N T I N U I N G    E D U C A T I O N    I N F O R M A T I O N

This webinar:

  • has been pre-approved by RAPS as eligible for credits (appropriate to real-time attendance) towards a participant’s RAC recertification upon full completion. There is a maximum of 12 credits per two-day event.
  • 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 1 non-GCP or non-GLP unit 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.

​Real-time attendance is required for attendance certificates which are only available during the two weeks after the event.

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