FDA Expectations for 503B Outsourcing Facilities

Life Sciences, Pharmaceutical Regulation, Pharmaceutical, Pharma Manufacturing & Supply Chain,
  • Friday, December 11, 2015

businessman and businesswoman are inspecting contractAre you a compounding pharmacy considering whether to register with the FDA as an Outsourcing Facility? Are you already an outsourcing pharmacy wondering why so many 503B facilities are receiving FDA Warning Letters?

This discussion is built around the most pressing issues affecting the
Compounding Pharmacy/ Outsourcing Industry:

  • FDA 483/Warning Letter
  • Sterile Area Expectations
  • Quality System
  • Standard Operating Procedures
  • Quality Training
  • 503B Registration Filing
  • Process/Equipment Validation


Doyle Smith, Compliance Specialist, Compliance Insight, Inc.

An experienced Compliance Assurance professional with a diverse background, with over 24 years as a FDA employee and over 20 years’ experience in the Pharmaceutical industry, having an in-depth knowledge and experience in the application and evaluation of GXP regulations. Possessing a broad based knowledge of the FD&C law and implementing regulations with extensive experience in the application of cGMP and GCP regulations / guidance in the establishment of drug development manufacturing, packaging and testing, investigations, document review and evaluation and auditing. As well as, training, and participating on multidisciplinary teams. Responsible for the planning and audit execution of the audit programs; organizing and leading people and projects to produce timely results. A self-motivated individual who is a team player and enjoys a challenging work environment.

Message Presenter

Who Should Attend?

Compounding Pharmacy Owners and Operators

Xtalks Partner

Compliance Insight

Compliance Insight offers hands-on compliance, quality assurance, clinical and regulatory affairs guidance and consulting that is reliable, accurate, timely and supportive of the client’s goals and compliant with US FDA Regulations.

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