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FDA Expectations for 503B Outsourcing Facilities

WEBINAR DETAILS

Date: December 11, 2015 (60 minutes)

Featured Speaker:
  • Doyle Smith, Compliance Specialist, Compliance Insight, Inc.

Are 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?

FDA Expectations for 503BThis 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

Keywords: FDA, Outsourcing Facilities

    ABOUT OUR SPEAKER

    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.

    THIS PROGRAM IS INTENDED FOR

    Compounding Pharmacy Owners and Operators

    OUR XTALKS PARTNER FOR THIS EVENT

    INC Research
     

    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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