Now viewing a bundle in: CE Catalog
FDA Inspections: The Impact of DQSA Bundle
Published by International Academy of Compounding Pharmacists



Summary
Save $5 when you purchase these two programs together!

Programs Included in this Bundle
  1. FDA Inspections for Compounders: The Impact of DQSA
    In the past, compounding pharmacies were inspected by the FDA based on a complaint or a medication error. With the enactment of the Drug Quality & Security Act after the NECC tragedy, the FDA is taking a different approach -- a risk-based plan to thoroughly inspect compounders. Are you prepared for an FDA inspection? Do you know what your responsibilities and rights are? Does your staff understand what is expected of them? This educational seminar will give you the tools to assess and prepare for an inspection as well as to understand the areas in which the FDA is most interested.

    Accreditation Information:
    This lesson is a knowledge-based CE activity and is targeted to pharmacists and technicians.

    ACPE logo The American College of Apothecaries (ACA) is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. ACA has accredited this program for 1.0 contact hours (0.1 CEUs) of continuing education credit for pharmacists and technicians. 0201-9999-15-139-H03-P; 0201-9999-15-139-H03-T.

    If you are interested in earning credit for this program, please note that you will be asked to enter your NABP e-Profile ID during the credit selection step of the registration process. If you have not yet registered your NABP e-Profile ID, please visit www.nabp.net.

    CE credit and certificates of attendance will be provided only to those individuals who registered and logged into the webinar online. If you want CE credit and your certificate of attendance, you must have purchased the program and logged into the web portion under that registration so that we can verify attendance.

    Learning Objectives:
    At the conclusion of this program, the pharmacist and technician attendee will be able to:

    • Explain the legal basis for inspections of pharmacies by the Food & Drug Administration (FDA).
    • Discuss the rights and responsibilities of pharmacy staff during an FDA inspection of a compounding pharmacy.
    • Identify key inspection findings from Form 483 reports.
    • List three action items to prepare a compounding pharmacy for an FDA inspection.


    This seminar includes the following components:
    • FDA Inspections for Compounders: The Impact of DQSA - Video
    • FDA Inspections for Compounders: The Impact of DQSA - Audio
    • FDA Inspections for Compounders: The Impact of DQSA - Handout
    • FDA Inspections for Compounders: The Impact of DQSA - Q&A

    Credit
     Click on jurisdiction for specific details  


  2. FDA Inspections for Sterile Compounders: The Impact of DQSA
    Office-Use + FDA = cGMP
    That’s a heck of an equation! The Food and Drug Administration is directing its inspectors to find one… just one… instance of an office-use compound to justify allegations that a compounding pharmacists isn’t eligible for the exemptions provided for within section 503A of the Food, Drug and Cosmetic Act. And without those exemptions any compounder can then be held to Current Good Manufacturing Standards.

    If you are a sterile compounder, understanding the approach and the areas which FDA inspectors are told to check is absolutely critical. For example, did you know that you are expected to validate and document the efficacy of your disinfectant? that you are supposed to audit your testing laboratory? that you must have SOPs to demonstrate assessments of the sterility of your containers and your container closures?

    The American College of Apothecaries (ACA) is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. ACA has accredited this program for 1.0 contact hours (0.1 CEUs) of continuing education credit for pharmacists and technicians. 0201-9999-15-141-L03-P; 0201-9999-15-141-L03-T.

    If you are interested in earning credit for this program, please note that you will be asked to enter your NABP e-Profile ID during the credit selection step of the registration process. If you have not yet registered your NABP e-Profile ID, please visit www.nabp.net.

    CE credit and certificates of attendance will be provided only to those individuals who registered and logged into the webinar online. If you want CE credit and your certificate of attendance, you must have purchased the program and logged into the web portion under that registration so that we can verify attendance.



    This seminar includes the following components:
    • FDA Inspections for Sterile Compounders: The Impact of DQSA - Video
    • FDA Inspections for Sterile Compounders: The Impact of DQSA - Audio
    • FDA Inspections for Sterile Compounders: The Impact of DQSA - Paper
    • FDA Inspections for Sterile Compounders: The Impact of DQSA - Q&A

    Credit
     Click on jurisdiction for specific details  



Refund Policy
SeminarWeb and International Academy of Compounding Pharmacists programs are non-refundable.

Privacy Statement
We respect and are committed to protecting your privacy. (Read Statement)


Powered by
Powered by SeminarWeb.com