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Webinar: FDA Inspections for Compounders: The Impact of DQSA
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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? 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.

10/6/2015
When: Tuesday October 6th
11-12 PM
Where: Webinar
Presenter: David G. Miller, R.Ph.
Contact: 425-228-7171 ext: 0

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To Register:
https://ce.wsparx.org/index.cfm?pg=semwebCatalog&panel=showLive&seminarid=6423

 
FDA Inspections for Compounders: The Impact of DQSA

Summary
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-L03-P; 0201-9999-15-139-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.

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.

 

David G. Miller, R.Ph.
David G. Miller, R.Ph. is Executive Vice President and Chief Executive Officer of the International Academy of Compounding Pharmacists. IACP represents more than 4,000 practitioners and 163,000 consumers who recognize the value of customized medication solutions provided by the art and science of pharmacy compounding.

 

How To Attend
Join the live program from your office, home, or hotel room using a computer with high speed internet. You may ask questions, participate in surveys, and post comments from your computer during the program. Please note that credit (if available) is only provided to registered attendees participating at their own computer and phone. Simple instructions with a link to the program will be sent when you register and again the day before the webinar.

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Credit
If applicable, you may obtain credit in multiple jurisdictions simultaneously for this program (see pending/approved list below). Registrants in jurisdictions not listed below will receive a Certificate of Attendance/Completion that may or may not meet credit requirements in other jurisdictions. Where applicable, credit will be only awarded to a paid registrant attending the live program at their own computer and phone.

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