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FDA Inspections for Sterile Compounders: The Impact of DQSA

FDA Inspections for Sterile Compounders: The Impact of DQSA

FDA Inspections for Sterile Compounders: The Impact of DQSA

David G. Miller, R.Ph.
David G. Miller, R.Ph.
on behalf of Texas Pharmacy Association

$70.00 $ 70.00 $ 70.00

$70.00 $ 70.00 $ 70.00

$ 70.00 $ 70.00 $ 70.00
$ 70.00 $ 70.00 $ 70.00
Normal Price: $70.00 $70.00

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Launch date: 13 Mar 2017
Expiry Date:

Last updated: 15 Mar 2017

Reference: 172155

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Description

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?

Objectives

Objectives
The learner will deepen their understanding of the FDA Inspections for Sterile Compounder.
David G. Miller, R.Ph.

Author Information Play Video Bio

David G. Miller, R.Ph.
on behalf of Texas Pharmacy Association

David G. Miller, R.Ph. David G. Miller, R.Ph. is the former 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. After receiving his bachelor of science in pharmacy degree from the University of Maryland School of Pharmacy in 1985, he joined the staff of the National.David G. Miller, R.Ph. is the former 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. After receiving his bachelor of science in pharmacy degree from the University of Maryland School of Pharmacy in 1985, he joined the staff of the National Community Pharmacists Association (formerly NARD) as Director of Professional Affairs. In 1988, he accepted a position as Director of Professional Affairs for the Maryland Pharmacists Association and was promoted to serve as that organization’s Executive Director three years later. Miller left the pharmacy association world in 1996 to become the Director of Pharmacy Affairs at Merck where he was responsible for corporate relations with the profession at the national and state level as well as with the academic community.

Current Accreditations

This course has been certified by or provided by the following Certified Organization/s:

  • Accreditation Council for Pharmacy Education (ACPE)
  • 1.00 Hours -
    Exam Pass Rate: 75
    -
    Reference: 0201-9999-16-011-H04-P/0201-9999-16-011-H04-T

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