Saving changes...

Done

Error

FDA Inspections for Compounders: The Impact of DQSA

FDA Inspections for Compounders: The Impact of DQSA

FDA Inspections for Compounders: The Impact of DQSA

David G. Miller, R.Ph. And David G. Miller, R.Ph.
David G. Miller, R.Ph. And David G. Miller, R.Ph.
on behalf of International Academy Of Compounding Pharmacists

$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

Review:

Launch date: 10 Mar 2017
Expiry Date:

Last updated: 13 Mar 2017

Reference: 171787

This course is no longer available

Exam is embedded in the course
No preview available
No Exam Available

Latest User Comments

I would like to...

Course Availability

This course is only available to trainees days after purchase. It would need to be repurchased by the trainee if not completed in the allotted time period. This course is no longer available. You will need to repurchase if you wish to take the course again.

You have null days left.

Description

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.

Objectives

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. And David G. Miller, R.Ph.

Author Information Play Video Bio

David G. Miller, R.Ph. And David G. Miller, R.Ph.
on behalf of International Academy Of Compounding Pharmacists

David G. Miller, R.Ph. is the former Executive Vice President and Chief Executive Officer of the International Academy of Compounding Pharmacists. IACP represents 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: 0201-9999-15-139-H03-P/T

Faculty and Disclosures

Additional Contributors

null

Conflicts Declared

Conflicts of Interest declaration by Author:

null

User Reviews (0)

Go Back

Loading...


Saving changes...

Done

Error