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Compounding Pharmacies and the USP <71> Sterility Tests

Compounding Pharmacies and the USP <71> Sterility Tests

Compounding Pharmacies and the USP <71> Sterility Tests

Scott Sutton, PhD
Scott Sutton, PhD
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: 171766

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Description

The compendial Sterility Test has a simple premise – test CSP for the presence of viable microorganisms. However, recent regulatory action has highlighted the difficulties in performing the test compliantly. This one-hour webinar will examine the now internationally-harmonized test in terms of its scope as a regulatory requirement and a scientific test method. The discussion will focus on the compendial Sterility Tests (and their Method Suitability requirements) and provide background needed to understand why a harmonized, if admittedly arbitrary, test is so widely required. The discussion will be summarized with a checklist of considerations to review when considering the outsourcing of this important test

Objectives

Objectives
At the conclusion of this program, the pharmacist and technician attendee will be able to:
Describe the critical aspects of the compendial Sterility Tests.
Recognize the need for Method Suitability testing in this application.
Describe the need for proactive documentation.
Explain an audit of a Sterility Test facility and report.
Scott Sutton, PhD

Author Information Play Video Bio

Scott Sutton, PhD
on behalf of International Academy Of Compounding Pharmacists

Dr. Scott Sutton earned his Masters and PhD in Microbiology from the University of Rochester (NY). With over 25 years of laboratory leadership experience in the microbiology arena of the pharmaceutical and personal products industries, he now consults through Microbiology Network, Inc. Clients have included compounding pharmacies, personal care products companies, startups, generics, big pharma companies, law firms and investment broker houses. Laboratory management/design, training, GMP/USP <797>, contamination control and testing methodologies are areas of special interest. Dr. Sutton is a prolific author and speaker who has worked with the USP Microbiology Committee of Experts since 1993. Dr. Sutton is the owner of Microbiology Network, Inc., a consulting company specializing in compliance and contamination control. The Microbiology Network Blog publishes on topics of interest, and the Microbiology Network also supports three Email lists, the first devoted to pharmaceutical microbiology, the second devoted to pharmaceutical stability and the third to compounding pharmacies. Scott tweets on topics of QC Microbiology and GMP Contamination Control as @microbiologynet.

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: 0201-9999-14-114-H04-P/T

Faculty and Disclosures

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Conflicts Declared

Conflicts of Interest declaration by Author:

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