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Compounding Pharmacies and Investigations
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2/18/2015
When: 2/18/2015
12:00 PM
Where: Live Webinar
Live Webinar
Presenter: Scott Sutton
Contact: 800-632-8822


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THIS IS A LIVE WEBINAR FOR 1 CE HOUR, OPEN TO PSSNY MEMBERS ONLY  

Goals and Objectives:

Expectations for investigations of failed batches, environmental excursions and other untoward events will be discussed. The source document for this will be FDA’s guidance document “Guidance for Industry: Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production” (2006).  Investigations of failed CSP testing, issues in the field and the pharmacy’s response continue to be a source of concern for regulators.  Appropriate investigation and follow through are critical to maintain your pharmacy’s standing.

At the completion of this presentation the learner will:

·         Understand the basis and format for a compliant investigation

·         Be able to describe and implement investigations in response to

o   Environmental excursions

o   Failed CSP release test results

o   CSP returned from the field

Length of Program:  60 minutes

Presenters Biography

 

The Pharmacists Society of the State of New York is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy educations. To receive CE credit a passing grade of 80% must be attained. CE credit for successfully completed quizzes will be uploaded to the CPE Monitor.