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
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.