Live event FDA Auditing Practices and the Top 10 Most Common Cited GMP Deficiencies
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Website https://compliance2go.com/product/?pid=CP2014-415 |
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Category Biotechnology ;Medical Device ;Pharmaceutical
Deadline: February 17, 2015 | Date: February 18, 2015
Venue/Country: Online, U.S.A
Updated: 2015-01-23 17:45:40 (GMT+9)
Call For Papers - CFP
DESCRIPTIONThe success of getting through any audit by federal regulators is not only dependent on a well prepared training of all staff and department employees, but also in knowing what the focus has been of recent inspections within the industry. Such information provides a template for companies to look closely at their own practices in helping to assure similar findings are adequately addressed. In addition, as the audit techniques of the FDA have changed over the years, knowing what to expect can help establish a focused training program as part of the preparation.This webinar will look as changes in the FDA’a approach to audits and the current method used by the agency to determine audit frequencies by using a system of “risk assessments”. The top 10 most cited GMP deficiencies over the last year will be reviewed along with the significant increase in the number of warning letters issued over the last 4 years. Actual case examples will be used to highlight various points discussed and attendees will get a chance to ask questions throughout the presentationWhy you should attend:This webinar will provide the attendees with a better understanding of the current audit techniques used by the FDA and how they have changed over the years. Additionally, the webinar will provide a template that companies can use to evaluate their own state of compliance by knowing what have been the most common cited GMP deficiencies over the last year.Areas Covered In the Seminar:Changes in FDA audit approaches Most common cited GMP deficiencies for 2011-2012Increase in FDA enforcement actionsWho will benefit:Quality AssuranceQuality ControlManufacturingProductionRegulatoryLaboratory PersonnelManagementWebinar Includes:Q/A Session with the Expert to ask your questionCopy of PowerPoint slides (PDF print only)90 Minutes Live PresentationCertificate of Attendance
Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
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