Online Webinar :Current Regulatory and Compliance Trends in the Area of Consent Decree in Pharmaceutical. Medical Device and Biologics
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Deadline: July 28, 2016 | Date: July 28, 2016
Venue/Country: U.S.A
Updated: 2016-06-04 14:12:55 (GMT+9)
Call For Papers - CFP
DESCRIPTIONTopic Background:Many Years Ago Schering Plough underwent the first Consent Decree.Since, then many years elapsed and the term Consent Decree was foreign to many employees and employers and to Industry overall.Over the last Seven Years there has been a Huge Onset of Regulatory Enforcement and Consent Decree Action!!!Description :This webinar will focus on current Food and Drug Administration (FDA) Regulatory Guidance ad well as current Regulatory Trends in regards to specifically Consent Decree. In the recent past there has been an explosion of Regulatory enforcement specifically involving Consent Decree. This webinar will focus on key Quality Systems that are being highlighted in many of the Consent Decree’s, such as Computer Systems Validation (focusing on 21CFR Part 11, Electronic Records and Signatures (ERES), Equipment Qualification, Change Control Systems, Proper Laboratory Investigations, Corrective Action/Preventative Actions (CAPA), Root Cause Analysis (RCA), etc.Overall, this Webinar/Course will provide the attendees with the Ultimate set of Tools in order to help their firms during a Regulatory Inspection as well as helping to avoid falling under Consent Decree Status.Why you should attend the training:This webinar is directed towards executive management. Quality Assurance, Quality Control and Regulatory and Compliance staff who are involved in Consent Decree projects.Objectives of the Topic :Learning about the History of Consent DecreeDiscussing the Schering Plough historical Consent Decree CaseKey Quality System Examples Highlighted in Many Consent DecreesComputer Systems Validation FocusA) 21CFR Part 1B) ERES (Electronic Records and Electronic Signatures)Current Domestic Food and Drug Administration Regulatory TrendsOverall, Current Global Regulatory Enforcement ActivitySummary of Lessons Learned during Regulatory Enforcement/Consent DecreeAreas covered during the Session:Consent Decree DefinitionsCurrent Food and Drug Administration TrendsCurrent Regulatory Enforcement ActivityHistory of Consent DecreeRecent Trends In Consent DecreeConsent Decree Focus on specific Quality SystemsRegulatory Trends Focusing on Computer Systems Validation21CFR Part 11ERES (Electronic Records and Electronic SignaturesCurrent Domestic and International Regulatory TrendsThe following Disciplines will benefit directly from this Webinar :Quality AssuranceQuality ControlRegulatory ComplianceValidationInformation Technology (IT)Laboratory Information Management Systems (LIMS)Research and Development(R&D)Webinar includes:Q/A Session with the Expert to ask your questionPDF print only copy of PowerPoint slides90 Minutes Live PresentationCertificate of attendanceFor Registration :http://c2gowebinars.com/product/?topic=consent-decreeNote: Use coupon code and get 15% off on registration.
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