Current Regulatory and Compliance Trends in the Area of Consent Decree in Pharma
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| Description: | DESCRIPTION Topic 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 Decree Discussing the Schering Plough historical Consent Decree Case Key Quality System Examples Highlighted in Many Consent Decrees Computer Systems Validation Focus A) 21CFR Part 1 B) ERES (Electronic Records and Electronic Signatures) Current Domestic Food and Drug Administration Regulatory Trends Overall, Current Global Regulatory Enforcement Activity Summary of Lessons Learned during Regulatory Enforcement/Consent Decree Areas covered during the Session: Consent Decree Definitions Current Food and Drug Administration Trends Current Regulatory Enforcement Activity History of Consent Decree Recent Trends In Consent Decree Consent Decree Focus on specific Quality Systems Regulatory Trends Focusing on Computer Systems Validation 21CFR Part 11 ERES (Electronic Records and Electronic Signatures Current Domestic and International Regulatory Trends The following Disciplines will benefit directly from this Webinar : Quality Assurance Quality Control Regulatory Compliance Validation Information Technology (IT) Laboratory Information Management Systems (LIMS) Research and Development(R&D) Webinar includes: Q/A Session with the Expert to ask your question PDF print only copy of PowerPoint slides 90 Minutes Live Presentation Certificate of attendance For Registration : http://c2gowebinars.com/product/?topic=consent-decree Note: Use coupon code < T9AIO8AY> and get 15% off on registration. |
| URL: | http://c2gowebinars.com/product/?topic=consent-decree |
| Date: | Wednesday, March 16, 2016 |
| Time: | 5:00pm-6:30pm UTC |
| Duration: | 1 hour 30 minutes |
| Access: | Public |
| Created by: | Public Access |
| Updated: | Monday, February 22, 2016 8:27am UTC |
| : | $179 |
| : | (877) 782-4696 |
| : | subscribe@compliance2go.com |
| : | David |
| : | 8777824696 |
| Comments: | None |