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Current Regulatory and Compliance Trends in the Area of Consent Decree
Wednesday
01.00 PM
http://c2gowebinars.com/product/?topic=consent-decree
10777 Westheimer Suite 1100, Houston, Texas, USA,
Houston Texas 77042
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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????and?get?15% off?on?registration.
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David
Phone: 8777824696
8777824696
Email: subscribe (at) compliance2go.com |
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