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    Online Webinar :Current Regulatory and Compliance Trends in the Area of Consent Decree in Pharmaceutical. Medical Device and Biologics

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    Website http://c2gowebinars.com/product/?topic=consent-decree | Want to Edit it Edit Freely

    Category

    Deadline: July 28, 2016 | Date: July 28, 2016

    Venue/Country: Online, U.S.A

    Updated: 2016-06-11 14:13:08 (GMT+9)

    Call For Papers - CFP

    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.


    Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
    Disclaimer: ourGlocal is an open academical resource system, which anyone can edit or update. Usually, journal information updated by us, journal managers or others. So the information is old or wrong now. Specially, impact factor is changing every year. Even it was correct when updated, it may have been changed now. So please go to Thomson Reuters to confirm latest value about Journal impact factor.