Implementing a Quality Systems-Based Approach to GCP Compliance - Webinar By GlobalCompliancePanel by globalcompliancepane


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    RAPS Approved Webinar                   on
      Implementing a Quality Systems-Based Approach to GCP Compliance

    Date & Time:                                                                                                                    

     Course "Implementing a Quality Systems-Based Approach to
     GCP Compliance" has been pre-approved by RAPS as eligible
                                                                                              Register Now                          

     for up to 1.00 credits towards a participant's RAC recertification
     upon full completion.

                                                                                         Instructor Profile:

     Tuesday, August 7, 2012              10:00 AM PDT | 01:00 PM EDT
                                                                                                       Amnon Eylath
     Duration: 60 Minutes                 Instructor: Amnon Eylath                              Director Global Quality, Ariad
     Location: Online                     Price : $245.00   (for one participant)

                                                                                         Amnon Eylath is Director of Quality
                                                                                         at Ariad in Cambridge,
     Overview:                                                                           Massachusetts. He is responsible for
    Ensuring GCP quality has often been approached from the                              global oversight of the QA/QC
    perspective of reviewing as many documents as possible, looking for                  aspects of Drug Substance and Drug
    errors and following up on corrections or making "notes to file." In                 Product Manufacturing, Testing,
                                                                                         Stability, Packaging and Distribution,
    order to design, implement, and maintain GCP compliance in an
                                                                                         as well as oversight of compliance
    effective manner, a Quality Systems Approach should be adopted. In
                                                                                         for Pre-Clinical (GLP) and Clinical
    the GMP and GLP domains, this approach has led to more effective                     (GCP) Studies. Amnon has over 20
    and efficient maintenance of compliance, since only by implementing                  years of experience in medical
    effective systems can quality and compliance be established,                         research, process & method
    monitored, and then maintained. Your speaker will describe the GMP                   development, device development,
    Quality System, and how, in a similar manner, a GCP Quality System                   facility/process design and
    can be utilized by ensuring the proper establishment of investigator                 validation, GxP audits and regulatory
                                                                                         compliance, CMC support,
    oversight and documentation; IRB oversight; sponsor monitoring;
                                                                                         development and deployment of
    corrective and preventive action (CAPA) execution; IP controls;
                                                                                         quality systems, as well as
    Clinical Staff and lab qualification. Your speaker will discuss each sub             disposition of Biotech and Small
    system in detail, why it exists, and how working together, they                      Molecule clinical materials for US and
    protect patient safety, rights, and welfare. Your speaker will present               international use.
    proposals for adopting this approach at clinical sites, as well as the
    role of the sponsor in establishing internal GCP quality systems, and                Amnon is currently is leading the
    ensuring compliance at the sites and CROs. The topic of auditing from                development of a technical report on
                                                                                         the application of cGMP and Quality
    a Quality Systems-Based Approach will also be discussed. Your
                                                                                         Systems for the complete
    speaker will also address why it is difficult to get clinical sites to use
                                                                                         development life-cycle of Biotech
    a "systems" approach and will give real-life examples of failures to                 Drug Substance, in collaboration with
    deploy and implement these systems properly based on recent                          industry and regulatory agency
    warning letters from FDA.                                                            representatives. He is also a core
                                                                                         member of industry Task Forces
                                                                                         developing technical reports for
     Areas Covered in the Session:                                                       application of GMPs to
                                                                                         Investigational Medicinal Product,
        l   Background for Clinical Trials and GCP (Good Clinical Practice)              Development of Specifications for
                                                                                         Early Phase drug development and
        l   The benefits of a Quality System approach
                                                                                         Risk-Based auditing. He has recently
        l   GCP Quality System
                                                                                         commented to changes in Eudralex
        l   The Importance of the sub-systems: PI Oversight and Record
                                                                                         regulations covering drug
            Keeping; IRB Oversight; Monitoring; Clinical Staff and 3rd Party             development. He has also lectured at
            Qualification; IP Handling; Pharmacovigilance/Patient Safety                 Moorpark College, UC Davis and
        l   GCP Compliance Audits                                                        Indiana University on Quality and
        l   Ranking the Severity of Observations                                         Pharmaceutical Technology subjects,
        l   Resolutions of Deviations                                                    and was instrumental in the
                                                                                         establishment of the Biotechnology
        l   References
                                                                                         certification and degree programs
                                                                                         (respectively) at Moorpark College
    Click here to register for this webinar                                              and Indiana University....more

     Who Will Benefit:
                                                                                        Suggest a Topic       More Webinars
        l   Auditors
                                                                                          Your Necessity is our Priority
        l   Study Coordinators
        l   Managers
        l   Directors
        l   Principle Investigators


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