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    US, EU and Japan GMP Requirements Practical ICH Area Differences, Healthcare Authority Inspection Focus

    Start Date : October 4, 2018
    End Date : October 5, 2018
    Time : 9:00 am to6:00 pm

    Phone : (800) 447-9407
    Email : globalcompliancepanel@gmail.com

    Location :
    Embassy Suites by Hilton Minneapolis Airport 7901 34th Ave South, Bloomington, MN 55425

    Website

    Description



    Course "US, EU and Japan GMP Requirements: Practical ICH Area Differences, Healthcare Authority Inspection Focus " has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.


    Description:


    This ICH GMP 2-Day seminar will provide your company the opportunity for comprehensive understanding of ICH GMP and the nuances and differences between the three main ICH triumvirate regions (U.S. EU and Japan). It will cover the key areas of how ICH was established, it's goals and objectives, expectations of the healthcare authorities involved and practical differences that you will experience in a GMP inspection of a facility by FDA, an EU Competent Authority or PMDA.


    The seminar will discuss in detail the:



     






    Who Will Benefit:


    This Seminar will provide invaluable assistance to all License Holder personnel in the Pharmaceutical, Biotechnology and Combination Products areas, including contract manufacturers, packagers and suppliers. Particular functional expertise receiving value from attending would be:



     


    Agenda:


    Day 1 Schedule




    Lecture 1:


    U.S., EU and Japan GMPs - Status of Harmonization and Where We're Heading





    Lecture 2:


    Where Inconsistencies Become a Problem: WHO, ICH, Countries





    Lecture 3:


    Key Chapter Reviews





    Lecture 4:


    Compliance with ICH Guidelines for GMPs





    Lecture 5:


    GMP Comparisons for APIs



     Day 2 Schedule




    Lecture 1:


    GMP Comparisons for Finished Products





    Lecture 2:


    GMP Comparisons for .......





    Lecture 3:


    Differences on Area GMP Inspections





    Lecture 4:


    Outsourcing Management......a Regional Perspective on:





    Lecture 5:


    Auditing Your Facilities for Global Considerations





    Lecture 6:


    Conclusions / Wrap-Up


    Speaker:


    Robert Russell


    President / CEO, RJR Consulting, Inc. 



    Robert J. Russell (Bob) is President / CEO of RJR Consulting, Inc. which specializes in helping clients navigate through Global Regulatory Compliance requirements for Pharmaceuticals, Medical Devices, Biologics, Combination Products and Dietary Supplement / OTC products. Prior to founding the company 17 years ago, Bob had more than 27 years of experience in CMC, Global Business development and Regulatory Affairs for two Fortune 200 firms developing innovative Pharmaceuticals and Medical Devices.


    Bob has specific expertise helping companies expand into new regions globally and meet establishment and licensing requirements, clinical trial data expectations, marketing authorization / registration preparation, meet variations / amendment filing responsibilities and license renewal filings. He has practical experience counseling Pharmaceutical and Device manufacturers through GMP, GCP, GLP requirements, CE marking / ISO certifications, Drug / Device Master File preparation, mock pre-audits and issues management with Global Healthcare Authorities. Bob is a past member of the International GMP Working Group on Standards for Industry harmonization with several colleagues from Europe. He holds a B.S. And M.S. in Chemistry.


     


     


    Location:  Minneapolis, MN Date: October 4th & 5th, 2018 and Time: 9:00 AM to 6:00 PM


    Venue:  Embassy Suites by Hilton Minneapolis Airport   7901 34th Ave South, Bloomington, MN 55425


     


    Price:


    Price: $1,295.00 (Seminar Fee for One Delegate) Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)* Register for 10 attendees Price: $7,122.00 $12,950.00 You Save: $5,828.00 (45%)*


    Register now and save $200. (Early Bird)


    Sponsorship Program benefits for seminar


    For More Information- https://www.globalcompliancepanel.com/control/sponsorship


    Contact us today!


    NetZealous LLC DBA GlobalCompliancePanel


    john.robinson@globalcompliancepanel.com


    Toll free: +1-800-447-9407


    Phone: +1-510-584-9661


     Website: http://www.globalcompliancepanel.com


     


    Registration Link - https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901468SEMINAR?seo


    Follow us on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel/


    Like us our Facebook page: https://www.facebook.com/TrainingsAtGlobalCompliancePanel/


    Follow us on Twitter: https://twitter.com/GCPanel


     


     


     




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    Registration Info

    https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901468SEMINAR?meetings4docs-oct-seo

    Contact the Organizer

    Organized by

    Organized by globalcompliancepanel

    NetZealous LLC DBA GlobalCompliancePanel ,
    161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA.

    GlobalCompliancePanel is a training source that delivers diverse, high quality regulatory & compliance trainings. These trainings are simple while being relevant and cost-effective while being convenient.

    GlobalCompliancePanel imparts knowledge of best practices across a broad range of user-friendly mediums such as webinars, seminars, conferences and tailored, individualized consulting. These help organizations and professionals implement compliance programs that meet regulatory demands and put business processes in place.

    GlobalCompliancePanel focuses primarily on providing extensive and quality training in these core areas and anything related to them:

    • Risk Management
    • Regulatory Compliances
    • Corporate Governance
    • Quality Management
    Tel: 800-447-9407
    Email: globalcompliancepanel@gmail.com
    Website: https://www.globalcompliancepanel.com/


    Event Categories: Emergency Medicine.




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