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Pack of TEN: Best Selling Pharma Webinars by GlobalCompliancePanel

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    Webinar Pack
    Pack of TEN: Best Selling Pharma Webinars by GlobalCompliancePanel
    Actual Price:         $2950.00

    Your Price:           $1095.00
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    GMP Expectations for Products Used in Early Phase
    IND Studies
    FDA issued a guidance document covering GMP requirements for
    Phase 1 products. These guidelines remove some of the problems
                                                                                Instructors:
    that are encountered with early phase products and are in addition
    to those that cover the CMC sections for IND submissions at Phase
                                                                                          Steven S Kuwahara
    1.
                                                                                         Founder & Principal, GXP
                                                                                           Biotechnology, LLC
    GMP for Phase 1 Products
    This presentation will cover the contents of the guidance that was          Steven S. Kuwahara, Ph.D. is the
    given.                                                                      founder and Principal of GXP
                                                                                BioTechnology LLC, a consulting firm
    FDA has issued as rule that relieves Phase 1 products from                  that works in the areas covered by
    complying with the GMP given in 21 CFR 211.                                 the GLP and GMP of drugs, biologics,
                                                                                and nutraceuticals. ..more

    Transfer of Analytical Methods and Procedures: FDA
                                                                                           Dr. Ludwig Huber
    Requirements and Strategies and Tools for
                                                                                        Chief Advisor - Global FDA
    Implementation
                                                                                           compliance, Agilent
    When validated methods are transferred between laboratories and
                                                                                               Technologies
    sites, their validated state should be maintained to ensure the
    same reliable results in the receiving laboratory.                          Ludwig Huber, Ph.D., is Director of
                                                                                Labcompliance and Chief Advisor for
    Understanding and Implementing USP <1058>                                   global FDA compliance at Agilent
    Analytical Instrument Qualification                                         Technologies. ..more
    Analytical instruments should be qualified to demonstrate suitability
    for the intended use. Despite the fact that instrument qualification                   Kerry Paul Potter
    is nothing new and companies spend a lot of time, it is a frequently                   President, Summit
                                                                                            Consulting, Inc.
    cited deviation in FDA inspectional observations and warning
    letters.
                                                                                Kerry gained his pharmaceutical
                                                                                manufacturing experience during his
    Understanding the New USP Chapter 1224 for Transfer                         28-year career with Merck. His
    of Analytical Methods                                                       career spanned the areas of Quality
    When validated methods are transferred between laboratories and             Operations, Audits & Inspections,
    sites, their validated state should be maintained to ensure the             Laboratory, Human Resources, and
    same reliable results in the receiving laboratory.                          Learning & Development. ..more
                                                                             
    Calibration and Qualification in Analytical Laboratories
    Laboratory equipment should be calibrated and/or qualified to
                                                                                Your Necessity is our Priority
    demonstrate suitability for the intended use.

    Laboratory systems including equipment are amongst key targets
    of FDA inspections.


    Good Documentation Practices for GMP Operations
    Whether you work in production or in a laboratory or if you conduct
    investigations or finalize product release, sound data and
    information is essential to success and compliance. .


    Learning from Recent FDA Warning Letters Related to
    Computer Validation and Part 11 - Prepare Yourself for
    the upcoming FDA Part 11 Inspections
    On July 8, 2010, the FDA announced to soon conduct a series of
    inspections related to 21 CFR Part 11.

    FDA made it very clear that the focus of the inspections will on most
    critical issues the industry had with Part 11 in the past.


    Good Laboratory Practice Regulations - Introduction
    and Strategies for Implementation
    Complying with GLP regulations can increase the cost of a
    laboratory up to 30%. Companies or employees either don't know
    exactly what GLP really means, what procedures are required and
    how to implement GLP regulations.


    Understanding Analytical Test Results: Comparing Two
    Sets of Data
    The class will cover the understanding the properties of single test
results and how they may be compared.

There are many problems that arise from a misunderstanding of the
properties of single data sets and the problems are compounded
when data sets are compared.



Click here to buy the webinar pack
It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely
benefit from this program.

For more information, please contact the event coordinator. We look forward to seeing you at the webinar.

Best regards,
Event-coordinator
GlobalCompliancePanel



About GlobalCompliancePanel
GlobalCompliancePanel is an online knowledge fulfillment community portal & it has put together a new model for online
compliance training by creating a single window of learning opportunities for compliance professionals & providing a
forum for expert speakers/panelists to render their services through simplified online training delivery mechanisms. Our
commitment is give compliance regulatory training, showcasing of best industry practices & quality enrichment training
sessions in a most cost effective manner. Compliance professionals can benefit from a wide range of training sessions,
giving a diverse choice of events & all sessions being either Live or recorded stream or in the form of audio CDs.
GlobalCompliancePanel portal ensures a secure & cost effective online environment and also support your E-learning
and development on/through our website. Keep track of all webinars arranged for your industry through notifications &
event calendars being mailed to your inbox. GlobalCompliancePanel opens new doors of learning opportunities for
professionals.


GlobalCompliancePanel
www.globalcompliancepanel.com
1000 N West Street Suite,
1200 Wilmington DE 19801

Phone: 800-447-9407 or
Fax your PO to: 302-288-6884


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DOCUMENT INFO
Description: FDA issued a guidance document covering GMP requirements for Phase 1 products. These guidelines remove some of the problems that are encountered with early phase products and are in addition to those that cover the CMC sections for IND submissions at Phase 1