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GMP Compliance for Dietary Supplements


The U.S. Food and Drug Administration issued the final rule establishing regulations to require current good manufacturing practices (CGMPs) for dietary supplements.

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    Live Webinar          on
      GMP Compliance for Dietary Supplements

     Course "GMP Compliance for Dietary Supplements" has been
     pre-approved by RAPS as eligible for up to 1.00 credits towards
     a participant's RAC recertification upon full completion.
                                                                                                  Register Now                           

    Date & Time:
                                                                                            Instructor Profile:
     Wednesday, June 13, 2012            10:00 AM PDT | 01:00 PM EDT

     Duration: 60 Minutes                Instructor: Dr. Efrem H. Zaret                                Dr. Efrem H. Zaret
                                                                                                   President, EZ Associates Inc.
     Location: Online                    Price : $245.00   (for one participant)

                                                                                            Dr. Efrem Zaret, President of EZ
                                                                                            Associates Inc., is actively engaged
                                                                                            in consulting assignments involved
    The U.S. Food and Drug Administration issued the final rule                             with the Chemistry, Manufacturing,
    establishing regulations to require current good manufacturing                          Control, and Quality of new and
    practices (CGMPs) for dietary supplements.                                              existing drug products, dietary
                                                                                            supplements and active
                                                                                            pharmaceutical ingredients and with
    The current good manufacturing practices (CGMPs) final rule will
                                                                                            the preparation and logistics of
    require that proper controls are in place for dietary supplements so
                                                                                            clinical supplies. He assists clients in
    that they are processed in a consistent manner, and meet quality                        the identification and control of
    standards. The CGMPs apply to all domestic and foreign companies                        contract service organizations, drug
    that manufacture, package, label or hold dietary supplements,                           evaluation and testing, with the
    including those involved with the activities of testing, quality control,               preparation and implementation of
    packaging and labeling, and distributing them in the U.S. The rule                      quality systems and with
    establishes CGMPs for industry-wide use that are necessary to                           submissions to the FDA. He also
                                                                                            does training on GMP principles and
    require that dietary supplements are manufactured consistently as
                                                                                            related topics.
    to identity, purity, strength, and composition. The requirements
    include provisions related to: the design and construction of physical                  Dr. Zaret has industrial experience
    plants that facilitate maintenance, cleaning, proper manufacturing                      in the development, manufacturing,
    operations, quality control procedures, testing final product or                        packaging and evaluation of drugs,
    incoming and inprocess materials, handling consumer complaints,                         foods, nutritionals, and other
    and maintaining records.                                                                regulated products both in the United
                                                                                            States and in Europe. Dr. Zaret
                                                                                            obtained his B.S. in Chemistry from
     Why should you attend:                                                                 the Illinois Institute of Technology
    The regulations require that you understand the requirements and                        and his M.S. and Ph.D. degrees in
                                                                                            Organic Chemistry from the
    establish a Quality System designed to meet them. This presentation
                                                                                            University of Wisconsin-Milwaukee.
    will review the requirements and the rationale for them.

     Areas Covered in the Session:
                                                                                           Suggest a Topic         More Webinars
        l   History of the regulations and their current status
                                                                                             Your Necessity is our Priority
        l   Review of the key points of the regulations
        l   Discussion of methods that can be used to comply with the
        l   Documentation that is required for compliance
        l   The role of the Quality organization
        l   What to expect during an FDA inspection                                                             
        l   How to respond to an FDA inspection
        l   Raw material control and incoming inspection
        l   Cleaning and Maintenance

    Click here to register for this webinar

     Who Will Benefit:

        l   Senior Management
        l   Quality Control Management and personnel
        l   Manufacturing management and supervisors
        l   Warehouse Management and supervisors
        l   Shipping and Distribution Management and supervisors

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,

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