2-day In-person Seminar on “Good Laboratory Practice Regulations - Introduction and Strategies for Implementation” at Mumbai by globalcompliancepane

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     2-day In-person Seminar on

     Good Laboratory Practice
     Regulations - Introduction and
     Strategies for Implementation
 
                                     By - Dr. Steven S
      Duration: 2 Days
                                            Kuwahara
                                                           

      Price: INR 18,000.00 (for 1 attendee)
      ***We do Provide In-House Training for the           
      Same Subject (Minimum 25 Participants)
                                                                            Register Now

       Past Seminars




     Course Outline: Day 1                                    Course Outline: Day 2

     Lecture 1: Introduction                                  Lecture 5: Modifications of the GLP for Non-animal
                                                              Testing Laboratories
        l   Introduction and History of the GLP
            Regulations                                          l   The EPA GLP for chemical and physical testing
        l   Definitions and General Application of the               laboratories
            Regulations                                                  ¡ Modifications to the primary GLP
        l   FDA and International GLP regulations: 21 CFR                  regulations
            Part 58, OECD


     Lecture 2: Part I of the US GLP Regulations              Lecture 6: The Animal Welfare Act


        l   Objectives and concepts of GLP's                     l   The main provisions of the Act.
        l   Organization and Personnel Requirements                     ¡ Need for a Care and Use Committee
        l   Special organizational requirements                         ¡ Composition and function of the
               ¡ Management responsibilities                              committee
               ¡    The Study Director                           l   The National Science Foundation and their
               ¡    The Quality Assurance Unit                       guidelines
        l   Facility Requirements                                        ¡ The three R's.
                ¡ Animal care facilities                         l   Certification and Training Groups
               ¡ Operational areas and storage
        l   Equipment Requirements
               ¡ Design

               ¡   Maintenance and calibration


     Lecture 3: Part 2 of the Regulations                     Lecture 7: European and other GLP Regulations


        l   Operation of the Testing Facility                    l   The European GLP
               ¡  Standard Operating Procedures                         ¡ How different are they?
                ¡ Animal Care Requirements                       l   Other GLP and their key provisions.
        l   Test and Control Articles
                ¡ Handling and Characterization

               ¡   Mixtures and Stability Studies


     Lecture 4: Part 3 of the Regulations                     Lecture 8: Types of Non-clinical Studies Subject to
                                                              the GLP
        l   Protocols for the Conduct of a Non-clinical       GLP studies: preparation, conduct, documentation
            Study
        l   SOP requirements: type, formats and                  l   Safety Studies (Toxicology)
            enforcement Contents                                 l   Studies under the animal rule
        l   Records and Reports                                  l   Determination of the dose for the "first use in
               ¡ Records keeping: format, length of time,            man" study.
                  archiving and reprocessing
               ¡  Study result presentation
               ¡  Storage and retention of records
        l   Disqualification of Test Facilities
            ¡   Grounds for disqualification
            ¡   Reinstatement of a disqualified facility



   Overview:
This course will present the regulations and guidelines that apply to the safety testing of medical products and
also discuss the rules as they apply to testing laboratories that study samples derived from test animals or
test subjects in clinical studies. The purpose of the course will be to instruct laboratory personnel in the
material that they must know or prepare to pass an FDA inspection. The course will also discuss the types of
studies that come under the GLP regulations.


   Who Will Benefit:                                                               Instructor Profile:
                                                                                            Dr. Steven S Kuwahara

    l   Directors                                                                          Founder & Principal, GXP

    l   Managers                                                                              Biotechnology, LLC

    l   Supervisors                                                                Steven S. Kuwahara, Ph.D. is
    l   Lead workers in Product Development                                        the founder and Principal of GXP
    l   Regulatory Affairs                                                         BioTechnology LLC, a consulting
    l   Quality Assurance and Quality Control                                      firm that works in the areas
                                                                                   covered by the GLP and GMP of

                    Download Registration Form                                     drugs, biologics, and
                                                                                   nutraceuticals. ...more


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www.globalcompliancepanel.in                                                   www.globalcompliancepanel.com
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