Docstoc

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

Document Sample
2-day In-person Seminar on “Good Laboratory Practice Regulations - Introduction and Strategies for Implementation” at Mumbai Powered By Docstoc
					                INDIA SEMINAR AT MUMBAI



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

                             The Lalit Hotel Sahar Airport, Andheri East.
March 21 and 22, 2013
                            from 9 am to 6 pm EST at The Lalit Mumbai




                                   All rights are reserved © GlobalCompliancePanel.
Kindly find below the Benefits of attending the GLP Seminar

      1. Two days of seminar by the renowned speaker, Dr. Steven S.
         Kuwahara
      2. Complete training material of the workshop
      3. Two networking tea breaks, where you can interact with your
         peers in the Industry
      4. Post seminar e-mail assistance directly from the speaker
      5. Participation Certificate
      6. Q & A sessions after each lecture, which gives you an
         opportunity to explore and evaluate the challenges and various
         issues not only with the speaker but also with 25 to 30
         different companies’ delegates
      7. Buffet lunch at the 5-star hotel.

                     All rights are reserved © GlobalCompliancePanel.
                             OVERVIEW
      Course "Good
   Laboratory Practice      This course will present the regulations and guidelines that
       Regulations -        apply to the safety testing of medical products and also
     Introduction and       discuss the rules as they apply to testing laboratories that
       Strategies for       study samples derived from test animals or test subjects in
  Implementation" has       clinical studies. The purpose of the course will be to instruct
  been pre-approved by      laboratory personnel in the material that they must know or
RAPS as eligible for up
                            prepare to pass an FDA inspection. The course will also
 to 12 credits towards a
    participant's RAC       discuss the types of studies that come under the GLP
recertification upon full   regulations.
        completion.



                                                                All rights are reserved © GlobalCompliancePanel.
                               Course Outline
   Day 1 - 21st March 2013                                              Day 2 – 22nd March 2013

Lecture 1: Introduction                                        Lecture 5: Modifications of the GLP for Non-
                                                               animal Testing Laboratories

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


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

                                                               Lecture 8: Types of Non-clinical Studies Subject to the GLP
Lecture 4: Part 3 of the Regulations




                                       All rights are reserved © GlobalCompliancePanel.
                 Who Will Benefit


                                                                                  Quality
                                              Lead workers
                                                                   Regulatory    Assurance
Directors   Managers       Supervisors         in Product
                                                                     Affairs    and Quality
                                              Development
                                                                                  Control




                       All rights are reserved © GlobalCompliancePanel.
           Why Should you Attend
Any pharmaceutical worker who performs, supervises or reviews non-clinical studies
related to product safety should attend this course. This includes workers who perform
studies on samples derived from animals or clinical subjects and anyone performing,
supervising or reviewing non-clinical safety studies on any type of product that is
regulated by the U.S. Food and Drug Administration. Regulatory Affairs workers who
prepare submissions for regulatory agencies also need to be aware of these
regulations and their requirements, as they are needed for regulatory submissions.




                     All rights are reserved © GlobalCompliancePanel.
                                      What you get:
1.Learning Objectives
2. Participation certificates
3. Interactive sessions with the US expert
4. Post event email assistance to your queries.
5. Special price on future purchase of web based trainings.
6. Special price on future consulting or expertise services.
7. Special price on future seminars by GlobalCompliancePanel.
8. Seminar Kit – includes presentation handout, ID card, brochure,
trainings catalog, notepad and pen.
9. Networking with industry's top notch professionals
                                                         www.globalcompliancepanel.com



                                                              All rights are reserved © GlobalCompliancePanel.
                           ABOUT SPEAKER:

                                       Dr. Steven S. Kuwahara Ph.D. is the founder and
                                       Principal of GXP Biotechnology LLC, a consulting firm
                                       that works in the areas covered by the GLP and GMP of
                                       drugs, biologics, and nutraceuticals.
                                       Steve has over 30 years of experience in supervising
                                       quality control laboratories, including an animal testing
                                       facility, and in performing GLP and GMP audits of
                                       internal and external testing laboratories.
                                       Steve has participated in the development of drugs and
Dr . Steven S Kuwahara, President of   biological through all phases of clinical research and final
GlobalCompliancePanel Consulting       product production.




                                                          All rights are reserved © GlobalCompliancePanel.
Our Previous Seminar Photos




                         All rights are reserved © GlobalCompliancePanel.
                  Register Online

  Register      Between                      Between
 now and        January 1    Price:         February 16               Price:
save 2000.         and       18,000              and                  20,000
(Early Bird)   February 15                   March 17




                                      www.globalcompliancepanel.com



                                         All rights are reserved © GlobalCompliancePanel.
             Clients
GlobalCompliancePanel Partial Client List




                                            All rights are reserved © GlobalCompliancePanel.
Contact Information:
    Event Coordinator
    Toll free: 1800 447 9407
    Fax: 302 288 6884
    Email:
    support@globalcompliancepanel.com
    Net Zealous
    GlobalCompliancePanel
    NetZealous Services India Pvt. Ltd.
    4th Floor, 'A' Block,Brigade Software
    Park,Banashankari 2nd stage,
    Bangalore-560070, INDIA
  www.globalcompliancepanel.com

                       All rights are reserved © GlobalCompliancePanel.

				
DOCUMENT INFO
Categories:
Stats:
views:5
posted:1/25/2013
language:
pages:13
Description: 2-day In-person Seminar on “Good Laboratory Practice Regulations - Introduction and Strategies for Implementation” at Mumbai