Location: Mumbai | March 21 and 22, 2013 | 9 AM to 6 PM
Venue: The Lalit Hotel Sahar Airport, Andheri East, Mumbai
Good Laboratory Practice Regulations - Introduction and Strategies for Implementation
By Dr. Steven S Kuwahara
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Course "Good Laboratory Practice Regulations - Introduction and Strategies for Implementation" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.


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:

  • Directors
  • Managers
  • Supervisors
  • Lead workers in Product Development
  • Regulatory Affairs
  • Quality Assurance and Quality Control
  • Workers who will be participating in operations or the supervision of the development of new drugs or devices will benefit from knowing what regulations apply to non-clinical studies.
  • Workers in animal care facilities and laboratories that operate under GLP regulations should become familiar with the regulations that apply to their work.

Why you should 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.
Course Outline:
  • Day 1 - 21st March 2013
  • Day 2 - 22nd March 2013
Lecture 1: Introduction
  • Introduction and History of the GLP Regulations
  • Definitions and General Application of the Regulations
  • FDA and International GLP regulations: 21 CFR Part 58, OECD
Lecture 2: Part I of the US GLP Regulations
  • Objectives and concepts of GLP's
  • Organization and Personnel Requirements
  • Special organizational requirements
    • Management responsibilities
    • The Study Director
    • The Quality Assurance Unit
  • Facility Requirements
    • Animal care facilities
    • Operational areas and storage
  • Equipment Requirements
    • Design
    • Maintenance and calibration
Lecture 3: Part 2 of the Regulations
  • Operation of the Testing Facility
    • Standard Operating Procedures
    • Animal Care Requirements
  • Test and Control Articles
    • Handling and Characterization
    • Mixtures and Stability Studies
Lecture 4: Part 3 of the Regulations
  • Protocols for the Conduct of a Non-clinical Study
  • SOP requirements: type, formats and enforcement Contents
  • Records and Reports
    • Records keeping: format, length of time, archiving and reprocessing
    • Study result presentation
    • Storage and retention of records
  • Disqualification of Test Facilities
    • Grounds for disqualification
    • Reinstatement of a disqualified facility
Lecture 5: Modifications of the GLP for Non-animal Testing Laboratories
  • The EPA GLP for chemical and physical testing laboratories
    • Modifications to the primary GLP regulations
Lecture 6: The Animal Welfare Act
  • The main provisions of the Act.
    • Need for a Care and Use Committee
    • Composition and function of the committee
  • The National Science Foundation and their guidelines
    • The three R�s.
  • Certification and Training Groups
Lecture 7: European and other GLP Regulations
  • The European GLP
    • How different are they?
  • Other GLP and their key provisions.
Lecture 8: Types of Non-clinical Studies Subject to the GLP
GLP studies: preparation, conduct, documentation
  • Safety Studies (Toxicology)
  • Studies under the animal rule
  • Determination of the dose for the "first use in man" study.

Register Online
Group participations

Discount Slab: 5 or more participants 10% discount

To avail the above group discounts, all the participants should register by making a single payment.

Call our representative TODAY on 080 32014957 to have your seats confirmed!

Quick Contact

Toll free: 1800 425 9409
Email: Customer Support
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Account Number: 0710389004
MICR Code: 560037002
IFSC Code: CITI0000004
Branch: Citi Bank, MG Road, Bangalore - 560 001
Pricing List:

Seminar for One Delegate
Price: 18,000.     March 21 and 22, 2013 | 9 AM to 6 PM

Register now and save 2000 (Early Bird)
March 02
and March 20

Price: 20,000
January 01
and March 01

Price: 18,000

You can register for this seminar paying either by cheque or Demand Draft. To register, please make out your cheque or Demand Draft for the prescribed amount and send it to the address given below:
NetZealous Services India Pvt. Ltd.
4th Floor, A, Block,Brigade Software
Park,Banashankari 2nd stage,
Bangalore-560070. INDIA.

The Lalit Hotel Sahar Airport, Andheri East.
from 9 am to 6 pm EST at The LaLiT Mumbai


Location : Mumbai | March 21 and 22, 2013 | 9 AM to 6 PM

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 biologicals through all phases of clinical research and final product production.
Quick Contact
Toll free: 1800 425 9409
Fax: 080 26421483
Local Attractions

Juhu and Marine Drive Chowpatty Beaches

At the end of a tiring day of sightseeing, relax with the locals on the beaches of Juhu and Marine Drive, and watch the sunset. If you're feeling adventurous, you'll also be able to feast on tasty snacks offered by the multitude of food stalls and mobile food vendors.

Caves and National Park

In contrast to its millions of inhabitants and sprawling development, Mumbai surprisingly also has a national park located within its limits. It's worth a visit just to see the many ancient Buddhist caves, which have been hand carved into volcanic rock there.

Mumbai , Local Attractions

Gateway of India

Mumbai's most recognized monument, the Gateway of India, was constructed to commemorate the visit of King George V and Queen Mary to the city. It was completed in 1920 and remains as a striking symbol of the British Raj era.

Haji Ali

The imposing Haji Ali is both a mosque and tomb. It was built in 1431 by wealthy Muslim merchant and Sufi saint Pir Haji Ali Shah Bukhari, who was inspired to change the course of his life after going to Mecca. It also contains his body.

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Bangalore - 560078 Karnataka,INDIA.
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