Seminar on “Good Laboratory Practice Regulations” at Mumbai

All rights are reserved © GlobalCompliancePanel.

2-day In-person Seminar on “Good Laboratory

Practice Regulations - Introduction and Strategies

for Implementation” at Mumbai

INDIA SEMINAR AT MUMBAI

DATE

March 21 and 22, 2013

AT

The Lalit Hotel Sahar Airport, Andheri East.

from 9 am to 6 pm EST at The Lalit Mumbai


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.


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.

OVERVIEW

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.

Lecture 1: Introduction

Lecture 2: Part I of the US GLP Regulations

Lecture 3: Part 2 of the Regulations

Lecture 4: Part 3 of the Regulations


Course Outline

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

Lecture 6: The Animal Welfare Act

Lecture 7: European and other GLP Regulations

Lecture 8: Types of Non-clinical Studies Subject to the GLP

Day 1 - 21st March 2013 Day 2 – 22nd March 2013


Directors Managers Supervisors

Lead workers

in Product

Development

Regulatory

Affairs

Quality

Assurance

and Quality

Control

Who Will Benefit

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.

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

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 biological through all phases of clinical research and final product production.

Dr . Steven S Kuwahara, President of GlobalCompliancePanel Consulting


Our Previous Seminar Photos


Register Online

Register

now and

save 2000.

(Early Bird)

Between

January 1

and

February 15

Price:

18,000

Between

February 16

and

March 17

Price:

20,000



ClientsGlobalCompliancePanel Partial Client List


Contact Information:


Event Coordinator

Toll free: 1800 447 9407

Fax: 302 288 6884

Email:

[email protected]

Net Zealous

GlobalCompliancePanel

NetZealous Services India Pvt. Ltd.

4th Floor, 'A' Block,Brigade Software

Park,Banashankari 2nd stage,

Bangalore-560070, INDIA


Seminar on “Good Laboratory Practice Regulations” at Mumbai

Documents

Transcript of Seminar on “Good Laboratory Practice Regulations” at Mumbai