WHY CHOOSE THIS TRAINING COURSE?


 |This course offers the ideal external training opportunity for those starting out as Quality Assurance auditors or working
under Good Laboratory Practice regulation for the first time.


The main intent of this course is to review the requirements imposed by Good Laboratory Practices (GLP) regulations
for facilities engaged in toxicology and product safety testing, primarily in animals and biological test systems. The
res possibilities and functions of management including the Study Director, Principal Investigator and the Quality 
Assurance Unit (QAU) will be covered. Various procedures for meeting the requirements of the regulations will be
 presented.


Emphasis will be placed on the practical implementation of GLP and discussion including problems that the participants
bring to the course.

This course is structured to encourage delegates to:


• Discuss and develop ideas

• Solve specific problems

• Examine particular aspects of GLP

Benefits Include:


• Sound regulatory basis for quality assurance activities

• Clear understanding of the role of Quality Assurance, Management, and Study Director under the Good Laboratory Practice
 principles

• Improved inspections and audits

• Improved Good Laboratory Practice compliance for your facility

• An insight into government GLP monitoring activities

Who should attend?

This course is intended for all management within the industry, government, academia, and/or contract biological testing facilities especially.

• Scientists Regulatory/Compliance Personnel

• Quality Assurance Staff

• Those newly assigned GLP responsibilities

• More experienced personnel needing to update their knowledge

DAY ONE

08:55 Registration
09:00 Welcome and Introduction

09:15 Good Laboratory Practice Standards and Regulations
An insight into the background and history of Good
Laboratory Practice:

09:45 Principles of Quality Assurance (1)
The role and responsibilities of QA:

10:30 Break Time

10:45 Principles of Quality Assurance (2)
The role and responsibilities of QA:

11:30 Study Plans
GLP requirements and QA involvement:

12:05 Standard Operating Procedures
GLP requirements and QA involvement:

13:00 Lunch Break

14:00 Inspections
Attitudes, techniques, and attributes:

14:40 Workshop 1– Facility and Process Inspections
An exercise in inspection planning and preparation for inspections:

15:15 Break Time

15:30 Workshop 1– Continued
16:15 Workshop 1–Feedback

16:30 Panel Session 
An opportunity for delegates to put questions to the
panel of speakers:

17:15 Close Of Day

DAY TWO

09:00 Workshop 2 – A Mock Audit

10:45 Break Time

11:00 Workshop 2 – Feedback
11:30 Auditing the Study Report
Techniques and methods for the QA audit of the study report:

12:00 The Management of Raw Data, Record Keeping
and Training Records (1)

• The impact of GLP on data and records management
• The use of computers in a GLP environment

12:45 Lunch Break

13:30 The Management of Raw Data, Record Keeping
and Training Records (2)

14:15 Workshop 3 – Amendments to Study Plan and
Deviations from the Plan

•  What are they?
• What is the difference between them?
• How are they controlled?

15:15 Break Time

15:30 Workshop 3 – Feedback
Regulatory Compliance Government monitoring for compliance with Good
Laboratory Practice:

16:15 Panel Session
An opportunity for delegates to put questions to the panel of speakers:

16:45 Close Of Course