Research Quality Assurance
for Good Laboratory Practice (GLP)
Course Description
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
CERTIFICATION
Successful participants will receive Peganix’s Certificate of Completion.
All attendees to a Peganix accredited course receive a Certificate of Accreditation acknowledging their training and their journey to New Skills, New Thinking. Independent research has verified that this recognition is highly valued by your employees.
In-person / On Location
Our team and, your health and safety are our top priority. We have limited our registration numbers to 25 people per meeting to provide enough distance per person, hand sanitizers with face masks will be provided for all attending delegates and a temperature scanner will be available at the venue.
Our team and the venue are fully prepared to assist you.
Live Online / Virtual
Registered delegates can log in and join the live meeting. The online platform will not limit your participation, as you can engage on the platform via live chat text, audio, or video. All live meetings will be recorded and made available to all participants.
At any point, you’re not feeling too well to attend the in-person meeting you can simply log in at home and join live online.
- 2, 3 & 4 June 2021
- Johannesburg, South Africa
- In-Person
- Virtual
-
ZAR5, 999.00 (Virtual)
ZAR10, 999.00 (In-Person)
Contact Us
- registration@peganix.com
- +2711 041 0181
- +2768 053 6221
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