Validation of laboratory instruments (LSV) 2020

Why the “Validation of laboratory instruments (LSV)” course?

Many laboratories work in a regulated environment and thus come into contact with GMP (Good Manufacturing Practice) and GLP (Good Laboratory Practice) regulations. These regulations hold the user responsible for the validation status of the laboratory instrument. In this course, you will learn what maintaining validation status in a laboratory environment entails; WHAT do the regulations require and HOW do you implement validation of laboratory instruments in your own working environment.

Who is this course for?

You are a laboratory employee, analyst or lead analyst with an mbo or bachelor background. As part of your work, you perform laboratory instrument validations. The course is also suitable for employees, from validation and QA departments who want to expand their knowledge on validation.

The programme
The following topics will be covered over 2 days.

Day 1:

• Introduction, definitions and categories
• Regulatory requirements and business benefits
• Roles and responsibilities
• Life cycle approach; Selection of new systems
• Life cycle approach; Validation Plan
• Life cycle approach; User requirements (URS) and risk analysis

Day 2

• Life cycle approach; User requirements and risk analysis workshop
• Life cycle approach; DQ, IQ, OQ, PQ
• Life cycle approach; Validation documentation, deviations
• Life cycle approach; Workshop test description
• Good documentation practices (GDP)
• Data integrity

Methodology
While covering theory, you will hear a lot about common bottlenecks when implementing and working in a regulated environment. You will exchange experiences with teacher and fellow course participants. During a number of workshops, the theory is applied in practical situations. The outcomes of the workshops are again discussed in detail.

The result
On completion of the course, you will have a clear picture of the various validation models and will be able to choose which model is most suitable for your working environment. You will learn to set up and execute a validation plan, with appropriate documentation for each phase.

The diploma
After successful completion of the course, you will receive a certificate of attendance.

Time slot
The course lasts for two consecutive days: 23 and 24 November.

Financial investment
The investment for the course is as follows:
Course fee €1,290 (excluding 21% VAT)

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