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 the regulations require and HOW to implement validation of laboratory instruments in your own work environment.
Who is this course intended for?
You are a laboratory technician, analyst or lead analyst with a secondary or undergraduate 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 about validation.
During the course you will be introduced to the following topics:
GMP / GLP principles and requirements, overview.
Calibration, qualification and validation
LSV (Lab System Validation): The life cycle of an instrument/software, validation documentation, User Requirements Specifications (URS)
Validation plan setup and execution: Qualification protocols; Execution of tests and documentation GDP (Good Documentation Practice)
Maintenance: Maintaining validated situation, repairs, change of control and revalidation; Retirement (decommissioning, taking out of active GxP use), periodic testing
Computer and 21CFR Part 11
09:30am – 11:00am Introduction, definitions and categories (The “what” part)
11:00h – 11:15h coffee break
11:15h – 12:15h Regulatory requirements and business benefits (The “why” part)
12:15h – 13:15h lunch
13:15h – 13:30h Roles and responsiblities (The “who” part)
13:30u – 14:30u High level documentation – documentation workshop
14:30u – 15:00u Life cycle approach – selection new systems (The “how” part)
15:00u – 15:15u coffee break
15:15h – 16:00h Life cycle approach – workshop Validation Plan
16:00h – 17:00h Life cycle approach – user requirements – risk analysis
09:00h – 9:15h summary of day 1
09:15h – 10:15h Life cycle approach – workshop user requirements and risk analysis
10:15h – 10:30h coffee break
10:30u – 11:00u Life cycle approach – DQ, IQ, OQ, PQ
11:30h – 12:15h Life cycle approach – validation documentation – deviations
12:15h – 13:15h lunch
13:15u – 14:30u Life cycle approach – workshop test description
14:30u – 14:45u coffee break
14:45h – 15:00h Good documentation practices (GDP)
15:00h – 15:45h Data integrity (Part 11)
15:45h – 16:00h evaluation
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 students. During a number of workshops the theory will be applied in practical situations. The outcomes of the workshops are again discussed in detail.
Upon completion of the course, you will have a clear understanding of the various validation models and will be able to choose the one most appropriate for your work environment. You will learn to set up and execute a validation plan, with the appropriate documentation for each phase.
After successful completion of the course, you will receive a certificate of participation.
The course lasts for two consecutive days: May 23 and 24, 2019.
The investment for the course is as follows:
Course fee € 1,290 (excluding 21% VAT).
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