This training is for PLA 3.0 users with the desire to bring their skills to the next level. It is the fastest and easiest way to understand the advanced features of PLA 3.0.
We offer the PLA 3.0 Super User Training as a 2-day training event for a small group. The small-group setting allows us to customize the training agenda to the individual requirements of the participants and to answer your specific questions.
The training is a mixture of presentation, exercises and discussion.
The training concept is modular and the agenda depends in some parts on the needs of the attendees.
- Introduction to PLA 3.0
General introduction into the capabilities of PLA 3.0 and the basic concepts
- What has changed from PLA 2.x?
If users of PLA 2.x are present in the training, the major differences between versions will be explained
- Basic Operations
Day-to-day operations within the PLA system from an operator and administrator perspective
- Capabilities (Document Types)
Analytical capabilties of the system in terms of Quantitative Response Assays, Dichotomous Assays (optional), Equivalence Margin Development for the support of the USP <1032>, Control Charting, Combination Calculation for the calculation of reportable values and Basic Bioassay Protocol. Measurement Documentation capabilities of the system
- Advanced Operations
Operations and capabilities beyond the day-to-day operations, e.g. Raw Data Traceability features, Audit Trail
- Workflow Support
Template System and Basic Bioassay Protocol to support integrated runs for reportable values
- Template Generation
- Setting up complex assays
Definition and protection of templates, efficient template generation
- Statistical Aspects
Statistical capabilities of Quantitative Response Assays and Combination Calculations within PLA 3.0
- IT Administration
Optional: How to setup and manage PLA 3.0. Active Directory Integration, User and Security Management
Configuration Item List, 21 CFR Part 11 Compliance, Audit Trail, Installation Qualification, Operational Qualification, Performance Qualification
During the training, two protocols (a simple and a sophisticated protocol) will be implemented for use by operators.
When you’ve been working with PLA 3.0 for any length of time, you will have noticed that it is a very powerful software for biological assays. But people often overlook that the software can do way more than just calculate biological assays. It is also capable of controlling more complex scenarios including automated calculation of reportable values from a number of assay runs.
And beyond this, it is capable of applying tests on these reportable values as well as handling retest scenarios - even in multi-product assays. This can be done by using the Basic Bioassay Protocol. If you haven’t heard of these features up to now, then you should definitely consider taking a Super User Training.
Each participant will work with his/her own laptop computer and receive a PLA 3.0 database with exercises. We are going to provide a checklist regarding installation requirements in advance.