It is essential for pharmaceutical companies to be able to show that the process will consistently lead to expected results. This is called validation. Without properly documented processes a company cannot meet GMP and regulatory requirements and may consequently suffer substantial revenue loss.
Background: One of our clients, who is a major manufacturer of vaccines with several production sites around the world, typically has 10 to 30 personnel involved in process validation at each site. As some validation activities are cyclical, there are peaks of validation activity during the year and additional personnel are sometimes seconded to the process areas at different times.
The Challenge: Given the varying numbers of staff and temporary workers, the challenge for our client was to ensure that all validation activities were performed consistently at all times across all manufacturing sites. In order to meet this challenge, our client decided to provide specialized validation training to all personnel likely to be involved in validating the process in all sites worldwide. The selected method to achieve this was to build e-learning modules reflecting the client’s “best practices” in validation. The services of Skillpad were engaged to build the modules.
The Skillpad Approach: As with all of our custom projects, we put together a project team comprising our own experienced biotech subject matter experts (SME) and skilled multimedia developers. The team worked closely with the most experienced members of our client’s personnel to determine “best practice” for process validation. This knowledge was captured in custom e-learning modules designed to be hosted on our client’s Learning Management System (LMS) thereby facilitating rapid and efficient dissemination throughout the facility.
- Consistency in the performance of validation work.
- Reduced risk of non-compliance thanks to consistent processes.
- Effective refresher training for existing staff using the modules.
- Reliable validation work forecasting.
- Seconded employees were brought up-to-speed more quickly.
- Modules were designed to permit ease of updating when incorporating new “best practices” at low cost.
To find out how Skillpad custom modules can help you, visit our products section.