Tips on Solving Common Training Management Challenges for Life Science Companies
A Warning Letter sent by the FDA in February to Medical Concepts Development, a Minnesota medical device company, listed eight CGMP violations. Two of the infractions were related to training management: failure to document employee training and failure to establish procedures for identifying training needs.
Why is training important to life science companies? The FDA states it clearly in the Quality System Regulation (QSR) Manual, which says: ?Quality is the responsibility of every employee ? any employee can generate a quality problem through ignorance of their job requirements or negligence.?
It is imperative for life science employees to have the proper education and training for their jobs. Moreover, the FDA expects employers to provide continuous personnel training to make sure employees can effectively perform their jobs. Ongoing training is what makes training management critical; it is the area where many life science companies stumble. Here are five common challenges faced by life science companies and some possible solutions.
1. Overwhelming Volume of Training Tasks. Let's take the hypothetical case of a small pharmaceutical manufacturer with 200 employees. Perhaps 150 of these employees are directly involved in manufacturing and covered by the FDA's CGMP regulations. If each employee is required to take three training courses a year, we're talking 450 training tasks, right off the bat. The fact is, most life science employees need more than three training courses annually. Corrective actions, quality audit findings, and changes (in processes, SOPs, policies, etc.) all potentially require training. If your company relies on a paper-based or partially electronic system, the paperwork for thousands of training tasks can be overwhelming, not to mention the job of tracking and verifying each task.
Training Management Solution: Automating your paper-based training system is the best solution for this problem. A software solution scales to handle more training tasks than your training coordinator can handle manually. An electronic training management system will automate assignment, tracking, and verification of training tasks. A Web-based system will give access to all authorized users from virtually anywhere. Choose a robust system that allows you to distribute and grade online training exams automatically.
2. Poor Communication. Training management requires two-way communication. The coordinator needs to inform all trainees about their tasks. Trainees need to communicate back upon completion of training. And in between, there's a need to remind people, or escalate tasks. Under a manual system, communication entails uncoordinated e-mail messages, phone calls, and face-to-face reminder, all of which are difficult to track.
Training Management Solution: With an automated system, your users will be automatically notified when they have new training tasks. Trainees will then sign off after completing training, and the training coordinator or the verifier will immediately be notified when a training task has been completed. There won't be any need to send uncoordinated reminders via e-mail or phone because the system will do the follow up and escalation based on real-time data.
3. Trainees Don't Feel Accountable. A manual system doesn't promote a sense of accountability. The person who has the training paperwork ? usually the training coordinator ? is deemed responsible for the training program. In fact, trainees are equally responsible. But because a manual system offers them no access to their training records and no capability to easily communicate and interact during the tracking process, they are unlikely to feel accountable for the training's overall success.
Training Management Solution : An automated system will require participation from trainees, so it will increase the individual's sense of accountability. Each trainee will automatically receive his/her immediate training tasks, making it easier to complete the tasks on time. A good system would allow each trainee to view upcoming and completed training records, significantly improving both buy-in and accountability.
4. Training not Integrated with Document Control and Other Processes. In the FDA environment, the concept of quality is made tangible by repeatable processes that are specified, tested, and documented. Employees must be trained on processes and their corresponding documentation. Any significant change to processes and documents is likely to call for re-training. So, a training system that is not integrated with document control, change control, corrective/preventive action (CAPA), and other processes is inherently inefficient and possibly ineffective. It will require more effort and constant vigilance on the part of employees.
Training Management Solution: An effective solution will synchronize changes (in documents, documented processes, etc.) and corresponding courses. Any document change because of a CAPA, for example, will trigger new training tasks. If there's any change in a document linked to a required course because of a revised SOP or policy, all affected trainees will immediately receive new training tasks. Select a Web-based system to give access to all authorized employees regardless of location.
5. Not Prepared for Audits and Inspections. For companies using a paper-based training system, preparing for an internal audit or an FDA inspection requires a major effort in generating, tracking, and gathering training documentation. The visibility of the training program and related documentation becomes especially critical when there are deviations and nonconformances. FDA inspectors generally look at the effectiveness of the training program when they observe quality problems. The assumption is that quality issues are likely to be caused by inadequate training.Training Management Solution: An electronic system will serve as your centralized repository for all training documentation, making search and retrieval easy during internal audit or FDA inspection. A system that incorporates online testing and grading will allow you to readily show proof of personnel competency during inspection. Select a software solution that provides continuous training gap analysis between required and completed training for all trainees. Make sure the solution will be able to automatically assign training tasks based on the gap analysis.
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