Life science organizations including pharmaceutical, medical devices, and biopharma manufacturers typically offer comprehensive training programs. Besides having to meet stringent regulatory training requirements, operationally, these types of organizations have many complex processes. Even if these organizations strive to automate these complex processes, nothing is foolproof and, at the end of the day, nothing beats a well-trained workforce. In fact, employee training is the ultimate foundation of good manufacturing practices (GMP). Alternatively, poorly trained employees pose a threat to productivity and even product quality, which can have costly or devastating outcomes. Investing in employee training is really crucial to business success in life science manufacturing.
FDA Training Requirements
The FDA requires that “each person engaged in the manufacture, processing, packing, or holding of a drug product shall have education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions. Training shall be in the particular operations that the employee performs and in current good manufacturing practice as they relate to the employee’s functions. Training in current good manufacturing practice shall be conducted by qualified individuals on a continuing basis and with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them.”
What does this mean for manufacturers in the life science industry?
Manufacturers not only need to develop well-documented training programs, but they also need to document a standard baseline model of what their employees need to know in their roles. Training curriculums should be developed around baseline criteria. Of even greater importance to manufacturers is verifying that your training programs are effective.
Evaluating Training Program Effectiveness
Evaluating training program effectiveness is challenging and can be difficult to demonstrate. Here are several areas to consider when measuring your training program effectiveness.
- Planning is paramount to measure training effectiveness. During your program planning, you should identify learning objectives, what training outcomes you’ll measure and why, how often they will be measured, and how you plan to report on them. It helps to identify outcomes that are specific and quantifiable.
- When it comes to training in life sciences, simply documenting that a standard operating procedure (SOP) was read and understood isn’t nearly as effective as including a skills assessment with the SOP. Testing employees on the training they’ve participated in is one way to gauge program effectiveness. Passing test scores are specific, quantifiable, and can be tracked and recorded throughout the training cycle.
- Monitoring the success of your operation over time also helps you to determine if your training program is effective. Don’t wait until something goes drastically wrong. Ongoing random audits of your processes and procedures will help you to identify strengths and weaknesses in your training program. If you’re identifying errors, perhaps your training needs to be re-evaluated or you need to offer refresher training to employees in shorter intervals.
Keeping Employee Training Current
Most life science organizations focus on continuous improvement and as such, policies, processes, and SOPs can change frequently. It’s critically important to keep employees informed of these changes. While this too poses great challenges, they can easily be overcome by using a cloud-based validated learning management system (LMS) to manage and automate employee training. A validated LMS can help companies to reduce their risk, boost efficiency and optimize productivity, all while facilitating regulatory compliance.
What is a Validated LMS?
A validated LMS offers much of the same functionality as a traditional LMS; however, the validated LMS has unique features that support FDA regulatory requirements. Electronic signatures, versioning, robust data security, and a fully documented software development life cycle are what set a validated LMS apart from the rest. Validated LMSs are designed to be an integral part of the quality system for regulated organizations. A validated LMS helps organizations to deliver targeted training at the time of need.
Key Validated LMS Features
- Audit Trails: An audit trail is used to keep track of administrative actions performed in the learning management system. Audit trails must be readily available upon request and provide a comprehensive record of transactions in the LMS that includes the date, time, and user information for the employee that modified the record.
- Automated Reminder Notifications: An LMS that delivers automated email notification reminders can alert employees of their training status. Annual compliance training can be automatically renewed, thus supporting your overall compliance efforts.
- Electronic Signature: The FDA requires that when employee training is provided online, an electronic signature is necessary to document proof that the training has taken place. 21 CFR Part 11 is the part of the Code of Federal Regulations that defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records.
- Role-based Training Assignments: It’s essential that a validated LMS easily assign job-specific training programs based on a user’s role, job title, group, or similar delineation.
- Versioning Support: A validated LMS should support version control of training materials. Furthermore, all previous versions of training materials must be electronically stored and easy to retrieve.
It’s critically important that life science manufacturers ensure that their employees have the education, training, and experience, to perform their assigned duties, and they must be able to provide documented evidence of it. Following industry-wide best practices and having a validated LMS in place helps alleviate the administrative burdens associated with delivering a robust training program. If you’d like to learn more about how ePath Learning supports companies in the life science industry, contact us today.
Susan Distasio | eLearning Industry Crusader | ePath Learning, Inc.
About the Author: Susan Distasio is an eLearning Industry Crusader focused on advocating for advancement and change in the eLearning and professional development industry. An avid seeker of knowledge and continuous improvement, Susan is happy to share her research, observations, and thoughts regarding “all things related to learning and development.” When she’s not out on the learning crusade, Susan can be found with the wind in her hair riding her Harley or simply enjoying life with her husband, Steve, and her Siamese cat, Elvis, and with family and friends.