Regulatory compliance is key for pharmaceutical workers, who are typically bound by a large number of rules. Simple process errors or regulatory violations can have significant consequences.
Here are five strategies that training professionals can use to improve compliance training when working with pharmaceutical companies.
1. Educate Management and Supervisors on Compliance
Supervisors play an essential role in managing day-to-day compliance. Without training, they won’t have the direction they need to guide employees confidently.
Many pharmaceutical trainers adopt a top-down approach to training. Instead of beginning with the rank-and-file employees who will be ultimately responsible for a business’s compliance, they aim to change company culture by beginning with top-level executives. The trainer will then move on to work with supervisors and other managerial staff before training all other employees.
This approach ensures all staff understands how their business can stay compliant. It also helps top-level management lead by example and more effectively guides compliance in day-to-day work.
The top-down approach takes more time to train the employees who actually handle compliance directly, but it’s more likely to create cultural shifts that help guarantee it at all levels. This is especially true for organizations undergoing significant transformations — like the move to bioprocessing 4.0 that many businesses are managing right now.
2. Be Aware of the Most Common Pharma Compliance Issues
Knowing where compliance tends to go wrong can help trainers more effectively educate trainees. Businesses that struggle with compliance tend to have one or more of a few common problems.
Missing or incomplete documentation is one failure point many trainers will see. The quality unit in charge of compliance must fully follow certain responsibilities and procedures, which must be available in the form of written standard operating procedures (SOPs).
Effective SOPs are living documents that the quality unit can alter as needed to ensure business compliance. They should be as clear as possible when it comes to procedures, roles and responsibilities.
The SOPs should also outline how procedures will be documented and discrepancies or variations from compliance will be reviewed. For example, most pharmaceutical companies generate waste that requires different disposal procedures if facilities want to remain compliant. Disposing of one type of waste with an approach that is acceptable for another may not be enough to keep a company compliant.
When this type of event occurs, the compliance team should generate a report describing how and why proper disposal procedures weren’t followed. It should outline steps the team can take to prevent similar events in the future.
Reviewing these SOPs and existing compliance documentation may help trainers understand where the business and its compliance team are struggling.
3. Take Advantage of Strategies Like Certainty-based Marking
Certain training strategies can help trainers understand how well trainees know the material they’ve learned.
Certain-based marking (CBM) is a strategy that helps trainers create more effective multiple-choice assessments. It’s been recommended by various learning and development (L&D) technology experts in the pharmaceutical training field.
Learners undergoing a CBM assessment provide an answer and an indication of their certainty for each question, ranging from “high” to “low.” The simple certainty marker for each question tells a trainer about someone’s confidence in their knowledge, taking some of the guesswork out of using multiple-choice assessments.
CBM assessments allow trainers to more effectively develop future lessons or review content based on problem areas or questions where trainees knew the correct answer but weren’t confident.
4. Utilize an LMS With Reporting and Tracking Features
The right learning management system (LMS) can significantly simplify the process of reporting and tracking trainee progress. It can also generate documentation a business may need to meet the Food and Drug Administration (FDA) or Health Insurance Portability and Accountability Act of 1996 (HIPAA) audit requirements.
Some LMSs also offer automated compliance management and certificate generation. These tools can help trainers ensure they follow all necessary steps and cover major topics when training a worker on pharmaceutical compliance.
Learning tools make it easier to include content like images, audio, video and slideshows in lessons, which offers additional learning and reinforcement materials for learners. They can also provide an official certification once training is completed.
5. Regularly Review Progress and Gather Learner Feedback
Trainers may also want to directly solicit feedback from learners. Trainees often have a valuable perspective and unique knowledge of industry compliance that can provide a better understanding of what they may need.
At certain steps in every course, asking learners what they think about the content may help trainers develop more effective strategies and ensure major topics are covered in depth. It can also help them eliminate any confusion and provide a clear teaching strategy.
These Tips Can Improve a Compliance Training Strategy
Effective training for regulatory compliance is essential for most pharmaceutical companies. Involving management, preparing trainees for common violations and using learning technologies can help improve compliance training and ensure businesses are doing all they can to meet regulatory requirements.