Regulatory compliance training is important for personnel in a pharmaceutical company to remain current with appropriate regulations.
In preparation for announced and unannounced inspections by the FDA or other regulatory agencies, personnel should familiarize themselves with the latest national and international guidelines.
As such, pharmaceutical and medical device executives should understand what features are necessary for compliance training systems and how to maintain them.
What Are Compliance Training Systems?
Compliance training systems are programs designed to train employees on current regulations and how to adhere to them.
These systems can be offered internally by a pharmaceutical or device company or externally by a consulting firm. Compliance training systems encompass a variety of subjects that range from auditing and conducting inspections on preclinical programs to managing and controlling documentation.
They also include training on Good Manufacturing Practices, Good Tissue Practices, and Good Laboratory Practices. They offer training through webinars, onsite seminars, PowerPoint presentations, and other formats.
Important Features of Compliance Training Systems
Once pharmaceutical or device executives have determined that a compliance training system is needed, they should determine what curriculum they require, what function it should serve, and in what format it should be administered.
As such, they should consider what the scope of the curriculum should be, how it will fit into their company's budget, whether the associated courses should be taught virtually or onsite, and who should enforce the curriculum.
1. Determining relevance to FDA regulations
Of foremost importance in administering the compliance training system is its degree of relevancy to the FDA’s current guidelines and regulations. Compliance training should conform to current guidelines. If it is out of date, it may enable violations to occur. As such, the appropriate personnel should review the training and guidelines regularly to make certain that they remain relevant.
2. Defining and documenting a specific training program
Compliance training should also be well defined. One of the most common violations for which the Food and Drug Administration issues notices of violations to pharmaceutical or device companies involves procedures that have not been written down.
As such, all relevant training and standard operating procedures should be written down. Because a paper format provides less accessibility, the programs must be accessible via electronic means. Therefore, pharmaceutical executives should make certain that they have the appropriate infrastructure and technology to make these procedures available.
3. Choosing an appropriate training program format
The training programs should also be developed into a format that is understandable to the professionals who engage with them and to inspectors from the FDA.
If neither the professionals who engage in these trainings nor the inspectors from the FDA understand the programs, the programs are less likely to be effective and inspectors are more likely to issue violations. As such, professionals should review them for readability and comprehensibility.
These programs should also describe ways of monitoring vendors and outsourced facilities, ways of monitoring the quality of ingredients, and appropriate procedures for accepting or rejecting ingredients. One common complaint voiced by the Food and Drug Administration is that training programs do not include appropriate procedures for managing vendors. Therefore, professionals should review systems to determine to what extent they comply with these procedural standards.
4. Including a method for measuring effectiveness
Finally, the compliance training programs should include some method of measuring effectiveness. Metrics used to monitor compliance issues should demonstrate improvements post training.
By making certain that compliance training systems are current, relevant, accessible, and comprehensible to employees, pharmaceutical executives can increase employees' chances of complying with them. This can result in a decreased number of violations issued by the Food and Drug Administration and an increase in compliance with their regulations.
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