An increasingly critical part of GMP training is ensuring that every employee has received sufficient education and training regarding key processes in the manufacturing of a product. Companies must also provide detailed documentation regarding the scope of its training programs and dates of completion for training modules. Failure to provide detailed evidence of employee training programs may result in warning letters or sanctions by the FDA.
The FDA's increased focus on training programs
In recent years, the FDA has increased its review of training records and quality control procedures for regulated companies. With manufacturing problems frequently being linked to improperly trained personnel, the FDA has identified training as an area that requires sustained focus.
Training programs have become increasingly important over the past decade as companies lose seasoned employees due to retirement or layoffs. When companies are staffed primarily by contract workers and new hires, effective training becomes even more critical as a smaller percentage of employees have experience working with pharmaceutical products. Companies that have reduced their training budgets or plan to do so in the near future should proceed with caution.
Measures to improve your company’s employee training program
In the world of FDA investigations, a verbal acknowledgement of the existence of an employee training program is not sufficient. FDA standards require companies to demonstrate sustained dedication to properly training employees. Below are five measures that will help a company build a training program robust enough to withstand FDA scrutiny:
- Management should periodically review employee training records
- Feedback from training managers should be solicited on a regular basis
- Companies should regularly evaluate training programs
- Improvements to existing training programs should be documented
- Companies should utilize a trusted software system to facilitate training automation and efficiency
By devoting attention and resources to completing these tasks, Management can demonstrate how employee training is a vital component of a company’s quality culture. The introduction of a software system to efficiently track training compliance, instead of a manual/paper-based solution, is a particularly pivotal step as it allows a company to systematically analyze training events against performance indicators.
The benefits of an electronic quality management system
An electronic quality management system (eQMS) allows a company to more accurately measure and monitor the workforce and the impact of training events. Specifically, it allows stakeholders to identify trends, supply chain inefficiencies, and training opportunities. While most companies do a good job of using electronic systems to track sales performance, too many companies fail to introduce any electronic systems, like an eQMS, to general users. The introduction of an eQMS for all employees —from the C-suite to shift workers in the warehouse — helps elevate manufacturing companies by improving their efficiency, downtime, and overall quality culture.
Strengthen and solidify your training program with an external audit
After taking measures to solidify a detailed and effective training program, company officials may wish to undertake one final step in an effort to safeguard their training program. Scheduling an external audit is a move that will help confirm a company’s compliance with FDA training regulations.
During an external audit, a trained team of professionals may review training records, employee resumes, certifications, and training activities to screen for deficiencies. Auditors will highlight strengths and weaknesses in a company’s training program and provide useful suggestions for maximizing program effectiveness.
How to integrate training into your company’s culture today
By investing in an eQMS for your company, you are demonstrating your commitment to meeting FDA compliance standards for GMP training. An eQMS will infuse compliance tracking into your company’s daily electronic operations, demonstrating your commitment to manufacturing the highest quality products.
If you're concerned about an FDA inspection at your site, here are some tips to help you stay organized and prepared.