06.7.2016 Jeff Thomas

    GMP Training - FDA is watching. Are you?

    GMP Training - Are You Watching it as Closely as the FDA Requires?

    Reasons for a Heightened Focus on Training and Quality Control  bigstock-Extreme-Peeping-Tom-5183323.jpg

    Training programs are under the FDA’s microscope because insufficient employee training has been identified as a root cause of defects. Additionally, the changing composition of the manufacturing workforce has resulted in an overall lower level of experience among production employees. As layoffs continue to occur and seasoned employees approach retirement age, the following changes have resulted:  

    • A loss of experienced employees
    • A growing percentage of contract workers
    • An influx of new hires with little work experience

    It is not easy for companies to compensate for this loss of manufacturing expertise, especially as companies feel pressured to reduce spending across the board. Bolstering training and educationprograms therefore becomes a necessity for companies seeking to maintain quality production.  

    How to Strengthen Your Company’s Training and Educational Initiatives  

    With the FDA’s increased focus on employee training, it is imperative that companies devote attention to improving their employee training programs. Below are five means by which your company can enhance its training initiatives:  

    • Designate a key member of your staff to oversee employee training
    • Develop an internal training library that houses all training-related material
    • Review training materials at least once each year to remove outdated items
    • Employ proven software to help automate the training process
    • Ensure that managers clearly document all training activities

    The above mechanisms demonstrate that employee training has become integrated into your company’s day-to-day activities. A specialized software system is particularly useful as it can track the impact of various training activities.  

    How Quality Management Software Can Improve Your Training Process  

    The introduction of an electronic quality management system (eQMS) will give your manufacturing organization a competitive edge in a growing marketplace. Below are some of the key benefits of introducing an eQMS to your company:  

    • An eQMS provides a framework to organize training documentation
    • The effectiveness of specific training programs can be measured
    • Best practices and inefficiencies among shift work employees are identified

    Each of these advantages is significant because they demonstrate a focus on training to FDA investigators. Additionally, an eQMS contributes to raising the overall level of efficiency of your company.  

    The Importance of Regularly Evaluating Your Training Activities  

    The sheer existence of a training program is not a sufficient indicator of compliance with FDA standards. FDA investigators look for evidence that a training program was developed with involvement from key staff and seek evidence that a training program has been regularly evaluated and improved. Ideally, you should employ multiple methods to evaluate the effectiveness of your training activities. Below are a few examples:  

    • Involve management and supervisors in the development of training modules
    • Periodically survey shift workers about training effectiveness
    • Regularly review data from your eQMS to identify best practices
    • Schedule an external audit to screen for compliance with FDA regulations

    These measures will show that training has become an integral part of your company’s culture.  

    A Proven Means of Facilitating Compliance  

    By enlisting the support of an industry leader with a proven electronic Quality Management System, you can ensure that FDA compliance tracking becomes a part of your company’s day-to-day operations. ZenQMS offers a unique electronic Quality Management System that facilitates compliance tracking. Please contact us to request a complimentary demo that illustrates our expertise in helping companies achieve compliance in the training arena.

    The FDA is casting an increasingly watchful eye on GMP training programs. Companies must raise the bar in the area of education and training development in order to achieve compliance with FDA regulations. In particular, a company should focus on maintaining comprehensive training records. Documentation should be as specific as possible and should include the subject of each training program and the timeframe within which the training was completed.  

    Published by Jeff Thomas June 7, 2016
    Jeff Thomas