Training Material

Training initiatives have evolved over time and currently there are many technological advances that can be utilized to manage training more efficiently.

In an ideal world, all companies would implement a World Class Quality Training Program for their most valuable asset – their employees. However, in the real world only a fraction of companies achieve this goal.

Under a quality system, continued training is critical to ensure that the employees remain proficient in their operational functions and in their understanding of cGMP regulations. Typical quality systems training would address the policies, processes, procedures, and written instructions related to operational activities, the product/service, the quality system, and the desired work culture. Under a quality system, training is expected to focus on both the employees’ specific job functions and the related cGMP regulatory requirements.

When operating in a robust quality system environment, it is important that supervisory managers ensure that skills gained from training be incorporated into day-to-day performance.

Key Questions:

•  What are the specific needs and priorities of the workforce?
•  Does the training match the expectations of the employee’s job description?
•  What levels of training are needed – GMP, job-specific, SOP-specific, and others (e.g., safety)?
•  Who is responsible and accountable for training?
•  Are a formal, approved Quality Training Program / Plan / Strategy in place and implemented, including metrics?
•  How are training activities and logistics documented and managed – manually or using a Learning Management System    (LMS)?
•  What training is already in place and what is its quality?
•  Does existing training meet current regulatory expectations with regards to content, measurable effectiveness, and documentation?
•  What types of training media are most appropriate for a company?
•  What types of training media are available and utilized?
•  Are the Trainers qualified to present the content?
•  What training record / data are recorded and readily available for an inspection / audit?
•  Is training data current, accurate, of high integrity and trustworthy?

How We Help?

•  Evaluation of training needs
•  Provision of training to satisfy these needs
•  Evaluation of effectiveness of training
•  Documentation of training and/or re-training
•  Implement cost-effective training processes through automation.

Business Impact:

•  Mitigate compliance risk by meeting FDA and international regulatory requirements and expectations.
•  Increase productivity of the training staff through training process automation and the workforce receiving the training by “doing it right the first time” so there is less rejects, re-work, and re-testing.
•  Utilizes interactive models of instruction to capture and maintain an employee’s attention, making the learning experience interesting and engaging, thus increases the probability that the employee will learn the material.
•  Includes an assessment yielding measurable results that demonstrates that an employee has not only learned the material presented, but can apply this newly acquired knowledge to his/her duties/activities.
•  A clear vision and plan supported by management and implemented by qualified personnel will ultimately yield the desired results

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