If Training Is So Easy, Why Isn't Everyone in Compliance? - - BioPharm International

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If Training Is So Easy, Why Isn't Everyone in Compliance?


BioPharm International


What constitutes good training for employees engaged in pharmaceutical manufacturing? Many pharmaceutical companies think they know the answer: "We give our employees copies of the applicable SOPs to read, and they sign a form stating that they understand them." But reading a document is not the same as receiving training on a process or procedure.

In recent years, FDA has cited a growing number of pharmaceutical companies for deficiencies in their training programs - despite the fact they can produce volumes of signed records showing their employees have read the SOPs.1


Figure 1. Schematic of a training quality system.
Why are these records insufficient for FDA compliance? Because the pertinent question for training is not, "Can you prove that your employees have read the SOPs?" What the FDA wants to know is whether you can prove your employees understand the procedures and can perform them in accordance with the SOPs. To be able to confidently answer "yes," manufacturers must have training programs that are carefully designed, effectively delivered, regularly evaluated, and frequently updated - in addition to being well-documented. Such programs do not have to be overly complex or burdensome to be successful. In fact, complicated and tedious training can impede compliance just as much as an underdeveloped program.

FDA regulations covering training for employees involved in pharmaceutical and medical device manufacturing (such as 21 CFR 211) are very broad and subject to interpretation. Although FDA does not provide detailed guidelines for doing so, the effectiveness of your training program should be validated by a formal evaluation program. Each company is responsible for establishing its own monitoring procedures to show that employees not only attended training courses but that specific messages were received and understood.

While FDA compliance is critical for pharmaceutical companies, it is not the most important reason to have effective employee training programs. Every manufacturer should be concerned about training because it is an essential component of quality. In the demanding environment of pharmaceutical manufacturing, companies cannot maintain high-quality production without high-quality training. Just as every manufacturing process must be thoroughly tested and proven to deliver consistent results to maintain product quality, effective training programs are essential to ensure that employees have the knowledge and skills they need to perform their jobs.

An Effective Training System Despite the lack of specifics in the regulations, there are a number of common elements that should be present in any effective training program

  • cGMP training for new employees
  • an ongoing cGMP curriculum that includes regular updates and refresher courses
  • a formal program to qualify instructors
  • a structured on-the-job training program
  • regular assessment of knowledge transfer
  • a training documentation process
  • a policy document describing the training program and the supporting SOPs.

Each of these elements plays an important role in the process of giving employees the training they need to do their jobs safely and correctly and also provide the necessary documentation to demonstrate that the training was performed properly.

cGMP Training for New Employees. Many new employees do not have experience in the pharmaceutical industry, so it is important to begin their training with an overview of cGMP basics and why these practices are vital to the welfare of the employee, the company, and the patients who will ultimately use the company's products. The course should include a discussion of the regulations (such as an introduction to Subparts A through K of 21 CFR 211) and the role of SOPs in maintaining quality in the pharmaceutical manufacturing environment. Although this course is especially important for those new to the industry, it should be mandatory for all new employees regardless of their previous experience. This training should occur as soon as possible after an employee joins the company - typically within the first week of employment - and should include a testing component to ensure that new employees understand the material.

Ongoing cGMP Curriculum. According to 21 CFR 211.25,

Training in current good manufacturing practice shall be conducted by qualified individuals on a continuing basis and with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them.2


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