As the bio/pharmaceutical industry has continued to evolve, workforces have had to adapt by becoming broadly knowledgeable, skilled, agile, and flexible. This changing environment has created challenges for bio/pharmaceutical companies and organizations due to a lack of professional training staff, availability of subject matter experts, budget constraints, measurements of training effectiveness, and associating training efforts and resources to the cost of quality.
Despite these challenges, it is important for companies to invest in practical, hands-on training to ensure the success of their operations. Training is critical to a company’s operations and contributes to ensuring delivery of a quality product. Patients expect that the people involved in the manufacture of their medicines are competent to perform the tasks involved in the process. In most cases, patients do not have the ability to verify that all the parties involved in manufacturing their medicine were properly trained. They rely on information that is readily available to them through the media and from regulatory authorities. But does this tell them enough?
Regulatory agencies require that training on good manufacturing practices (GMP) be conducted on a regular basis for those who are involved in producing pharmaceutical and biological products. While regulatory agencies have these requirements and expectations, they provide few specific details as to how the training is to be performed. They only specify that documentation is needed as evidence that the training occurred. However, in the changing manufacturing landscape, more and more frequently, regulatory agencies and their inspectors are requesting evidence that the training was not only conducted but also effective.
To date, no guidance document on training for industry has been made available by any regulatory agency or official (governmental, non-governmental, or industrial) organization. However, there have been several articles published that explain the practices in which companies should engage to ensure their employees are properly trained. Unfortunately, this lack of guidance may cause some in industry to think that training is a simple process, when in reality, it is not. Those who view training only as a means to being compliant with regulations are missing out on the benefits training can provide. Some companies are starting to recognize this by looking at training as an opportunity for skill development, knowledge transfer, and incremental learning to ensure robust process development and suitable/reliable manufacturing operations.
Why Invest in Training?
Companies benefit from training because it engages employees and keeps their skills current, which ensures that organizations have sufficiently trained talent to run an efficient operation. Pharmaceutical and biopharmaceutical professionals, including non-degreed process and other technicians, need to be broadly knowledgeable and capable of independent thinking, including being able to spot and resolve problems as they arise. For training to be an effective and efficient tool that contributes to performance, it must be done properly.
In ensuring a company is providing quality training for its employees, there are several things that need to be considered. Key elements of a quality training program include:
- Instructor/trainer credentials
- Well-written documentation with incorporated multimedia
- Hands-on activities and simulations
- Environment (classroom vs. hands-on)
- Opportunity to learn from failure
- Continuous/Ongoing learning (e.g., from deviations, quality near misses, CAPA, shift communications)
Regardless of whether training programs are conducted by in-house subject matter experts, third-party experts, or educational institutions, these programs must incorporate hands-on activities with on opportunity to assess the learning through knowledge or skill assessment. Any training program should equip students with job-related skills they can take back to their companies and apply immediately.
For example, the Parenteral Drug Association (PDA), the leading provider of science, technology, and regulatory information and education for the pharmaceutical and biopharmaceutical community, offers professional, hands-on training in a laboratory environme...
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