Description

Overview: This presentation will answer some of the frequent questions of new trainers or training managers. These include: worker training requirements, the frequency of training, how do design an effective training program, who is responsible for training, training effectives and training documentation.

By examining the GMP expectations on training from different regulatory bodies (from the regulations and citations), attendees will be able to envision what to include in a GMP training program. In addition, an overview of the training system, including types of training planning, will offer considerations to make GMP training more effective.

Why you should attend: Regulatory agencies around the world 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. Documentation is also needed as evidence that the training occurred. More and more frequently, regulatory agencies and their inspectors are requesting evidence that the training was effective. While regulatory agencies have these requirements and expectations, they give few specific details as to how the training is to be performed; they do not say how it should be done. To date, no guidance document on training for industry has been available from any regulatory agency or official (governmental, nongovernmental or industrial) organization. Unfortunately, this lack of guidance may cause some in industry to think that training is a simple process. However, for training to be an effective and efficient tool that contributes to performance, it must be done properly.

Areas Covered in the Session:

Review of GMP regulatory expectations of training (FDA and EU)
Recent training-related citations
High-Level description of a training system, including elements (needs analysis through evaluation), basic training documentation, management, GMP training plans/planning, and trainers

Who Will Benefit: