A Comprehensive Approach to Training: Developing a Plan

September 24, 2014

Most pharmaceutical manufacturers have a training program of some sort. Yet few have a well-defined, written training plan that guides and integrates the training process throughout the facility. This plan helps ensure a facility accomplishes its goals consistently, according to its stanĀ­dards of quality, production, cost and safety.

The plan also helps meet the FDA’s requirements for GMP training. And while the agency provides no guidelines for conducting training, inspection citations show a clear preference for competency-based training.

Seven Steps

An effective competency-based training plan has seven key characteristics.

  1. Define line management accountability. Identify the people or units that have ultimate responsibility for creating and conducting effective training within the facility.
  2. Define training roles and responsibilities. To carry out the plan, you need a management hierarchy that covers all the bases, from the corporate training manager to departmental training coordinators, instructional designers and department trainers.
  3. Include quality oversight of training, including establishing recordkeeping requirements, change control procedures and performance criteria.
  4. Set out a systematic approach to training. Begin with analysis of your training needs and objectives, then move on to developing training materials and assessments, and don’t forget to validate your training process.
  5. Describe the implementation schedule. Consider how and when to train new hires, when existing employees need updates or refreshers and how often, and time periods for completing job qualification training.
  6. Delineate pathways for personnel qualification. Identify the steps you will require employees to take to qualify or re-qualify for job functions. These steps should allow the trainee to demonstrate competence and include a plan for those who fail to do so.
  7. Define other key terms and elements related to training at a site.

Each department should also develop its own training plan. This departmental plan should provide a schedule of training and retraining to ensure the availability of a sufficient number of qualified personnel to perform all job functions at all times.

Ultimately, the plan should carry the full weight and authority of other corporate directives, with the highest levels of management support for training as an essential component in the manufacture of safe and effective healthcare products.

In the coming weeks, we’ll take a more in-depth look at the phases of developing a competency-based training plan.

Contact Information:
Dave Gallup
GMPTraining.com, Inc.
18585 Coastal Highway
Unit 10, #149
Rehoboth, DE  19971