Introduction
Part III addresses the implementation, assessment, record-keeping, and evaluation of training modules.
Chapter 9 discusses assessing the trainee proficiency. Special attention is paid to the effectiveness of employee training, since any revision of procedures involves training. Four components to the process of developing assessments will be addressed:
1. The behavioral objectives of the training program must be identified, based on the relevant operational procedure and the Training Outline.
2. The kind of assessment must be determined.
3. Assessment materials must be prepared.
4. These assessment materials must be incorporated into the training module.
Chapter 10 addresses the pilot implementation of a training program that is required by a remediation. This chapter also considers the possibilities of training module improvement during the rollout period:
1. What is the relationship between pilot implementation of a remediation program and other pilot projects in the pharmaceutical industry?
2. What are the conditions that facilitate or inhibit the implementation of a learning product?
Turning to tactical and logistical matters, this chapter reviews the preparation for a pilot implementation, the conduct of a pilot implementation, and finally, the evaluation of a pilot implementation.
Chapter 11 considers the documentation of change efforts involved in a remediation, including training activities. Regulatory compliance, as it relates to training recordkeeping, requires that personnel touching the product be trained. FDA regulations, with few exceptions, do not address training records. It is important to review carefully the several cases where the regulations do apply and ensure compliance. It is equally important to ensure that the organization is not wasting time and resources overbuilding the training record-keeping process.
The fields that are necessary for training records, as well as necessary roles and responsibilities, need to describe the fallback process in case there are access or other system problems in a fully electronic approach to training record-keeping. Validated electronic training tracking systems should be employed to manage training records and training assessments in an effective manner.
Training records can provide data to justify budget requests. They can provide data to test the accuracy of statements about training.
Chapter 12 examines the possibilities of evaluating the ongoing change effort during the rollout period. This involves a formative evaluation of the remediation program. It is argued that formative program evaluation can utilize the full range of experimental and quasi-experimental designs, as well as any other approaches. This includes the possibilities of employing adaptive designs. Thereby, the data gathered in the evaluative effort can at the same time be made available to management, during the course of the training process, to allow decisions to be made about program improvement. It is important that the US Food and Drug Administration has recently expressed interest in the use of adaptive designs in clinical trials.
Chapter 13 considers the implementation of the remediation across the organization after all ongoing program improvements have been made. This chapter has three parts. The first part reviews the scope and impact of the FDA regulations of pharmaceutical manufacturing in general, and of training in particular. These regulations are comprehensive. Any person who touches the drug product, or who supervises that person, falls within the scope of the regulations. These regulations impact on these persons via written SOPs that provide comprehensive guidance for drug manufacturing.
These persons must be trained on these procedures insofar as they relate to the employee’s functions, prior to their touching the drug product. Hence the importance of ensuring that the final implementation of the training module includes all these employees.
Finally, the Training Outline, a controlled document including a Training Audience List, is employed by the originator of a new or revised procedure to communicate with each impacted functional area to determine which employees require training. Those employees’ curricula are revised to correspond to the new or revised procedure, ensuring they are trained on the finalized module before touching the drug product.