Introduction
This part provides an overview of the development of several kinds of GXP training modules.
The preceding chapters have presented three main topics:
1. A problem is observed in a manufacturing process, and an investigation and root cause analysis (RCA) may ensue. The investigation may lead to the development and execution of a CAPA plan. The CAPA plan may lead to revisions of the process and associated procedures (SOPs).
2. Should a SOP be revised as a result of CAPA, it should be subjected to critical review to ensure that the revision adds value. In light of the complexity and criticality of the process that is reflected in the SOP, the review can take one of several forms – it can be a management review, a SME review, a real-world challenge, or an experimental design study.
3. An SOP is based on a template, into which processspecific content is entered. The SOP provides a sequential list of activities (tasks) that, taken together, are sufficient for the successful completion of the process. In parallel to the list of activities is a list of personnel (job titles) who are responsible for completing each task.
This means a newly revised SOP is in place, revised to address the problem presented, and critically reviewed to ensure that value is added. The question becomes: How to ensure that this version of the SOP is enacted in the ongoing manufacturing process? After all, personnel who are responsible for enacting the procedure are more familiar with the preceding version of the SOP. They must not only become aware that the SOP has been revised, but must become proficient in executing each task of the revised procedure. They must become compliant in the current manufacturing practice.
Part I began with the observation of a gap between the actual status and the normative status of some manufacturing process – a deviation, an excursion, an out-of-spec finding, etc. Once that gap has been addressed by an investigation, RCA, and remediation, insofar as the remediation has included the revision of one or more SOP, a second gap emerges. This is the training gap between the actual performance and the normative performance of employees impacted by the procedure(s). The logic of the two remediation processes – the primary remediation process to address the manufacturing gap, the secondary remediation process to address the training gap – is the same.
Figure II.1 displays the homology of the two remediation processes, with five phases compared and contrasted. In the second phase, investigation, RCA and CAPA characterize the primary process (as already displayed in Figure II.1, above). The secondary process abbreviates these elements in a review of training records, where the various curricular items and individual training plans (ITPs) that pertain to the impacted employees are analyzed. In the third phase, the question of the revision of the procedure and other document management issues are dealt with in the primary process. Correspondingly, training materials and assessment materials are revised as needed in the secondary process. In the fourth phase, the criticality and complexity of the activities that make up the primary process are assessed, and a critical review of the revised procedure is conducted. Likewise, a pilot implementation and formative evaluation of the training module can be undertaken in the secondary process. Throughout, the activities that characterize the secondary process tend to be more implicit that those of the primary process.
Chapter 5 examines the systematic process of planning or blueprinting a remediation training module or program. This systematic approach includes fitting the proposed remediation into the larger programmatic framework; it involves outlining the remediation program in terms of a systematic template, the Training Outline; and it includes the need for securing management approval of the outlined remediation.
Chapter 6 addresses the development of training program content, focusing on developing a New Employee Orientation (NEO) program. Various features of a typical NEO program are treated, including both program content and presentation:
(a) A scenario based discussion of regulatory overlap is sketched, as well as appropriate employee responses.
(b) This is followed by an episodic approach to the history of the US Food and Drug Administration. These episodes are employed as illustrations of the process of continuous improvement (i.e., identification of problems [deviations], investigation and root cause analysis, and remediations).
(c) Finally, several aspects of the organization of a NEO program are presented, including the necessity to coordinate the program across several departments.
Chapter 7 is a further consideration of training program content, focusing on developing the content of Continuing GMP Training programs:
(a) At the beginning of the development of program content, all relevant regulations and guidances – that is, statements that provide the framework for program content – must be taken into account. The interpretive nature of these statements, and the role that risk assessment plays in organizational response to gaps (deviations) between the statements and ongoing organizational behavior, are stressed.
(b) Next, organizational resources that are available for the delivery of the program must be identified.
(c) The major sources of content that are available for the remediation program must be identified. In the illustrative case of continuing cGMP training this includes regulations in 21 CFR 211; written procedures required by these regulations; topics mentioned in FDA guidances; FDA warning letters; and the organization’s own records of deviations, investigations, corrective actions and preventive actions, and quality complaints.
(d) Finally, any logistical issues in the delivery of program content must be addressed, for instance, the frequency with which this training should be scheduled.
Chapter 8 addresses the qualification or certification of employees, above and beyond training, in regulated industry. Specific attention is given to employee qualification and SME qualification. Next specific employee qualification considerations are addressed, including employee qualification as process, qualification status, and measures to demonstrate qualification. Qualification may be demonstrated by use of a skills demonstration assessment checklist. The rationale for qualification highlights the role the qualification process plays in deviation investigations and RCA.