An induction training course on quality management system for competent medicines authority personnel

Abstract

Evolving regulatory systems and global harmonization initiatives require authorities to have strong commitment to Quality Management Systems (QMS). A key to encouraging employees to participate in the quality process and contribute to the success of QMS is an efficient induction program. This study aimed to develop recommendations for an optimized QMS induction training course for a competent medicines authority. A questionnaire was developed and validated to explore the QMS induction program of international regulatory authorities and a focus group discussion was conducted to examine the current program of the local competent authority. Best practices that were identified from literature and the exploration of current practices were used in gap analysis. Twenty-six participants from different regulatory authorities answered the questionnaire. Out of the 25 organizations with an induction program, 12 have a standard operating procedure that is specific for QMS induction training. Mixed training methodologies are preferred by fifteen (15) authorities and in-person group session is the most applied method (n=17). The least applied method is the use of training software (n=2). Additional activities to engage participants include workshops (n=8), case studies (n=4), and role-play scenarios (n=1). Duration of induction training sessions ranges from 15 minutes to 14 hours with an average of 2.4 hours. All 25 respondents reported to have an internal induction program that is facilitated mostly (n=20) by quality personnel. Trainers or instructors administering the induction are typically quality managers or heads (n=23). Sessions are administered during the first month of employment in most of the authorities (n=20) where 9 of which conduct their training in the first week. The gaps identified were (1) need for standard operating procedures and guidelines specific to QMS induction training; (2) defined target for induction schedules; (3) topics such as awareness of employee’s contribution to QMS, and introduction of the Quality Unit; (4) identification of training objectives; (5) implementation of training evaluation; and (6) annual training program update. Developing a systematic and optimized QMS induction training program by exploring approaches from the international level supports the local competent authority’s commitment to maintaining quality in all organizational processes and continuous improvement.