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Pharmaceutical Technology REGULATORY SOURCEBOOK DECEMBER 2019 9 University of Puerto Rico. NIPTE members have been moving toward integrated multidisciplinary courses that emphasize problem solving and criti- cal thinking and include real-world problems, says Hussain, while also including certification to track continuous learning and improvement. Quality will ultimately depend on understanding the customer. Shame, blame, retrain? Corporate training programs can also be an obsta- cle to building a quality culture. "In organizations with a lower level of quality culture maturity, we often see the 'shame, blame, and retrain' approach being used. This is no longer acceptable to regula- tors," says Calnan. "The onus is on companies to create good on- boarding and training processes to address the gap between university training and required on- the-job knowledge," Calnan says. "But many orga- nizations still use traditional onboarding, where success is often based on how many people signed up to train on whatever the topic is, rather than how well they mastered the material," she says. In- stead, she says, companies need to look at how tacit knowledge can be transferred between teams and coaches and mentors. Technologies such as augmented and virtual re- ality can be useful because they allow the subject matter expert and the trainee to confer directly. Calnan notes a course that one company uses to train employees on column packing for chro- matographic skids. "This is a very specific activity that can cause major problems if done wrong, but, for orphan drugs, operators may only be making two batches a year. Virtual reality refreshes their knowledge and lets them walk through the proce- dure the day before," she says. Hussain sees professional development as crucial to corporate training programs. "Deming empha- sized appreciation for systems and the psychology of change. That's where emotional intelligence comes in and where we use the term 'culture of quality'," he says."You need a critical mass of lead- ers who are self-authored and self-transforming in order to achieve what Harvard education profes- sor Robert Kegan called 'orders of consciousness'" (13), he says. Those leaders must bring the rest of the staff up to support continuing education and continuous professional development. Quality will ultimately depend on understand- ing the customer. When she visits companies, Cal- nan says, operators and technicians usually can't tell her who the patient is that they are manufac- turing products for. But even companies that can- not afford "patient engagement days" can bring the patient into their manufacturing and quality efforts, says Calnan. "Why not have a lunch-and-learn session on cor- rective and preventive action (CAPA)? Take the last three complaints, get the team together and talk about them and how they might have been avoided," she advises. More advanced technology such as PAT, model- ing, and AI can play a significant role in improving quality. However, many smaller companies often complain that they cannot invest in new technol- ogies. Chen Ooi disagrees, because the potential savings and benefits of using the tools can far sur- pass the cost of investment. "People need to think about creative ways of stimulating the use of new