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LIFESCIENCELEADER.COM JANUARY 2015 48 TRAINING BIOPHARMA MANUFACTURING cost pressures on biopharmaceutical manufacturing have primed development of single-use systems (SUS). Today, single-use technologies exist for almost all biopharmaceutical process applications. But capturing the inherent benefits of single-use technologies requires sig- nificant changes to current shop-floor procedures, process flow architectures, and facility layouts. While multiple studies confirmed the positive impact of SUS on capital and operational expenditures (CAPEX & OPEX), these studies also indi- cated that various activities normally automated in traditional facilities were again executed by operators manually when implementing SUS. This change of the shop-floor work environment driven by introducing SUS now requires adaptation of current competencies to mitigate risk of GMP noncompliance and process inconsistencies. This means replacing the current GMP compliance- driven, SOP-based push–the-button approach, with an efficient education and training approach focusing on hon- ing operator competencies and skillsets. Many activities executed in biopharma- ceutical facilities are very similar to — and/ or as regulated as — the ones carried out in industries such as food processing or air- craft maintenance. These other industries commonly employ apprentice programs to help quickly educate their operators. For example, Kraft foods has developed two- and four-year apprentice programs where students learn (from mentors and in classrooms) how to maintain either com- plex manufacturing equipment or to run high-volume manufacturing processes. Student skills are honed to enable them to contribute immediately and meaningfully to the business. This kind of success further supports the implementation of apprenticeships in the biopharmaceutical industry. As outlined earlier, current approaches are fulfilling GMP compliance despite being unsuccessful with risk mitigation and process consistency. Therefore, novel, simple personnel education and training methods that bridge the gap between proven apprenticeship methodology and GMP requirements/constraints are required to move away from the current situation. PARADIGM SHIFT IN PERSONNEL TRAINING AND EDUCATION Over the last few years, training and edu- cation programs have been developed that don't put a manufacturer's GMP compliance at risk but still significantly increase operator capabilities and matu- rity. The approach consists of three tiers that are interconnected through enriched interactive ebooks and dedicated videos showing the activity to be executed in its process conditions and context of the manufacturing environment. Each activity is broken down into key steps along with process logic and timing. TIER ONE: EDUCATE THYSELF In the first tier, students are educated at their own pace by watching training videos and using ebooks related to their job function(s) as often as needed to help gain ownership of the tasks. Following this self-education, students review the content under supervision of a trainer. The trainer can stress specific and important information to take into con- sideration while assessing a student's learning curve. This step can be done face to face in workshops or through a Web-based platform. Quizzes made up of OJT images and videos help trainers further assess and validate each stu- dent's learning success. TIER TWO: EMBED INTO QUALITY MANAGEMENT SYSTEM In the second tier, the content of the video is transformed into a series of pictograms identifying the relevant steps. The picto- grams create the link between the SOP and the lessons learned in tier one. TIER THREE: SIMPLIFY ACCESS AND GMP COMPLIANCE In the third tier, a sticker showing the most important pictograms of the illustrated SOP is placed directly at the point of use. This approach ensures operators have access to the most rel- evant information of the activity each time they execute it. Furthermore, these stickers allow trainers to educate and train students on the shop floor, leveraging the knowledge transferred in tiers one and two. THE PATH FORWARD The biopharmaceutical industry has embarked on a dead-end street when it comes to personnel education and train- ing. The current training approaches have exposed the industry to significant risks of GMP noncompliance and process inconsistencies priming enforcement actions from regulatory authorities. A paradigm shift is required that is inspired by methodologies proven in other highly regulated industries that ensure first-time-right success and pro- cess robustness by reducing operator error and process inconsistencies. The objective must be active involve- ment of students in the knowledge transfer rather than just relying on them to read an SOP. Furthermore, trainers must act as craftsmen, tailoring knowledge transfer to each individual's capabilities and needs. This approach makes trainers responsible for suc- cessful knowledge transfer, which is significantly different from the typical well-documented, "GMP-compliant" ex- cathedra teaching. L The objective must be active involvement of students in the knowledge transfer rather than just relying on them to read an SOP. A L A I N P R A L O N G VP, New Product Introduction & Technical Life Cycle Management, GSK Vaccines By A. Pralong OVERLOOKING GMP BIOPHARM EDUCATION/TRAINING CAN COST YOU – BIG TIME