Navigating Regulatory Training: Digital Transformation Strategies for a Smarter Pharma Workforce

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Optimizing training for performance in the pharmaceutical industry was a key theme at the PDA Regulatory Conference 2025, with discussions centered on moving beyond basic compliance to leveraging digital tools for more relevant and responsive learning. Industry experts Marc Glogovsky and Richard Jaenisch shared insights on the evolution of training methodologies and the potential of new technologies on Monday, September 8, 2025 in the session “Competency-Based Training and Digital Learning,” moderated by PharmTech editorial adivisory board member and Ask The Expert co-host Susan Schniepp, fellow, Regulatory Compliance Associates.

Why is training for performance a necessity in regulated industries?

Training is more than a checkbox; it is a legal requirement, said Marc Glogovsky, Business Unit Manager of Microbiology at ValSource, Inc., who emphasized that every person involved in operations must receive job-specific, ongoing training in Good Manufacturing Practices (GMP), delivered by qualified individuals. Unfortunately, training sometimes devolves into rote exercises lacking relevance. As Glogovsky observed, employees question modules like “lockout tagout” that have little practical connection to their duties. Effective training, he stressed, ensures personnel are “fit for purpose.”

This isn’t just theoretical. In 2024, there were 27 FDA 483s citing training deficiencies among 561 total for drug products, Glogovsky noted, a trend seen year after year. “If you're not giving them the proper tools, the proper training… you’re going to get some type of half-assed response… not in line with what the [GMP] expectations are,” he stated.

What are the common challenges facing traditional training programs?

Both speakers acknowledged major obstacles in traditional training. Glogovsky cited the overwhelming number of regulations across GMP, good clinical practice, good distribution practice, etc., skill gaps caused by evolving roles, rapid tech shifts, and high employee turnover. In-person training often strains resources, leads to disengagement, and can cause “burnout” for instructors and learners alike, he added. As Glogovsky joked, “If you give me training at 10:00 on a Monday, it's going to be a good day; you give that to me at 4:59 on a Friday, good luck.”

Richard Jaenisch, Director of Education and Outreach at Open Biopharma Research and Training Institute, echoed these points, stressing the “human factor,” noting that people switch organizations, and systems’ needs change swiftly.

How can digital transformation elevate learning management systems?

Digital learning management systems (LMSs)—from MasterControl to Veeva—are central to modernizing training. Jaenisch explained that these systems, accelerated by the COVID-19 pandemic, simplify audit readiness, allow easy tracking, and enable learning “anywhere, anytime.” Interactive features like quizzes within videos and global accessibility are advancing continuously. Micro-certifications are also becoming standard for validating workforce skills.

What roles do VR and AR play in practical skill development?

Virtual Reality (VR) and Augmented Reality (AR) transform hands-on skills training, said Glogovsky, who found VR “eye opening” for cleanroom work, letting staff see how actions alter airflow in a way impossible to replicate in person. Jaenisch described VR as invaluable for onboarding, reducing risk and costs, and supplying critical feedback on techniques like aseptic manipulation.

AR is a game-changer for “digital work instruction,” they both agreed. With AR, protocols and schematics overlay live equipment, and trainees can practice virtually using digital twins of facilities—essential for complex, unfamiliar tasks and equipment.

Is gamification an effective strategy for enhancing engagement?

Gamification applies game mechanics—points, badges, leaderboards—to increase engagement. Glogovsky noted it can “be quite engaging,” turning even reticent operators competitive. Yet Jaenisch cautioned that gamification doesn’t motivate everyone, joking that “Some people don't need no stinking badges” and explaining that misapplied gamification may favor “addiction over utility,” distracting from true learning. Extrinsic motivators like financial incentives and time off often work better, and gamified elements need purposeful, personalized integration.

How can generative AI revolutionize training content and delivery?

Generative artificial intelligence (AI) is reshaping workforce training, said Jaenisch, who called it one of the “two big fundamental changes” in digital learning. Key AI applications that he noted include:

• Content summaries: AI rewrites standard operatice procedures (SOPs) or training content for clarity and accessibility, especially for non-native English speakers.
• Quiz generation/assessment: Automated, adaptive quizzes measure understanding instantly.
• Personalized learning: AI fine-tunes curricula to individual needs.
• 24/7 feedback: Intelligent tutoring systems can support learners in real-time, offering tailored guidance.

At Open Biopharma, digital interactive SOPs use AI to analyze quiz answers deeply, giving specific feedback, even for partially correct responses, and tracking progress in detail. Glogovsky also noted AI’s usefulness for generating training visuals and materials.

What are the barriers to adopting new digital training tools?

Despite digital potential, adoption is challenging, according to Jaenisch, who pointed to the high costs of LMS and AI tools—an LMS can run tens of thousands of dollars, while sophisticated generative AI can cost hundreds of thousands to millions, he added. Implementing these systems demands robust data infrastructure, regulatory clarity (often lacking or inconsistent between the US and EU), and organizational readiness for change.

What does the future hold for biomanufacturing training?

Looking ahead, biomanufacturing training is moving toward a “unified, intelligent learning ecosystem.” Centralized LMS platforms, integrated VR/AR for skills building, carefully applied gamification, and micro-certifications will define future models. Overcoming obstacles hinges on phased pilots, commitment to compliance and talent growth, security by design, and ongoing measurement.

A digital-first mindset—rooted in compliance, ethics, and relentless improvement—will grow a skilled workforce. Glogovsky advocated, “I would like to see training done every day—don’t just slam someone with 75 days of training into one week.” Breaking training into daily sessions supports mentoring, sharing, and transparency. Jaenisch’s group plans daily 20-minute sessions with generative AI, enabling continuous learning and real-time progress tracking for both individuals and teams.