In industries such as pharmaceuticals, biotechnology, and analytical laboratories, employee training is not just a box-ticking exercise—it is a foundational requirement for maintaining compliance with Good Manufacturing Practice (GMP) standards. Training must not only be relevant, up-to-date, and documented, but it must also empower individuals to apply knowledge effectively in their daily tasks.

At QSN Academy, the training division of Quality Systems Now, we understand that every organisation’s training needs are different. Whether you are facing an audit, implementing a new electronic system, or scaling your team, a static, one-size-fits-all training approach will not suffice. This article explores why upgrading your training program is not only necessary but strategic, and how QSN Academy can support your compliance and learning goals—through course licensing, custom content, or complete training strategies.

The Regulatory Requirement for Ongoing Training

Regulatory bodies including the TGA, FDA, EMA, and WHO require that personnel in GMP-regulated environments receive initial and ongoing training in their responsibilities and the systems they use. This includes training in:

• GMP principles and updates

• Role-specific SOPs

• Quality systems

• Electronic system use (e.g., LIMS, QMS, ERP)

• Data integrity principles

Inspections frequently cite inadequate training programs as a root cause of deviations, non-conformances, and data integrity issues. Ensuring that training is structured, documented, and effective is therefore a core requirement for compliance.

Signs Your Training Program Needs an Upgrade

Many organisations rely on legacy training systems, outdated slide decks, or informal “on-the-job” knowledge transfer. While these may seem efficient, they often fail to meet modern compliance and operational standards. Common indicators that your program needs an upgrade include:

• Inconsistent onboarding for new hires

• Lack of traceability or version control in training materials

• Repeated deviations linked to knowledge gaps

• Inability to produce comprehensive training records during audits

• Unclear responsibilities for training ownership and delivery

If any of these issues sound familiar, now is the time to reassess your approach to training.

Course Licensing: Scalable Access to Trusted Content

QSN Academy offers course licensing options for organisations that want reliable, regulatory-grade content delivered within their own learning environment. Our pre-developed courses are crafted by GMP and regulatory compliance specialists and are regularly updated to reflect current industry standards.

Licensed courses can include:

• GMP induction and refresher modules

• Good documentation practices (GDP)

• Data integrity fundamentals

• Quality risk management

• Deviation handling and CAPA

Organisations can host this content on their internal Learning Management System (LMS), assign it to users, and track completion and competency. Licensing is ideal for companies that need consistent, scalable training that aligns with best practice without the burden of in-house development.

Custom Content: Tailored for Your Processes and Culture

While licensed content offers efficiency, customised training delivers precision. QSN Academy works with organisations to develop content tailored to your SOPs, systems, and operational language. This approach ensures training is directly applicable and relevant to the learners' day-to-day responsibilities.

Custom content development can include:

• Process walkthroughs based on your actual workflows

• Animated simulations of system use (e.g., eQMS, batch record systems)

• Case studies drawn from real events at your site

• Interactive assessments that test critical thinking

All content is designed in line with adult learning principles and includes compliance with 21 CFR Part 11 and Annex 11 where applicable for electronic records and signatures.

Comprehensive Training Strategies: From Design to Execution

For organisations looking to completely redesign their training systems, QSN Academy offers end-to-end training strategy services. This includes:

• Training needs analysis (TNA)

• Role-based training matrices

• Competency frameworks

• SOP and curriculum mapping

• Learning Management System (LMS) integration

We work with QA, HR, IT, and operational leaders to ensure the training strategy is aligned with your business goals and regulatory obligations. Whether you are preparing for an audit, implementing a new facility, or remediating compliance issues, a strategic training overhaul can reduce risk and improve outcomes across the board.

Supporting the Go-Live Phase of System Implementations

Introducing a new system—whether it be an eQMS, LIMS, or ERP—requires comprehensive training to avoid errors and disruptions. Go-live periods are high-risk phases for compliance and performance. QSN Academy supports these transitions with focused learning interventions, including:

• SOP-aligned process walkthroughs

• Step-by-step system simulations

• Train-the-trainer modules

• Rapid response feedback mechanisms

Our training ensures that staff are not only technically competent in the system but understand how its use integrates with broader GMP compliance requirements.

Measuring Success and Driving Continuous Improvement

An upgraded training program must be measurable to be effective. QSN Academy supports clients in establishing KPIs for training effectiveness, including:

• Assessment pass rates

• Deviation trends linked to training topics

• SOP adherence rates

• Audit observations related to training

• Employee satisfaction and confidence levels

We also support clients with periodic training program reviews to ensure content remains current, relevant, and fully aligned with evolving regulatory expectations and business operations.

A Partnership Approach to Compliance Training

At QSN Academy, we don't just provide training content—we become a compliance training partner. This means:

• Collaborating with SMEs to co-develop and review content

• Aligning with your internal policies and quality frameworks

• Staying responsive to emerging compliance risks and inspection findings

• Offering flexible delivery modes including on-site workshops, remote learning, and LMS-integrated modules

This partnership approach ensures that your organisation is not just meeting training requirements, but proactively building a culture of learning and continuous improvement.

Conclusion

Upgrading your training program is not a cost—it is an investment in operational excellence and regulatory assurance. In a sector where compliance errors can halt production, trigger recalls, or result in enforcement actions, well-trained personnel are your first and best line of defense.

Whether you need off-the-shelf GMP courses, bespoke content aligned with your site-specific workflows, or a complete overhaul of your training strategy, QSN Academy can help.

Let’s talk about how we can support your compliance and learning goals. Visit www.qsnacademy.com.au to explore our training solutions, or contact us directly to schedule a discovery session with our compliance education specialists.