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An often overlooked need related to making DSCSA compliance long-term sustainable is for a well defined and managed training program. In many of the recent FDA 483 & Warning Letters, it is clear that regulators want to see well documented evidence that all associates who have roles in DSCSA are fully trained. Central to ensuring compliance is evident is the need for well managed training courses and training completion records.

In reviewing FDA 483's related to DSCSA, we noticed a pattern of trading partners receiving observations related to inability to demonstrate training compliance. The following is an example of an observation related to a notice from an FDA inspection:

"Your firm lacks training programs to ensure that the systems and processes for verification are followed, nor maintains the training records for employees trained on receiving and identifying suspect and illegitimate products"

As we have helped clients implement and sustain DSCSA compliance processes and systems over the past 12 years, the topic of training always arises as launches approach. Often training is managed as part of the implementation but loses focus once the project teams have rolled off or on to other efforts. It is not uncommon for organizations to spend significant time and budget on training courses, only to have them become unmanaged or obsolete in 2-3 years. In order to ensure your organization remains fully compliant, we suggest considering some important points

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1. Assess knowledge gaps and develop clear plans to resolve.
2. Develop a roles-based approach to ensure the right level and content of training for the right stakeholders.
3. Make sure your organization owns the training and don't expect templates to replace well managed processes.
4. Ensure the people developing and managing your training are well informed of DSCSA, systems, processes, standards, and organizational specifics.
5. Make sure you have a long-term strategy for keeping your training up to date as things evolve. Ten Count is proud to offer a training subscription platform built with industry leaders with a comprehensive approach that include industry best practices, business operations,and system perspectives.

We have also found occasions where trading partners have been suprised to have regulators discover that they are leveraging copied text from service or solution provider templates that they have seen at other trading partners. This causes immediate red flags for inspectors who will quickly ask to see evidence that the processes is well understood and training documented.

The Bottom Line

DSCSA training is no longer optional—it’s a necessity. Companies that invest in role-based, current, and practical training position themselves for smoother audits, stronger trading partner relationships, and most importantly, safer outcomes for patients.

At Ten Count Consulting, we offer role based training courses that can be easily added to your LMS or managed by your training leaders in our DSCSA training platform.

Consider having us demonstrate our training solutions built by deeply experienced resources with a blend of business, technical, standards, and best practice knowledge.

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👉 Ready to strengthen your DSCSA training program? Contact Ten Count Consulting today to learn how we can help your team prepare with confidence

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