“Training is what helps turn the theory of quality into reality,” said Dave Hunter, product management director at MasterControl. Yet, for most companies in the regulated environment, quality is a concept manifested largely in paper instead of training through policies, SOPs, work instructions, manuals, and other materials.

It’s not enough to have your quality standards on paper. You have to implement and integrate them into your daily operations and prove to regulators that your standards and policies work. “Effective training should be a fundamental part of a company’s quality management strategy as it can help prevent many quality problems from ever occurring,” said Hunter.

In a regulated environment, training is a means to minimize (if not avoid) human error, a common cause of deviations and nonconformances. It’s no wonder that various standards and regulations, such as the following, require training as an integral part of the quality management system.

• FDA 21 CFR Part 211.25 for pharmaceutical companies
• FDA 21 CFR Part 820.25 for medical device manufacturers
• ISO 9000 2000 for general manufacturers and other businesses
• ISO 13485 for medical device manufacturers

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