Between 2020-2023, the U.S. reported 107 medical device recalls; the most common recall was due to quality control. Emphasizing the need for manufacturers to maintain medical device quality and safety throughout the supply chain. Good Distribution Practice (GDP) is a set of international standards and guidelines that protect a medical device’s quality, safety, and efficacy throughout the distribution process.
How can Dokeos LMS provide medical device companies with the tailored training and record-keeping they need to be inspection-ready? In this article, our quality experts explain further.
What is Good Distribution Practice (GDP)?
Good Distribution Practice (GDP) is a set of standards and guidelines that make sure all medical devices maintain their quality, safety, and efficacy throughout their journey in the supply chain. By complying with GDP, employees store, handle, and transport devices in an environment that prevents contamination, damage, or mix-ups—protecting patients from defective and unsafe medical products.
Compliance with GDP is also important for meeting regulatory requirements. It also builds trust with stakeholders and reinforces your company’s commitment to quality and reliability.
Common challenges in implementing GDP standards
Ensuring compliance across global supply chains provides medical device manufacturers with a few challenges. This is mostly due to differing regional regulations, broken document systems, and inadequate training processes. Common challenges identified in the medical device supply chain include:
- Regulatory variability: local and international manufacturing regulations change across countries, affecting compliance and operational processes.
- Documentation errors: The most common documentation errors included missing, duplicated, unauthorized certifications, or incomplete training records, which delayed inspection readiness.
- Training and skill gaps: There is a lack of role-specific training for important tasks in the supply chain. This could be a result of a lack of tailored training or inadequate training content.
A centralized approach, such as that provided by an LMS, can help medical device manufacturers meet GDP compliance standards.
How to comply with Good Distribution Practices (GDP)?
GxP Training, in partnership with Dokeos LMS, provides high-quality, validated courses to equip medical device companies with the knowledge and skills they need to implement GDP principles and guidelines.
GxP Training offers a course called GXP2065: Good Distribution Practice, which provides learners with an interactive online experience. Learners thus gain a complete understanding of how to maintain supply chain integrity, as well as covering topics such as internal temperature mapping, guidelines for outsourced shipment contracts, GDP guidelines for receiving and dispatching, document retention, and risk mitigation.
Each course offered by GxP Training is:
- CPD/CEU accredited and 21 CFR Part 11 complaint, ensuring adherence with FDA regulations.
- After completion, each certificate is dated, traceable, downloadable, and can be validated online, ensuring inspection readiness.
- Routinely updated once a month to reflect the latest guidelines from regulatory authorities. You are provided one year of access to the course, ensuring up-to-date knowledge and access to the latest regulatory requirements.
Through tailored GxP Training courses, employees gain the knowledge they need to implement GDP standards with consistency, supporting a company-wide culture of compliance and operational excellence. A GxP Training catalog that you can easily integrate into your LMS platform. You will be able to train your employees on a compliant LMS platform and fully regulatory content.
How Dokeos LMS and GxP Training Help Ensure GDP Compliance?
Dokeos, in partnership with GxP Training, provides a catalog of content-rich and compliant training. Thus making sure that all your employees receive the correct GDP training for their roles and responsibilities.
Our platform provides your company with essential tools, such as video conferencing, multimedia content, adaptive quizzes, and real-world scenarios, creating engaging training experiences– ensuring your employees not only understand GDP principles but can successfully implement them in daily operations.
We also provide a centralized and secure training management center that consolidates all your training materials, certification records, SOPs, and employee progress into one place. Eliminating inefficiencies, duplicate records, and other errors associated with manual record keeping. Automated compliance tracking and audit-ready documents ensure inspection readiness.
Looking to get your team up-to-date? GxP-Training provides certified online G(x)P training courses for medical device companies with validated CEU/CPD accredited certificates. Helping ensure compliance with GDP and consistency across your supply chain.
Dokeos LMS streamlines operational workflows, ensuring data integrity and regulatory compliance and setting a new standard in training for GDP compliance. Sign up for a free trial today!
FAQs
What is Good Distribution Practice (GDP)
Good Distribution Practice (GDP) is a set of international standards that must be met to ensure the integrity and quality of medical devices and products are maintained throughout the supply chain. This makes sure that all medical products remain safe and effective for patients.
