Across the life sciences industry, maintaining compliance is never a fixed destination. As new standards and regulations are issued, there is always more to learn, understand, and put into practice.
Maetrics’ training services deliver the instruction needed to fully understand the global regulations and how they should be applied to day-to-day operations. Our sessions provide more than a summary or cursory review; we offer in-depth interpretations of compliance regulations and how they apply to each level of an organization as well as its service providers.
Providing Compliance Knowledge through Expert-Driven Programs
Our training programs are customizable to meet specific client needs by focusing on the most relevant compliance issues, presented in a platform best suited to the enterprise. We offer off-the-shelf courses that allow an independent self-study path, a series of public training courses known as Maetrics Education which deliver real-life strategies for overcoming the latest compliance challenges, as well as customized courses tailored to meet your specific needs. Maetrics Education sessions are held at either a Maetrics location or at a client’s facility, with core topics covering regulations, quality, sterilization, and contamination control and microbiology.
Maetrics bases its training services on the ADDIE framework: Analysis, Design, Development, Implementation, and Evaluation. Our approach is to analyze the client’s specific needs and personnel, consider the different training possibilities and then develop an effective program. After rolling out the training, we follow up with an evaluation to determine how successful the program has been.
Our training courses can be implemented as a standalone program or be customized to a client’s unique requirements and cover a wide variety of subjects, including the following:
- CE Marking 93/42/EEC and the new MDR
- Creating a Technical File / Design Dossier
- Risk Management – EN ISO 14971
- Post Market Surveillance and Adverse Event Reporting
- Process Validation
- EU and US Design Control Requirements
- EN ISO 13485:2016 Internal Auditor
- Understanding EN ISO 13485:2016 Medical Devices
- Sterilisation – Ethylene Oxide (EtO)
- Sterilisation – Gamma & Electron Beam
- Microbiology for Compliance Teams
- Cleanroom Good Manufacturing Practice (GMP)
Although Maetrics can provide unique and customized training platforms, we also provide customized “train the trainer” programs. These programs are typically executed as part of our consulting projects, allowing for full implementation of our solutions and allowing our clients to achieve a self-sustaining process. We can also audit a client’s internal training programs to evaluate their effectiveness and determine if new approaches should be developed.
Within the life sciences industry, training is mandatory for those participating in the development or production of any regulated products. Devising strategies for ensuring that professionals receive the instruction they require is a significant task, and Maetrics’ training services deliver the knowledge needed to stay compliant and prepare for future business growth. All courses are delivered in English.
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Contact us to learn more & find out how Maetrics can solve your regulatory or compliance issues.