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:
- Good Manufacturing Practice (GMP)
- Good Laboratory Practice (GLP)
- Good Clinical Practice (GCP)
- Quality System Regulation (QSR) including CMDCAS
- Quality System Inspection Technique (QSIT)
- Clinical Evaluation Reports (CER)
- Computer Systems Validation (CSV) and other validation services
- Combination devices
- Internal auditing
- Quality Systems (QS) or specific QS elements
- ISO regulations, especially ISO 13485 and ISO 14971
- Process validation (IQ, OQ, PQ)
- Medical Device Directive (MDR, MDD)
- Many other customized services
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.
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Contact us to learn more & find out how Maetrics can solve your regulatory or compliance issues.