Risk Management
Effective Risk Management is a critical process for those under increased regulatory scrutiny. In the past decade, ISO 13485, ISO 14971, ICH Q9 and ICH Q10 have been recognized by the FDA as the standards to which all medical device and pharmaceutical companies should comply.
Now, more than ever, life science companies need strong risk systems in place.
Our Risk Management training and consulting solutions not only provide an outside perspective to these issues, they bring proven best-practices, tools, and processes. We’ve studied the best of the best in the life sciences field, and bring an intimate knowledge of regulatory standards.
* Source: FDA.gov
PathWise focuses on a solution-based approach to solving client issues. When risk management training is the appropriate solution, we help simplify the necessary concepts and processes, ensuring a quality system program that conforms to industry and regulatory standards. Our instructors utilize a how-to approach to learning, using a blended application of classroom exercise and real-life experience.
Whether it is remediation resulting from regulatory findings, (Form 483 or Warning Letter) or the objective is to improve quality and compliance before that happens, PathWise will work with your organization to deliver solutions. Our consultants go beyond prescriptive suggestions- we work in tandem with clients to create new systems or write new procedures.
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