Quality System Regulation (QSR)
Medical device manufacturers and distributors must establish and follow quality systems to help ensure that their products consistently meet applicable requirements and specifications. Over the last decade, beyond FDA, additional standards have been developed with include ISO 13485 and ICH Q10 which provide a common frame of reference for a systems-based approach to quality.
PathWise provides insight on how these regulations and standards need to be addressed to improve quality within the organization.
KEY BENEFITS
Our QSR solutions share insight into the following:
- Regulatory requirements for your company and
department.
- How to address
common audit and warning letter
findings.
- Understanding the dos and donts
during external audits.
PathWise focuses on a solution-based approach to solving client issues. When 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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