Quality and Compliance Solutions - PathWise : Solutions

PathWise

Solutions

PathWise provides Quality Systems training and consulting for FDA and ISO regulated industries. For over more than a decade, we have provided best-practices for QSR’s, cGMP’s, CAPA, ISO 14971, ISO13485, and other issues impacting the Life Sciences industry.

Training

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.

We specialize in the following training programs:

CAPA
Root Cause Analysis
Risk Management
Documenting Investigations
Conducting Internal and Supplier Quality Audits
Analytical Problem Solving
Quality System Regulation (QSR)

Consulting

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.

We’ve worked with many companies in the life science industry in efforts such as:

CAPA System Installation and Integration
Form 483 and Warning Letter Remediation
Management Control
Investigation Facilitation
Third Party Audit Preparation

PathWise not only provides an outside perspective to these issues, we bring proven best practices, tools, and processes. We’ve studied the best of the best in the life sciences industry, and bring an intimate knowledge of FDA regulations.

Learn more about our solutions for Medical Device, Pharmaceutical, or Nutraceutical companies.

Through training in PathWise Project Success managers learned a process for the selection and approval of projects. Team leaders and team members acquired the skills to accomplish projects on time and within scope.