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Our mission:

In a globally regulated life science industry, PathWise provides proven methodologies in quality and compliance through hands-on and practical solutions that ensure compliant, effective, and efficient quality systems. PathWise focuses on a solutions-based approach to solving client issues. We help simplify the necessary concepts and processes, ensuring a quality system program that conforms to industry and regulatory standards. We strive for excellence and quality in all that we endeavor and keep up-to-date with applicable regulations and emerging industry trends.

Our vision:

We are the leading, global provider of quality systems solutions. We partner with life science organizations to ensure quality, safety and compliance in our world’s healthcare. We deliver the methodology and tools to ensure compliant, effective and efficient execution of quality system requirements. For over 20 years, we have worked with the best in the life science and manufacturing industries, have led global rollouts of quality systems and driven regulatory action remediation efforts for many of the Fortune 500 companies in the Life Sciences industry. PathWise brings an intimate knowledge of regulatory and compliance standards.

What makes us unique?


Our instructors utilize a “how-to” approach to learning, using a blended application of classroom exercise, and real life experience. We utilize a pool of highly specialized experts to fulfill all client commitments. These individuals are veterans in their fields with specific experience in an assortment of contexts. Our trainers include quality, manufacturing, and auditing professionals from the Life Science industry; ex-FDA investigators; and Lean-Six Sigma black belts – hand-selected to best suit our client’s needs.


PathWise sees all implementations through adoption to implementation and provides multiple avenues of on-going support. We maintain a high level of involvement with our clients as new skills, systems, and processes are internalized and put into practice.

Our core values:

We commit to…

  • Quality and excellence in everything that we do
  • Strategic management and long-term relationships
  • Fostering individual growth and team development
  • Integrity and loyalty
  • Prosperity
  • Openness
Show all training delivered by PathWise


Classroom / Public
Auditing and Quality Management Length Price Location Reviews
Root Cause Investigations 8 hours 795 USD San Diego
5.0 (4)
Technical Writing and Documenting Investigations 12 hours 1,395 USD San Diego
On-site / Company-specific
Auditing and Quality Management
Inspection Readiness 16 hours North America
Lead Auditor 16 hours North America
5.0 (2)
Technical Writing and Writing for Change Control 16 hours North America
Technical Writing and Writing SOPS 12 hours North America
Technical Writing and Writing Validation Documents 16 hours North America
Train the Trainer 16 hours North America
Quality Control
Investigations and CAPA Training 2 days Nationwide
5.0 (5)
Business and Management
Risk Management
Quality Risk Management Training 2 days Nationwide
5.0 (3)
Communication Skills
Writing Skills
Technical Writing Training 2 days Nationwide
5.0 (5)
Auditing and Quality Management
Good Clinical Practices (GCP) Online
Inspection Readiness Training Online
5.0 (3)
Quality System Regulation Training For Medical Devices Online
Business and Management
Effective Meeting Management Online
Current Good Manufacturing Practices Training Online
Electronic Records and Signatures Training Online
Good Clinical Practice Training Online
Good Documentation Practices Training Online
Human Resources
Performance Management
Introduction to Human Performance and Factors Training Online
  • = Available in Spanish

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Hans Willams, VP Operations
After receiving training through PathWise, we certainly see a general improvement in our CAPA process, including Root Cause Analysis and Documentation. There is also a reduction in the number of open CAPAs, resulting in less people being involved and less pressure for our organization.
Becky Fletcher, Quality Supervisor
The course was very beneficial because it including important information in regards to root cause analysis. It teaches others to be detailed oriented and to provide concise and thourough information. Furthermore, it allows center directors and QAS to work as a team and find better solutions to problems.
Martha Larence, Associate Director
I enjoyed the case studies, and reviewing all of the root cause analysis methods, one of which I wasn't aware of (is/is not). I also enjoyed practicing what we learned, such as covering interviewing techniques with break-out groups. The interaction between [the instructor] and the participants made for a healthy dialogue and learning experience
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Training reviews
Institute rating
Based on 22 reviews