A word about our team.

QualityHub management consists of consultants who are ex-FDA Investigators and ex-FDA Compliance Managers. QualityHub, Inc. was founded by Timothy Wells after a 24 year career in FDA.

Our consultants are both ex-FDA Investigators and Compliance Officers, as well as private industry experts from the device and pharmaceutical industries. Our consultants have expertise in a wide range of technical areas. Some of these include: CAPA, Clinical, Complaint Handling, Document Control, Field Actions, Human Resources, Investigations, Laboratories, Management Controls, MDR, Process Mapping, Process Validation, Quality Principles, Risk Analysis, Software Validation and Part 11, Performance Scorecard, Stability, Sterilization, Supplier Management, Training, and others. Our average consultant regulatory experience is over 27 years.

Tim Wells, following a 24-year career at FDA, founded Wells & Associates in October of 2000. At FDA he was with the Center for Devices and Radiological Health (CDRH) Office of Compliance for 10 years. He was the Quality System Inspections Reengineering Team Leader, where he directed all aspects of the QSIT project. He was an FDA representative to the Global Harmonization Task Force (GHTF), Study Group 4 - Auditing. He served on the Field Investigator Certification Review Board. He also served as the Quality Program Manager in CDRH Office of Compliance.

Tim has worked in several locations in FDA headquarters and the field. He was the MDR Branch Chief and Branch Chief in the Division of Enforcement II; He also was a Small Business Representative, and Field Investigator. He directed and co-authored the QSIT Handbook and QSIT CD-ROM. He is an author of numerous articles and he is frequently a panelist on industry and FDA videoconferences and industry sessions on quality system inspections. He is a member of ASQ, FDLI, and RAPS.

Timothy Wells is one of the FDA Industries most sought after guides, with expertise in inspection strategies, regulatory compliance and quality system/cGMPs.

As the key architect and primary developer of the Quality Systems Inspection Technique (QSIT), and co-author of the Guide to Inspection of Quality Systems (QSIT Handbook), Mr. Wells brings an extraordinary level of expertise that spans more than 24 years in the FDA and in private industry.

Prior to leaving the FDA, Mr. Wells was involved in several major quality initiatives, including roles as Team Leader for the Quality System Inspection Reengineering Team at the FDA-Center for Devices and Radiological Health (CDRH), and as Quality Program Manager for the Office of Compliance at the FDA, Center for Devices and Radiological Health (CDRH).

Tim served as a member of the Global Harmonization Task Force, Study Group 4, Auditing, where he represented the FDA and the US in discussions of global auditing techniques. As a consultant, Tim continues to play a major role in assisting US and foreign-based manufacturers in evaluating their compliance status and in developing their auditing techniques.

As the former Quality Program Manager, Office of Compliance, CDRH, Mr. Wells managed all aspects of the deployment of quality systems including baseline evaluation (gap analysis), strategic planning, training activities, implementation activities, auditing and corrective and prevention action systems (CAPA).

An accomplished presenter and author, he has delivered over 40 presentations in the past two years for: MD&M, RAPS, IVT, Pharma Conference, IIR, Management Forum (UK), FDLI, AdvaMed, AAMI, AMDM, Irish Medical Device Association (Ireland), Biomedical Focus, FDA and numerous other organizations. Tim has been extensively interviewed by most Device and Drug publications as well as other FDA related publications.

Quarterly, we spotlight an associate who has excelled in many areas of their work. This section is dedicated to showcase these skilled and highly talented folks who have exceeded our expectations and put our customers first in all they do with QualityHub.

Congratulations to Ron Shutt (Senior Consultant & Acting Consulting Group Manager).

Ron worked for the FDA for 25 years in different locations. At the FDA he was primarly a Supervisory Investigator where he managed field investigators and associated activities. He has been a consultant since 1997. Ron's expertise lies in organizing and managing audit projects as well as assisting in the areas of total quality system (QSR) implementation and compliance. The majority of his consulting work has been in the area of medical devices and pharmaceuticals.