Supply Chain Issues (21 CFR Part 820.50 and 820.80) and Warning Letters

The FDA Investigators are increasingly looking at the processes used by firms to qualify their suppliers, auditing levels applied to suppliers and service providers, the incoming inspection of the components, and the level of scrutiny of these controls, based on the risk assessment of these.

This presentation will review the regulatory requirements for the Medical Device Quality System Regulations, guidance documents and a review of the citations, which the Agency has written to firms in their Warning Letters. This presentation will provide a better understanding of what the FDA expectations are for Purchasing Controls, how to better document your firm’s activities and control components and services at the earliest points vs. when it fails on the line or in distribution.

This presentation is primarily directed to medical device quality personnel and other staff who are selecting, auditing and receiving purchased components and services (design control, quality, purchasing, and internal auditors). Also, those who receive customer owned products for servicing.

Areas Covered in the Session :

• FDA Quality System requirements
• Guidance document review, if any
• Review of Warning Letter citations
• What to do:
  • Auditing activities (visits vs. surveys)
  • Sampling plans/ship to stock/etc.
  • Documentation of procedural controls/activities to demonstrate compliance
• Interactive Q&A Session

Who Should Attend:

• Quality Departments
• Regulatory Affairs Departments
• Research & Development Departments
• Production Departments
• Quality Engineers
• Product Marketing Departments
• Every professional involved with selecting and qualifying suppliers for a new device design

Course Director: RICK RUTHERFORD

Rick Rutherford served as an FDA Investigator for twenty-four years and was a device and biologic certified level II investigator (one of only a handful of investigators Agency wide certified at Level II in more than one program). He served as a Performance Auditor/Trainer for the Agency’s Level II internal certification of investigators and for the Accredited Persons third-party program. He was a device expert for the last several years and served in the International Inspection Cadre. His experience includes greater than 120 international medical device inspections. Since retiring from the US Public Health Service Commissioned Corps and the US Food and Drug Administration, Rick has been active, as a consultant to medical device firms in the US and internationally, performing mock FDA audits, providing training, webinars and consultation on remediation following FDA 483 citations, Warning Letters and consent decrees issued by the FDA. He has a B.S. in Biology and has been trained in 36 training courses in the full range of FDA regulatory coverage. His experience also includes being a US Navy Hospital Corpsman with hands-on patient care, environmental health issues and has worked in the Oklahoma State Department of Health.