Avoiding an FDA Warning Letter with a Strong CAPA Program

Mark Perkins
Instructor Mark Perkins
Product Id 600674
Duration 90 Minutes
Version Recorded
Original Price $295
Special Offer Price $10
Refund Policy
Access recorded version only for one participant; unlimited viewing for 6 months

Avoiding an FDA Warning Letter with a Strong CAPA Program

The development and implementation of an effective CAPA system is not well understood by many device companies. This webinar is designed to clarify what the FDA is looking for in the CAPA system. Examples of warning letters will be reviewed to understand common themes found by FDA.

Part of the problem is differences in terminology between the QSR and ISO 13485.  This leads to confusion at times with the various team members involved in CAPA resolution. The differences in terminology will be clarified and an approach towards how to reconcile these within your system will be covered during this webinar.

The webinar will also address what to include within the CAPA system, how to appropriately document CAPA responses, reviews and approvals. Also timelines and escalation process will be covered as well.

Why should you attend: CAPA is a major subsystem of the FDA’s Quality System Regulation (QSR) and is always included in any QSIT inspection.  Deficiencies in the CAPA system are consistently the top area of FDA 483 observations.

A study of the FDA's EIR Turbo Database conducted for all 2010 data identified 1058 observations related to CAPA, making it number one on the list of overall observations.

Too often medical device companies fail to implement an effective CAPA program and find themselves in the unfortunate position of responding to FDA warning letters, along with subsequent additional FDA oversight which are a matter of public record.

Beyond FDA, ISO 13485 Registrars also place a high degree of focus on the CAPA system during their certification and surveillance audits.

Areas Covered in the Session:

  • Understand FDA's most common findings related to CAPA Review samples of warning letters published by FDA for deficiencies in the CAPA system
  • Review and reconcile differences in FDA’s QSR and ISO 13485 CAPA terminology
  • Review examples of nonconformities and how they should be addressed in the CAPA system (Correction, Corrective Action, Preventive Action determination)
  • Overview of how to define and document CAPA in the Quality System, including what needs to be included in the various stages of CAPA response, review and approval
  • Address Ownership, Timelines and Escalation of CAPAs
Who Will Benefit:
  • Regulatory Affairs professionals
  • Quality Managers
  • Quality Engineers
  • Consultants
  • Quality System Auditors
  • Manufacturing Managers
  • Manufacturing Engineers
  • Design Managers
  • Design Engineers
  • Purchasing Managers
  • Buyers
Speaker Profile
Mark Perkins began his career in Aerospace in 1983 and transitioned into Medical Device QA/RA in 1998. He held management positions in QA/RA in Class I, II and III device companies from 1998 to 2008. He established a consulting practice, working with various medical device companies between 2008 and 2010, prior to recruitment to AMS in San Jose, as the Director of Quality from 2010 through 2011, Mark has recently relocated to the San Diego area, and is currently consulting.

Mark is a registered Professional Engineer in the state of California, is RAC (US) certified through RAPS, and is ASQ Certified (CQE, CQM, CQA). Mark received his BS in Industrial Engineering from Texas A&M in 1983, and his Advanced Certificate in Regulatory Affairs from San Diego State University in 2006.

Mark has been active with RAPS, serving as the Registration Manager and then Device Programs Manager with the SF chapter from 2009 to 2011. He also has been active with Silicon Valley ASQ (RAPS Liaison) and the ASQ Biomedical Division Northern California Discussion Group.

Mark has presented on CAPA, Complaints, Corrections and Removals at both RAPS and ASQ sponsored events and other venues.

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