CAPA and the related actions of Failure Investigation and Root Cause Analysis (RCA) is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities.
A compliant CAPA system is required to to "close-the-loop" complaints, non-conformances, out-of specification conditions, and must also include proper impact analysis / actions. As such CAPA is a major element of cGMP compliance (one of the four key inputs of QSIT, the FDA's Quality Systems Inspection Technique), and is also a key source of regulatory problems.
How can companies allocate scarce resources to those activities that have the greatest impact to product quality / safety, minimize resources on minor issues, and still satisfy the regulatory agencies? Use the proper Failure Investigation, Root Cause Analysis methodologies, not just to satisfy regulatory requirements, but to facilitate a closed-loop problem resolution system to reduce "fire fighting" and minimize costly product quality problems.
Why you should Attend: Expectations for meaningful, results driven CAPA (Corrective and Preventive Action) System that addresses and resolves underlying product problems are increasing among regulatory agencies world wide, with good reason.
Design Control (CGMPs and ISO), EU’s MDD / MDR, ISO 14971 (Device Risk Management) and the FDA’s QSIT and Q9, underscore this increased emphasis. A valid closed-loop CAPA system utilizes root cause analysis for true problem (not symptom) resolution.
Growing high-profile field problems indicate that effective, "closed loop" CAPA is still not the industry norm. The billions of dollars spent by industry annually on quality / GMP are not providing the product safety or efficacy seemingly promised. And for most companies, the fixes are not rocket-science, but proper up-front risk-based, closed-loop CAPA, an intregral part of viable Quality Management / cGMP planning, implementation and execution systems.
Areas Covered in the Session:
Regulatory "Hot Buttons"
Correction, Corrective Action, Preventive Action Defined
Impact Analysis and Response - a Key Component
Failure Investigation and Assessment
Root Cause Analysis - Approaches and Tools
Data Sources / Metrics
Verify and Monitor for Effectiveness
"Bullet Proof" / "Closed-Loop" Lock In the Change
Beyond Regulatory Compliance
Who Will Benefit:Senior management in Drugs, Devices, Biologics, Dietary
Consultants; others tasked with product, process, CAPA resolution, failure investigation / root cause analysis responsibilities
John E. Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, U.S. FDA responses. In addition, he has successfully designed, written and run all types of process, equipment and software qualifications/validations, which have passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide.