Overview:
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"
- CAPA Background
- 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
- Supplements
- QA
- RA
- R&D
- Engineering
- Production
- Operations
- Consultants; others tasked with product, process, CAPA resolution, failure investigation / root cause analysis responsibilities