Quality System Inspection Technique (QSIT) :FDA

June 18, 2009

According to the FDA, 30% of the 10 most frequent observations in Form 483s issued for QSIT inspections are related to CAPA, and 50%  are CAPA-related for non-QSIT inspections.

See webinars which can help device makers to ensure quality standards

  1. CAPA – The Heart of Your Quality System
  2. CAPA systems in Post Marketing Surveillance
  3. Root Cause Analysis for CAPA Management (Shutting Down the Alligator Farm
  4. How CAPA and complaint handling should interact in Medical Device – Simplification of the processes is often needed to preserve their effectiveness
  5. Preparation of a corrective action/preventive action plan (CAPA) in Drug Safety/Pharmacovigilanc

Upcoming Medical Device webinars

August 12, 2008

I found a website where good number of webinars are available across Medical Device, Pharma, HR, Healthcare, right now I am listing medical device related webinars here but for further areas please refer ComplianceOnline.

  1. Process Mapping – Risk-Based P&PC
  2. Bullet-Proof CAPA
  3. Management Controls Under QSR and ISO 13485
  4. Introduction to Process Capability (Cp, CpK, Pp, Ppk)
  5. Successful 510(k) Submissions
  6. Designing an Effective Cleaning and Disinfection Program for Pharmaceutical, Biotech, and Medical Device Cleanrooms
  7. The Gateway: A Risk-Based Filter for Effective CAPA Management
  8. Design and Process FMEA Concepts
  9. Using HACCP Quality Plans to Improve Medical Device Compliance Outcomes
  10. Basic Requirements for Steam Sterilizer Validation per ISO 17665
  11. The Rapidly Emerging Field of FDA Safety Science:Its Impact on Regulatory Affairs, Quality Systems and Company Profitability
  12. Internal Auditor Training for ISO 13485 Auditors
  13. Understanding ISO 13485 vs. ISO 9001 for Successful QMS in Medical Device Industries
  14. Preparing for a U.S. FDA Audit
  15. Regulatory Requirements for Personnel Training to Assure QSR and ISO Compliance
  16. Managing Risk at the R&D–Manufacturing Interface
  17. The Road to FDA Approval: Advisory Committee Survival Strategies

FDA and CAPA

July 18, 2008

The FDA issued 74 good manufacturing practice (GMP)-related warning letters to device firms last year, 84 percent of which contained citations for Corrective Action Preventive Action (CAPA) system deficiencies.

FDA Focusing:

  1. On CAPA system deficiencies
  2. On right to review all CAPAs even when companies begin them as a result of internal audits

Why CAPA

CAPA management is integral to meet the FDA’s expectations and its GMP regulations. More than just a regulatory requirement, effective CAPA management also is a good business practice that can reduce company liability and warranty claims and increase customer satisfaction.

SOLUTION

Effective CAPA systems reduce regulatory risk by managing and streamlining the quality-reporting process.

Advantage:

  1. Reduces bad inventory
  2. Generates fewer regulatory warnings and recalls, and
  3. Increasing company profits and customer satisfaction

More here>>