CAPA Essentials - core principles and practices needed to implement an effective and efficient CAPA process

How do you prevent becoming another FDA statistic? 88% of all Warning Letters issued in 2005 to medical device companies for Quality System / GMP deficiencies included a CAPA citation. Nearly 30% of all 483s issued that year contained a CAPA related observation. CAPA is the key to strong Quality Management System. This webinar will provide the core principles and practices needed to implement an effective and efficient CAPA process. This program is designed for the medical device, IVD, and combination product industries.

Areas Covered in the seminar:

• FDA Inspection trends related to CAPA
• CAPA data sources
• Elements of a successful CAPA system
• Integrating risk management
• Root cause investigations
• Common CAPA mistakes

Who Will Benefit:

• Quality Assurance / Quality Systems
• Compliance / Regulatory Affairs
• Operations
• CAPA Management
• Engineering
• Document Management
• Auditing

Instructor Profile:

Susan C. Reilly, Principal for Reilly & Associates, has over 20 years of quality system, quality engineering, and regulatory compliance experience in the medical device area. Her company provides practical and cost-effective quality and regulatory consulting services to ensure conformance with FDA regulations, EU requirements, Canadian requirements, and ISO Standards.

Prior to becoming an independent consultant in 1999, she was Director, Quality Systems, at Medical Device Consultants, Inc. (MDCI) and Manager, Quality Assurance at Deknatel Division, Pfizer Hospital Products Group, Inc. She was also a Quality Engineer at Burron Medical Inc.

Ms. Reilly has served as an expert witness on behalf of the Food and Drug Administration and was an active participant in the FDA/Medical Device Industry Initiative Task Force. She is a member of the Advisory Committee for the ASQ Certified Quality Auditor.

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