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

Speaker

Instructor: Susan C Reilly
Product ID: 700299
Training Level: Advanced

Location
  • Duration: 60 Min
This program is designed for the medical device, IVD, and combination product industries This webinar will provide the core principles and practices needed to implement an effective and efficient CAPA process
RECORDED TRAINING
Last Recorded Date: Apr-2007

 

$149.00
1 Person Unlimited viewing for 6 month info Recorded Link and Ref. material will be available in My CO Section
(For multiple locations contact Customer Care)

$250.00
Downloadable file is for usage in one location only. info Downloadable link along with the materials will be emailed within 2 business days
(For multiple locations contact Customer Care)

 

 

Customer Care

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Read Frequently Asked Questions

 

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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Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).

 

 

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