ComplianceOnline

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

Instructor: Susan C Reilly
Product ID: 700299
Training Level: Advanced
  • Duration: 60 Min

recorded version

$149.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Apr-2007

Training CD / USB Drive

$250.00
One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-362-2367

Email: customercare@complianceonline.com

Read Frequently Asked Questions

This program is designed for the medical device, IVD, and combination product industries

Description

This webinar will provide the 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.

Follow us :
Upcoming In-person Seminars by EX-FDA OFFICIALS
FDA's Regulation of Regenerative Medicine including Stem Cell Treatments

Refund Policy

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.

If you have any concern about the content of the webinar and not satisfied 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 customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

Product Reviews

This product hasn't received any reviews yet. Be the first to review this product! Write review

Best Sellers
You Recently Viewed
    Loading