Leading Practices on Compliance Series: Verifying and Validating CAPAs
AAMI's leading practices documents provide practical guidance to medical technology professionals on a wide range of specific topics. Each document briefly examines a specific challenge or topical issue and then offers specific solutions through the use of case studies; bulleted tips from experts; and easy-to-use forms, checklists, and other tools. Peer-reviewed, leading practices are designed to be quick reference documents addressing important topical issues.
This series of leading practices provides practical guidance to medical device manufacturers on historically problematic areas of compliance with FDA’s Quality System regulation. Each document serves as an easy reference tool and spells out the requirement, provides supplemental information on the intent of the requirement, and offers real-world suggestions for how to comply with the requirement.
In coordination with the launch of the leading practices series, AAMI is offering a series of webinars on each of the documents. The speakers are individuals who have years of experience in the medical device regulatory environment and are active within the AAMI community, either as faculty for quality systems or standards-related training or members on standards committees.
The first webinar in the series, “Verifying and Validating CAPAs,” addresses a topic which is one of the most frequent causes of FDA 483 observations for medical device firms. Within the corrective and preventive action section of the Quality System Regulation (21 CFF 820.100) is a requirement to verify or validate corrective and preventive action, and this requirement is coupled with the need to insure that all activities are documented.
This webinar and its corresponding guidance document provides some assistance to medical device firms in understanding and implementing these sections of the regulation.
For more information on how to obtain the Leading Practices document, click here.
PROGRAM-AT-A-GLANCE
| WHO SHOULD PURCHASE |
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| Instruction is targeted to quality assurance, quality system compliance and regulatory affairs professionals; personnel responsible for the implementation of CAPA systems; and CAPA system management. | |
| QUESTIONS? | |
For questions about ordering the CD, please contact AAMI publications at 1-877-249-8226 or 240-646-7031. |
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| RELATED PUBLICATION | |
| CAPA Verification and Validation: Practical Approaches to Compliance |
Over the course of one hour, the program addresses several challenges associated with the CAPA verification/validation activity:
- When should the verification/validation be performed?
- How to simply but effectively document the verification/validation activity?
- Are there differences between the expectations of FDA and the auditors for the ISO 13485 standard in the area?
- What is meant by the regulation term, “to ensure the action is effective and does not adversely affect the finished device?”
Each of these issues requires an understanding of the FDA’s expectations to preclude having this topic result in a 483 observation. This webinar briefly reviews these challenges and provides some tools and concepts for solving these concerns.
SPEAKER
- Arthur J. Ward, PhD, Medical Device Consultant, AJW Technology Consultants Inc.
WEBINAR CD
Includes pdf of handout materials and webinar recording on CD. Please note that the CD will be available three weeks after the program.
- $50 for webinar registrants
- $75 for non-registrants
- domestic and international shipping rates apply
WAYS TO PURCHASE
- Online - Buy now.
- Phone - 1-877-249-8226 or 240-646-7031 to order with a credit card.
- Fax - Select and download the order form and fax to 240-396-5781.
- Mail - Select and download the order form and mail with payment to:
AAMI Webinar CD Package
Leading Practices: Verifying and Validating CAPAs
PO Box 0211
Annapolis Junction, MD 20701-0211