Leading Practice on Compliance Series: Corrective and Preventive Action (CAPA) - Controlling Nonconforming Product
The eighth webinar in this series addresses an integral part of the Corrective and Preventive Action (CAPA) process, nonconforming product (21 CFR 820.90). The phases for addressing the requirement for nonconforming product include the identification, documentation, evaluation, segregation, and disposition of the product. Corrections can be taken to eliminate the detected nonconformance, but there are times when no actions are needed. In these situations good objective evidence and documented justification is required.
This webinar and its corresponding Leading Practices publication help you decide when an event can simply be monitored and trended, or when there is a need for an investigation.
| WHO SHOULD PURCHASE |
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| Instruction is targeted to quality managers, quality auditors, quality assurance professionals, regulatory/ compliance professionals, and executive management. |
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| QUESTIONS? | |
For questions about ordering the CD, please contact AAMI publications at 1-877-249-8226 or 240-646-7031. |
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PROGRAM OBJECTIVES
Over the course of one hour, the program will address the FDA concerns and industry best practices associated with nonconforming products:
- Responsibility for nonconforming product
- Actions that can be taken to eliminate the nonconformance
- Internal and external impact of the nonconforming product
- Linking nonconforming product to the CAPA system
SPEAKER
Christine Driscoll, Director Regulatory Affairs, New York Blood Center, New York, NY
WEBINAR CD
- Time: one hour
- Includes pdf of handout materials and webinar recording on CD.
- $50 for webinar registrants
- $75 for non-registrants
- domestic and international shipping rates apply
WAYS TO PURCHASE
- Online - Buy online.
- 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
Leading Practice in Compliance Series: CAPA, Controlling Nonconforming Product
PO Box 0211
Annapolis Junction, MD 20701-0211

