Leading Practice on Compliance Series: Corrective and Preventive Action (CAPA) - System Implementation and Compliance
The seventh webinar in the series addresses an area that continues to be one of the leading deficiencies cited in warning letters issued by the FDA since the Quality System Regulation came into effect in 1997. Corrective and Preventive Action (21 CFR 820.100) addresses the following requirements: identify nonconforming product and other quality problems, investigate cause, implement corrective and preventive action, verify and validate actions and effectiveness, communicate information on the problems and necessary actions, and forward information to management review.
This webinar and its corresponding Leading Practices publication provides examples on key points for implementing an effective CAPA system in compliance with the Quality System regulation.
| WHO SHOULD PURCHASE |
|
| Instruction is targeted to quality managers, quality auditors, quality assurance professionals, regulatory/ compliance professionals, and executive management. |
|
| QUESTIONS? | |
For questions about ordering the CD, please contact AAMI publications at 1-877-249-8226 or 240-646-7031. |
|
PROGRAM OBJECTIVES
Over the course of one hour, the program will address the FDA concerns and industry best practices associated with CAPA:
- Development of standard operating procedures
- Analysis of data
- Investigations and actions taken
- Feedback mechanism for the CAPA system
- Closed loop for the quality system
SPEAKER
- Christine Driscoll, Director Regulatory Affairs, New York Blood Center, New York, NY
WEBINAR CD
- Time: 1 hr
- 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 Practices on Compliance Series: CAPA: System Implementation and Compliance
PO Box 0211
Annapolis Junction, MD 20701-0211

