2011 - 2011 webinar on Applying GMP Quality Principles To Control Nonconforming Products/Deviations is and Implement an Effective Corrective And Preventive Action Program

Summary
Corrective & Preventive Action (CAPA) systems have been in existence since the dawn of time. When a negative event occurs, one of the first questions is how and why did it happen? Depending on the impact of the event, there is an analysis or investigation of the event to determine all aspects of the 'Why' and the 'How'. Although quite informal, this is a rudimentary CAPA system.
Details

Tuesday, September 13, 2011,DURATION : 01:00 to 02:30 PM EST

FREE HANDOUTS:
"Attendees will receive Reduced Testing of Materials for Pharmaceuticals & Medical Devices"

Details
Sometimes, no matter how well controlled, the input of the process fails to produce the expected output. A deviation or nonconformance has occurred. A deviation is defined as a departure from the expected input, in other words, a procedure was not followed, or a specification requirement was not met. A nonconformance, according to Part 820, means the non-fulfillment of a specified requirement. This requirement, like that of a deviation, indicates a procedure was not followed or a specification requirement was not met. When deviations/nonconformities occur, a system must be in place for evaluating the impact on quality, conducting an investigation to determine root cause, and following up to verify the root cause was properly identified .A Corrective and Preventative Action(CAPA) system must be in place to track these events until closeout of the event is completed.
Medical product problems require a stringent and formal CAPA system. The original GMP regulations for devices & drugs were embedded within the regulations. CAPA systems were first formalized for devices in the 'Quality Systems Regulation' and for drugs in ICH Q-10, 'Pharmaceutical Quality Systems'
The principles of handling deviations and nonconformities are the same for devices and drugs. For devices, the process is well outlined in the regulations. However, for drugs, the requirements are not so defined.

Why should you attend : The FDA establishment inspection focuses on nonconformities/deviations and CAPA systems because deviations and nonconformities point toward quality system failures. You and your firm must be prepared. However, the need for a CAPA system is much more than a compliance requirement. Combined with investigations, it is one of the most useful tools for analyzing data leading to quality improvements and efficiencies.
This webinar will explore the Event-Investigation-CAPA (EIC) lifecycle and how you can apply it to your operations. This EIC lifecycle will be explained using graphics to explain regulatory requirements and industry practice, These graphics will serve as a model for establishing an effective and practical CAPA system.
By attending this webinar, you will better understand CAPA systems, learn ways to better use or improve your existing system, and begin development and implementation of a new CAPA system.

Areas Covered in the Session (Objectives & Overview )
1. Good Manufacturing Practices And Quality Systems.
2. What do the GMP's Say About Deviations & Nonconformities and CAPA Systems?
3. The Importance of Master Records
4. Classifying Deviations and Nonconformities
5. Analyzing the Event (Deviation or Nonconformity)
6. Roles & responsibilities
7. The Deviation-Nonconformity and CAPA Lifecycle
? Event
? Discovery
? Immediate Actions.
? Notification of Event.
? Establishing the Investigative Team (What function should take the lead?)
? Data Collection.
? Establishing the Root Cause
? Preparing the Report and Conclusion
? Approval of the Report
? Close-Out & CAPA Entry
? Tracking & Follow-Up.
? Determining the Effectiveness.
? The Next Step
8. Documentation and Record Keeping
9. What Will the Computer Do for You?
10. Review

Who will benefit :
? Quality Control
? Laboratory Manager
? Warehousing
? Purchasing
? Managers and Procurement Managers,
? Laboratory Analyst,
? Cost Accounting,
? IT Documentation Management

Instructor Profile : Howard enjoys sharing his 30 years plus experience in starting up, developing, implementing, managing, and remediating pharmaceutical and medical device quality systems. He derives considerable satisfaction from diagnosing quality systems in order to make them more compliant, efficient, Â Â Â and productive. He has a BS in Biology/Chemistry and Political Science as well as work toward an MBA. His ability to quickly learn the technology is demonstrated by his success inapplying quality assurance principles to a wide range of pharmaceuticals and medical devices. He is a Certified Biomedical Auditor (CBA), Certified Quality Manager (CQM), and Quality Auditor (CQA). His technical education is further complemented by his Political Science degree helping him understand the regulatory process; his work toward an MBA provides business insight. He is a member of ASQ, PDA, AAMI, RAPS, and SQA. He strongly believes that Quality is very influential in shaping successful operations. He knows how to use his leadership abilities to build organizational relationships that make systems operate effectively as well as to develop and empower people.
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