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
Discount : Get 15 % Discount as a early bird registrations. Use Promo code CGO15

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 )

Good Manufacturing Practices And Quality Systems.
What do the GMP's Say About Deviations & Nonconformities and CAPA Systems?
The Importance of Master Records
Classifying Deviations and Nonconformities
Analyzing the Event (Deviation or Nonconformity)
Roles & responsibilities
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, 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 in applying 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.

For any assistance contact us at support@compliance2go.com or call us at 877.782.4696

 This drug safety training will discuss the various factors to be considered and the principles of risk assessment to be followed during drug development to minimize risk.
 
Areas Covered in the Seminar:

• Risk conceptualization.
• Goals of project risk management.
• Risk management planning & safety review teams.
• Intellectual property.
• Pharmacovigilance planning in product risk management.
• Unexpected study results: efficacy, dosage, adverse events & toxicology.
• Data analysis, interpretation and presentation.
• Essentials of Data Monitoring Committees.
• Drug disposal and environmental impact.
• Labeling as a hallmark of risk management efforts.
• Post-marketing risk.

Who Will Benefit: The Webinar will present valuable risk management information and provide a familiarity with practices to mitigate risk by pharmaceutical and biotechnology personnel involved in drug development, including:

• Project managers
• Managers in drug development
• Clinical research associates
• Regulatory and safety managers
• Compliance associates

 Learn how to Use excel spreadsheet for GXP data and reduce validation cost and time. Configure Excel for audit trails, security features, and data entry verification.
 
Areas Covered in the Seminar:

• Become compliance when using Excel spreadsheets for GxP data.
• Reduce validation time and costs.
• Increase compliance while lowering resource needs.
• Avoid 483s and Warning Letters.
• Understand what validation documentation is required.
• How to use Excel’s audit trail.
• Hands on workshop to address your specific needs.
• How to use cell and file protections.

Who Will Benefit:

• Computer System users
• IT
• QA
• Managers
• Executives

http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=701688?channel=webcentral
 

Speaker: Greg Sterling, Sterling Market Intelligence and Search Engine Land
Wednesday, February 25, 2009 - 1:00 PM EST (10:00 AM PST)
As search - and searchers - becomes more sophisticated, local search continues to be a popular choice for consumers who are ready to buy. For national marketers, local search is now an important piece of any strategic marketing plan.
In this webcast, Greg Sterling will discuss the latest developments in the Local Search landscape and how successful brand marketers can - and must-take advantage of local search in their overall marketing efforts. He’ll provide an industry overview, as well as examples of what works and what doesn’t.

How did online retailers fare in the holiday selling season of 2008? The news may not be as glum as you think.

Even in today’s economy, savvy online retailers can maximize their returns, whether through investment in paid search, shopping engines or other online marketing strategies.

This webcast looks at online retail lessons learned during the 2008 holiday shopping season, and how to apply those learnings to your 2009 strategy.

We’ll get a postmortem from comScore about just how retail markets did in the current economic climate. Which segments performed better than others - and why?

We’ll also get a report from the trenches: Vintage Tub and Bath, a Top-500 Internet Retailer, will share some of its online marketing tactics - from pushing product reviews, to fine tuning paid search and effectively using shopping comparison engines.

Chris Wine of Marin Software will give some concrete tips on how to factor seasonal and economic fluctuations into your online marketing campaign using Marin Search Marketer.

Attend this webcast and learn:

* How 2008 online retail sales compared to 2007
* Which SEM tactics were successful - and which weren’t
* How to improve your 2009 retail PPC strategy with Marin Software’s application
* When to cut back - or ramp up - your marketing budget
* How to take advantage of day of week and seasonality data

…and more