Event

Batch Record Review Process- 2012 Requirements

March 21, 2012 iCal

Time: 12:00-2:00pm
Location: LIVE, INTERACTIVE TRAINING WEBINAR; IN YOUR OFFICE

This live training webinar will provide valuable information on the requirements of an effective Batch Record Review process from an operational and regulatory perspective. It will interpret what the agencies mean and what they expect. It will describe how and when to implement a system that is both cost effective and compliant, in an ever-changing regulatory landscape using quality risk based methods. It will describe how to keep appropriate control over the processes and products without burdening the business. These tiered, risk based processes will allow low risk elements to be evaluated quickly and simply yet exert appropriate checks and controls on those which can have high impact on your product. It will include models of systems that will allow you to benchmark your processes to determine whether they are as robust and efficient as you believe. With the introduction of new technologies, we will examine how the Batch Review Process is changing to accommodate them. Examples of where companies failed to live up to the regulatory agency expectations will enable you to see what exactly the agencies are looking for and why.

Learning Benefits:

-What the key elements are in Batch Record Review.

-What to look for and how to remedy the issues.

-Pointers on Good Documentation Practices.

-How new technology is changing the way we review Batch records.

-How the agencies are changing their expectations of Batch Record review.

-How Quality Risk Management can be used to your advantage to focus on the really important aspects of review.

-Some useful metrics to measure your operational performance.

-How to rapidly identify degradation of operational performance and correct it before negatively impacts your bottom line.

-How companies fail to live up to regulatory and business expectations so you can avoid these pitfalls.

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