FDA Validation 2011 - Change Control Under the cGMPs and How the Regulations are Changing

This webinar on change control will discuss how to interpret the cGMP regulations with respect to the present climate of requirements and will look into the future to assure that the system you implement will be acceptable to the regulators and your business requirements in the future.

This webinar will provide valuable information on the requirements of an effective change control process from an operational and regulatory perspective. It will describe how and when to implement a system that is both cost effective and compliant, in an ever-changing regulatory landscape, keeping appropriate control over the processes and products without burdening the business.

These tiered, risk based processes, discusses in this training, will allow low risk changes to be implemented quickly and simply yet exert appropriate checks and controls on those which can have high impact on your operational success and your regulatory standing. These tiered systems allow you to rapidly change your strategy when regulatory requirements change. We 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. Examples of where companies failed to live up to the regulatory agency expectations will be presented that enable you to see what exactly the agencies are looking for and why.