Carolyn Troiano has more than 40 years of experience in Computer System Validation (CSV) and compliance in the pharmaceu...
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Description
So what is next for the modernization of the processes involved in compliance for FDA-regulated systems, keeping in mind the guidance documents provide thus far?
The FDA is embarking on a modernization program to update their technology and processes for working with industry to assure regulated products meet FDA compliance. There are numerous programs underway, including partnerships with other agencies and industry to move forward as technology continues to improve.
The FDA plans to take advantage of these technologies, just as industry is focused on the same goal. The key is making sure these are employed in a way that promotes public health, providing more improved FDA-regulated products with fewer negative side effects and issues. Plans will also enable FDA to work with industry to move products to market faster, further improving public health.
Pharma 4.0 provides an operating model for FDA-regulated products. It embeds health regulations best practices in the model.
We will explore the best practices and strategic approach for evaluating the current processes involved in assuring computer systems used in the conduct FDA-regulated activities are modernized and streamlined. Cloud computing, automated computer system testing and mobile devices are just part of the mix we can expect to explode in the near term.
Finally, we will provide an overview of industry best practices, with a focus on data integrity and risk assessment that can be leveraged to assist in all your GxP work.
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$999
Unlimited live sessions
THE SUBSCRIPTION IS VALID FOR A YEAR
$499
Unlimited live sessions
THE SUBSCRIPTION IS VALID FOR 6 MONTHS
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Margie Faulk
Margie Faulk is a senior-level human resources professi...
Garrett Wasny , MA, CMC, CITP/FIBP
GARRETT WASNY, MA, CMC, CITP/FITP, is a Certified Manag...
Lynn Anderanin
Lynn Anderanin, CPC,CPC-I, COSC is the Sr. Director Cod...
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