Effective and compliant computer system data management is critical to organizations in the pharmaceutical, biologics, vaccines, tobacco, animal health, medical device, or other FDA-regulated industry. During the past 30 years, best practices have been developed to ensure computer systems used in these environments can be cost-effectively managed while meeting all aspects of FDA compliance. To take this a step further, we are now looking at ways to ensure the data that resides on these systems is also managed in a compliant manner and one that will provide the best results for operations at the lowest cost.
Upon completion of this session, attendees will have an understanding of how to:
After attending this webinar, you will understand data governance as a quality control discipline for assessing, managing, using, improving, monitoring, maintaining, and protecting organizational information. It is a system of decision rights and accountabilities for information-related processes, executed according to agreed-upon models which describe who can take what actions with what information, when, under what circumstances, and, finally, using what methods.
Why Should You Attend:-
Upon completion of this session, attendees will have an understanding of how to effectively and efficiently manage data through a governance program that spans their organization. The attendees will also gain a thorough understanding of data integrity and the FDA’s concern with this area that is trending in terms of citations during the inspection. You will learn about how to assure data integrity requirements are met, including validation, testing, and other means of providing technical and/or procedural controls to mitigate any potential risk.
The attendees will have a good grasp of how to leverage the best practices across all systems by creating a standardized program for data governance. We will cover industry best practices and discuss ways to avoid the pitfalls of failing to secure and maintain data integrity.
Who Should Attend:-
Vendors and consultants working in the life sciences industry who are involved in computer system implementation, validation, and compliance
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