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. We will also touch on aspects of 21 CFR Part 11, the FDA’s guidance for electronic records and electronic signatures (ER/ES). There are many security aspects related to ER/ES that are key components of a sound validation and data governance program.
Objectives of the Presentation
Discuss the best practices necessary to ensure all systems are validated appropriately
Learn how to develop the appropriate computer validation strategy, to ensure a good balance of cost vs. risk
Understand how to effectively document the process of computer system validation, and maintain current information about the various systems in your organization and how they are maintained in a validated state
Learn how to develop a strategic approach to data governance to ensure data integrity, quality, identity, accessibility, and security
Why Should you Attend
After attending this course, 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, and when, under what circumstances, and, finally, using what methods.
In this webinar, we will cover the following key areas:
Establishing a data governance framework and program for data that is collected, analyzed, stored or reported using a computer system subject to FDA regulations
How to use a data governance framework as a logical structure for classifying, organizing and communicating complex activities involved in making decisions about and taking action on enterprise data
How to ensure that data governed by FDA adheres to the principles of Computer System Validation (CSV), System Development Life Cycle (SDLC) Methodology, and Electronic Records and Signatures (21 CFR Part 11), as applicable
How to leverage industry best practices in developing an overall data governance framework and program
How to ensure your data
Who will Benefit
This webinar will provide valuable assistance to all personnel in: Information Technology, Analysts, QC/QA Managers, QC/QA Analysts, Clinical Data Managers, Clinical Data Scientists, Analytical Chemists, Compliance Managers, Laboratory Managers, Automation Analysts, Manufacturing Personnel, Supply Chain Personnel, Audit Personnel, Computer System Validation Specialists, GMP Training Specialists, Business Stakeholders responsible for computer system validation planning, execution, reporting, compliance, maintenance and audit, Consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance