Designed and built with care, filled with creative elements

Data Governance for Computer Systems Regulated by FDA

  • No products in the cart.
a
  /  FDA Regulatory Compliance  /  Data Governance for Computer Systems Regulated by FDA

Data Governance for Computer Systems Regulated by FDA

$99

About this course

Watch RECORDED Session for Just $99

Recorded On: December 18, 2018

Training Duration: 60 Minutes

Access any day, anytime, unlimited times as per your convenience*


OVERVIEW :

Effective and compliant computer system data management is critical to organisations in the pharmaceutical, biologic, 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.

 

 

Areas Covered in the Session:

 

This webinar 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 integrity is maintained

 

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 organisational information. It is a system of decision rights and account abilities 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.

 


Who will benefit :

Within FDA-regulated companies, people in the following roles will benefit from this presentation:

  • Information Technology Analysts
  • Information Technology Developers and Testers
  • QC/QA Managers and Analysts
  • Analytical Chemists
  • Laboratory Managers
  • Automation Analysts
  • Computer System Validation Specialists
  • GMP Training Specialists
  • Business Stakeholders/Subject Matter Experts
  • Business System/Application Testers
  • Clinical Data Managers and Scientists
  • Quality Managers, Chemists and Microbiologists
  • Regulatory Affairs Personnel
  • Consultants in the Life Sciences and Tobacco Industries
  • Interns working at the companies listed above

 

*Anyone who is involved in the development, testing, manufacturing, storage, handling and distribution of product must understand and conform to FDA requirements for data quality and integrity. Finally, anyone who is acting as a consultant or contractor to a company in an FDA-regulated industry should attend to ensure they are able to bring the most current knowledge and expertise to their assignment.

 

 

In this Recorded Sessionyou can listen to Q&A which includes direct answer from our expert speaker.

*Instruction kit to access the session will be emailed within 6 hours.

 

Reviews

0
0 Ratings

5 Stars

0

4 Stars

0

3 Stars

0

2 Stars

0

1 Stars

0

User registration

Reset password