Computer Systems 2021 - Best Practices for Auditing a Vendor of Computer Systems Regulated by FDA

Computerized systems that are used in FDA-regulated environments (i.e., the system “touches” an FDA-regulated product, or a raw material or packaging component used in conjunction with the product during the manufacturing,
Effective and compliant computer system development, testing and validation are critical to any pharmaceutical or FDA-regulated organization. You should attend this seminar if you are responsible for planning, executing or managing a computer system that is governed by FDA regulations.
Developing a strategic approach to vendor audit
Understanding best industry audit practices to ensure FDA compliance
Identifying the key areas of vendor performance that are necessary to ensure they will meet your compliance requirements
Speaker:
Carolyn Troiano has more than 35 years of experience in computer system validation and compliance in the pharmaceutical, medical device, tobacco and other FDA-regulated industries.