All About Data Integrity by Design

Computer system validation has been regulated by FDA for more than 40 years as it relates to systems used in the manufacturing testing and distribution of a product in the pharmaceutical biotechnology medical device or other FDA-regulated industries. The FDA requirements ensure thorough planning implementation integration testing and management of computer systems used to collect analyze and/or report data.

The program will provide you with a current snapshot of the state of industry and FDA as both forge ahead in the face of ever-changing technology. The course provides insight into the ways in which Pharma 4.0™ will serve as an enabler for next generation medicinal products and new business cases for established products. The organizational cultural and technical processes and resources are key to the success of this endeavor.

• Learn about the “12 Theses” of Pharma 4.0
• Pharma 4.0™ extends/describes the Industry 4.0 Operating Model for medicinal products
• In deference to common Industry 4.0 approaches Pharma 4.0™ embeds health regulations best practices
• Pharma 4.0™ breaks silos in organizations by building bridges between industry regulators and healthcare and all other stakeholders

Faculty Carolyn Troiano 

Midlothian Virginia United States

Carolyn Troiano has more than 40 years of experience in computer system validation and compliance in the pharmaceutical medical device tobacco and other FDA-regulated industries. She is currently an independent consultant advising companies on computer system validation and large-scale IT system implementation projects.

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