Good Documentation Practices to Support FDA Computer System Validation
OVERVIEW FDA requires that all documentation related to GxP products (GMP, GLC, GCP) be created and maintained in accordance with specific rules. From the color of the ink used to the retention requirements, you’ll learn all about how to create and maintain good FDA-compliant documentation. The webinar will leave you with the information needed to create and maintain good documentation that meets FDA compliance standards. You will learn about what must be done and what must not be done. In addition, you’ll learn about the various computer system validation guidelines, deliverables and how to document them. WHY SHOULD YOU ATTEND You should attend this webinar if you are responsible for any FDA-regulated data and/or records. All documents need to be created and maintained in accordance with FDA guidelines for good documentation to avoid any issues during an inspection or audit. You will also benefit from learning about the computer system validation guidelines...