Write It Down

Guidance for Preparing Effective and Compliant Documentation

af Janet Gough

This book covers writing for the FDA as it applies to the pharmaceutical industry. It presents a brief overview of the regulatory environment and documentation requirements, identifies the roles of writers and readers, and discusses the purpose of good documentation. The book offers documents and representative writing samples from throughout the industry, ranging from the laboratory to Quality Assurance to manufacturing and regulatory affairs. It provides writers with the tools they need to com... (Læs mere)