This book covers writing for the FDA and other regulators as it applies to the therapeutic product 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 the industry, ranging from the the laboratory to Quality Assurance to manufacturing and regulatory affairs. It provides writers with the tools they need to complete writing tasks effectively.
This book covers writing for the FDA and other regulators as it applies to the therapeutic product 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 the industry, ranging from the the laboratory to Quality Assurance to manufacturing and regulatory affairs. It provides writers with the tools they need to complete writing tasks effectively.
Writing Within the Regulated Environment. Connecting Writer and Reader. Organizing and Delivering Information. Correspondence. Policies Plans Manuals Procedures Methods and Instructions. Routine Reporting. Process Reports. Summary Reports. Developing a Clear Style. Building Strong Sentences. Managing Verbs in English. Punctuating Effectively. Working on Words. Acronyms Symbols and Abbreviations. References.
Writing Within the Regulated Environment. Connecting Writer and Reader. Organizing and Delivering Information. Correspondence. Policies Plans Manuals Procedures Methods and Instructions. Routine Reporting. Process Reports. Summary Reports. Developing a Clear Style. Building Strong Sentences. Managing Verbs in English. Punctuating Effectively. Working on Words. Acronyms Symbols and Abbreviations. References.
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