Effective Compliance and Regulatory Writing

Effective compliance and regulatory writing combines many disciplines, such as science, engineering, medicine, and law to create communications that advance medical, scientific, and manufacturing objectives. Documents often have multiple authors across several subject matter expert areas. This diversity frequently complicates a team’s ability to write with a consistent voice. As a rule, writing must be concise, precise, objective, and balanced. Well-designed documents should provide information in such a way the audience can understand and interpret easily. The objective of this textbook is to help authors to improve the quality of their documents. Some of the most common grammar errors and how to fix them are presented. The material in this textbook can assist personnel who write, review, or approve documents, such as standard operating procedures, work instructions, policies, validation protocols, batch records, device master records, device history files, annual product reviews, risk assessment reports, investigations, and so on. Effective writing of those documents can avoid auditors’ or other regulatory bodies’ inspection findings that could result in opening deviation investigations or any other regulatory action. The book includes the following topics: General considerations for regulatory writing Good documentation practices Developing standard operating procedures Elements of an investigation report Documentation style manuals Writing basics The material included in the textbook can be beneficial to personnel involved in developing any document for Manufacturing, Quality Assurance, Quality Control, Engineering, Regulatory Affairs, and Supplier Quality, among other areas.
ASIN: 1736742949
VSKU: BVV.1736742949.G
Condition: Good
Author/Artist:Peña-Rodríguez, Manuel E.
Binding: Paperback