Synopsis
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.
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About the Author
Manuel E. Peña Rodríguez is a process improvement and training consultant with more than 25 years of experience in many industry sectors. Since January 2006, he is fully devoted to consulting under Business Excellence Consulting Inc. He also served as professor in the graduate program in biochemistry at the University of Puerto Rico, Medical Sciences Campus, in San Juan PR. Mr. Peña Rodríguez received his Juris Doctor degree from the Pontifical Catholic University of Puerto Rico and his Master of Engineering in Engineering Management degree from Cornell University in Ithaca NY. He is also a licensed Professional Engineer registered in Puerto Rico and an attorney registered in the Supreme Court of Puerto Rico and the U.S. District Court for the District of Puerto Rico. Mr. Peña Rodríguez is an ASQ Certified Six Sigma Black Belt, Manager of Quality & Organizational Excellence, Quality Engineer, Quality Auditor, Medical Device Auditor, and Food Safety & Quality Auditor. He is also a Senior member of ASQ and former Chair of the Puerto Rico ASQ Section. He is the author of the books "Statistical Process Control for the FDA- Regulated Industry" and "Process Monitoring and Improvement Handbook", published by ASQ Quality Press. His most recent textbooks are "Effective Internal Auditing" and "Effective Compliance and Regulatory Writing", published by BEC Press. Mr. Peña Rodríguez is also the author of the article "Serious About Samples: Understanding Different Approaches for Process Monitoring and When to Use Them" and co-author (with José Rodríguez-Pérez) of the articles "Fail- Safe FMEA", "CAPA Pitfalls and Pratfalls", and "Essential Evaluation". All those articles were published in the monthly editions of the ASQ Quality Progress magazine.
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Effective Compliance and Regulatory Writing
Published by
BUSINESS EXCELLENCE CONSULTING, 2022
ISBN 10: 1736742949
ISBN 13: 9781736742945
Used
Softcover
Seller: Blue Vase Books, Interlochen, MI, U.S.A.
Seller rating 5 out of 5 stars
Condition: good. The item shows wear from consistent use, but it remains in good condition and works perfectly. All pages and cover are intact including the dust cover, if applicable . Spine may show signs of wear. Pages may include limited notes and highlighting. May NOT include discs, access code or other supplemental materials. Seller Inventory # BVV.1736742949.G