Technical Writing in the Pharmaceutical Industry
Product ID : ROBP-0007
Level : Beginner
Duration : 60 Minutes
After obtaining a B.S. and an M.S. in Chemistry from Tuskegee University, Robert Peoples joined the pharmaceutical industry as a Research Chemist with a concentration in analytical chemistry at Wyeth/Lederle. While at Wyeth/Lederle Robert was primarily responsible for the analysis of the Active Pharmaceutical Ingredient (API) in various drug delivery formulations, e.g. aerosols, capsules, creams, ointments, and tablets. He joined Organon/Merck as a Research Chemist responsible for the development of stability-indicating methods of analysis using HPLC.
While at Organon/Merck, Robert transitioned into technical writing. As a Technical Writer, he was responsible for the creation of procedures for instrument qualification, test scripts, IQ/OQ/PQ protocols for sample handling, cleaning validation reports, method transfer reports, method validation reports, stability reports, Change Control and CAPAs. Later he joined Johnson and Johnson as a Technical Writer where he created stability strategies, protocols, and reports as well as SOPs developed training materials and competency profiles in addition to proofreading and improving written reports for other departments. He also edited policies and procedures, user guides, and job aids.
After leaving Johnson and Johnson Robert became a consultant to other pharmaceutical companies where he created SOPs for analytical method validation as well as pharmaceutical stability studies and stability program management. For another client company, he created stability reports that addressed FDA concerns about OOS/OOT results. For yet another client company he created stability reports, protocols and strategies for medical devices. He also created written assessments for software-controlled laboratory instrumentation.
Robert also has extensive experience in data review, stability management, and training.
Technical Writing is required by everyone at some point in their careers. All of us must document something that we have written or defended any work that we have performed. Often this documentation takes the form of Technical Documents. The principles shown in the webinar is directed to the pharmaceutical industry but apply to many disciples. Documents are created, reviewed and issued for many organizations.
This webinar will act as a starting point for personnel who are interested in improving their writing skills. It is not intended to be a detailed course in Technical Writing but is designed to introduce concerns, concepts, and ideas to assist personnel in the development of their writing skills.
Technical writing in the Pharmaceutical Industry is a highly specialized field. Technical writing differs from general correspondence in that it is written for a specific audience. Technical writing is a balancing act between being precise enough to cover the subject matter yet general enough to apply to other situations and/or projects. Technical writing often consists of SOPs and reports but may apply to any documentation written for a restricted group. Technical writing always involves reviewers
- How to begin the process
- Contributions of Technical Writing to the FDA and the Pharmaceutical Industry
- How to write the document
- Define Documentation Plans
- Illustrate parts of the Documentation Plans
- Types of Organizational Structures
- How to address comments from and negotiate with reviewers
- How to incorporate comments into the final document
- Final approval of the document
Course Level - Basic
Who Should Attend
- IT personnel
- Any highly technical
- Highly specialized personnel
Why Should You Attend
The webinar is a basic course on how to create Technical Documents in the Pharmaceutical Industry but can be applied to many industries. It functions as a guide for experienced highly technical personnel for whom writing is not their strong suit. Many people are highly skilled in their specialized fields but writing takes them out of their comfort zone. Join this webinar to gain valuable insight into creating Technical Documents with a professional appearance.