Technical Writing in a Pharmaceutical Environment
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Speaker : ROBERT PEOPLES
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When : Wednesday, May 15, 2024
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Time : 01 : 00 PM EST
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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.
Those persons who attend the webinar will understand how Technical Writing in a pharmaceutical environment differs from normal correspondence. They will learn how different Technical Writing is from novels, newspaper, and magazine articles as well as other forms of communication. The primary purpose of these forms of communication is to entertain. The primary purposes of Technical Writing are to inform (reports), instruct (Standard Operating Procedures and instruction manuals), and convince (Press Releases).
Attendees will learn how to create these types of documents and many other forms of Technical Writing. They will learn the thought processes associated with these types of Technical Documents as well as how to strengthen them and make them more valuable to the Target Audience.
People who attend the webinars will gain insight into in-house templates/outlines/procedures and their relationship to the documents created.
Attendees will also gain insight into the techniques associated with the writing processes necessary to create Technical Documents.
In addition, attendees will learn how to address comments from reviewers/approvers as well as how to gain final approval of the documents created.
Areas Covered
- How to begin the process
- How to collect information and determine what information is required
- How to identify and receive contributions from Subject Matter Experts (SMEs)
- How to write the document
- How to appreciate and address comments from reviewers/approvers
- How to negotiate when disagreements arise between reviewers/approvers
- How to incorporate comments into the final document
- How to obtain comments in accordance with required timelines
- Final approval of the document
Course Level - Basic
Who Should Attend
- Scientists
- Engineers
- IT personnel
- Statisticians
- Any highly technical, highly specialized personnel
Why Should You Attend
Scientists,
engineers, IT personnel, and statisticians among other highly technical
specialists may find writing documents in a pharmaceutical environment
to be a challenge. Join this webinar to gain valuable insight into how
to address this challenge. Learn techniques to communicate contributions
and ideas developed to stakeholders.
Topic Background
Technical Writing in a Pharmaceutical Environment differs from general correspondence in that it is written for a specific audience. It is a balancing act between being precise enough to cover the subject matter yet general enough to apply to other locations and/or projects. Technical Writing in a Pharmaceutical Environment often consists of Standard Operating Procedures (SOPs) and reports but may apply to any documentation written for a restricted group. It always includes reviewers and approvers of different expertise in the subject matter. Technical Writing in a Pharmaceutical Environment generally involves the conversion of highly technical material into language easily understood by the general public.
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$160.00
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