Course Description

Writing Effective Regulatory, Medical and Technical Documents

April 4-6, 2022 | Time 9:00am - 1:30pm EDT / 15:00-19:30 CEST
Virtual Course

Course Offering 220404VT0162
Course ID 162

In-Person Course

Who Should Attend?
This course will benefit professionals from new hires to managers in the pharmaceutical, medical device, biologics and related health industries who would like to write more effective documents. It is a valuable course for those in:
- Clinical Research
- Product Development
- Regulatory
- QA/QC
- Compliance
- Manufacturing
- Engineers/Scientists
- Directors and Managers
- New Hires

Individuals who assess the readiness of documents for submission would also benefit from this course to better provide feedback to authors on needed revisions.

Course Description
The approval of a drug product or medical device regulatory submission hinges in large part on the quality of the documents submitted to regulatory authorities. Thus, writing accurate, concise, well-referenced and clear technical documents is critical for a company’s business success. Effective writing is a skill that must be constantly refined to produce these quality documents.

This practical 12-hour accredited course will teach you methods to evaluate your writing style and apply steps to express complex ideas more clearly and concisely. Through lectures and class exercises you will learn strategies for organizing, writing, editing, and proofing documents and correspondences. Essential elements of technical report sections will also be discussed, as well as how to write effective summaries and respond to FDA requests for information.

Live Virtual Attendees:
Since these workshops are highly interactive, you must have a webcam on your computer equipped with a microphone and speakers/headset in order to participate.

Past Attendees have said..."
“This course was excellent. I really liked the way things were presented. Zeinab was communicative, knowledgeable and very attentive.” - M.M., Contract Pharmaceuticals Limited Canada

Course Director
Zeinab Schwen, President, Strategic Regulatory Consulting

Zeinab Schwen is an experienced technical expert, writer, lecturer, and entrepreneur with over 39 years in the pharmaceutical and medical device industries. While working for major pharmaceutical companies, Ms. Schwen gained hands-on experience in drug metabolism, drug development, and clinical trial management. She monitored large multicenter trials and participated in writing and preparing large drug submissions for several Rx therapeutic categories. Ms. Schwen later founded a successful consulting and medical communications company that has been supporting the pharmaceutical, medical device, biologics, and the healthcare industry for over 27 years. In her capacity as the President of Strategic Regulatory Consulting, Ms. Schwen has provided product development, regulatory consulting, submission assistance, and medical communications services to companies nationwide.

As a successful lecturer, Ms. Schwen has taught at several Universities and has led numerous regional and international workshops on medical, technical, and regulatory writing. Ms. Schwen has also served on the boards of numerous non-profit organizations focused on women’s self-sufficiency, poverty, and other cultural and social justice issues.

Venue Information
Your Computer