Effective and Compliant Technical Writing
Joy McElroy entered the pharmaceutical industry in 1992 shortly after earning a Bachelor of Science degree at North Carolina State University. She began at Pharmacia & UpJohn performing environmental monitoring and sterility testing. From there she moved into a supervisory role at Abbott Laboratories where she oversaw the quality control lab. In 1998, Ms. McElroy moved to Wyeth Lederle and worked in quality assurance, performing GMP compliance audits, batch record reviews, and holding annual GMP training for new employees. After working in quality assurance for a few years, she moved into equipment qualification and cleaning validation at Mallinckrodt. She has worked all around the United States performing GMP compliance audits, writing and executing cleaning validations, equipment qualifications, and performing technical writing.
With over 30 years total experience in the pharmaceutical and biologics industries, Ms. McElroy has gained extensive knowledge of quality assurance, process and cleaning validation, environmental monitoring, equipment qualification, sterilization, GMP compliance auditing, and technical writing. Joy currently works for Actalent Services, LLC as the Validation Manager for sciences where she works with a team of highly qualified technical individuals to provide managed services to pharmaceutical, medical device and biologics companies around the world.
This webinar will discuss how to write effective, clear and well-organized technical documents. In this webinar, you will learn how to write in the correct person using the most effective and attention-catching words. The attendees will learn how to write comprehensible clear-to-the-point statements. They will also learn the correct ways to formats to use for each type of Technical document.
- Competencies needed for writing technical documents
- Academic writing vs. Technical writing
- Examples of Technical documents used in the pharmaceutical, biologics, and medical device manufacturing industries
- Writing Instructions for use, IFUs, SOPs, Validation Protocols, Work Instructions, and final reports
- Benefits of good technical writing
Course Level - Intermediate
Who Should Attend
- Quality Assurance Personnel
- Validation Personnel
- Validation Management
- Manufacturing Personnel
- Quality Control Personnel
- Quality Management
- Engineering personnel
- Engineering Management
Why Should You Attend
You should attend this webinar to understand the importance of all types of technical writing, learn the major components and functions of technical writing, and gain clarity on the benefits of properly written well-organized technical documents.
Technical writing surrounds us every day. It is a specific type of writing that is used to present and communicate particular information to the reader. Technical writing presents information to help readers solve problems or gain a better understanding of a situation. The writing conveys technical, complex, or special information in a way that is easy for a non-technical reader to understand. Technical writing may document the way activities are to be performed to facilitate consistent conformance to technical and quality system requirements and to support data quality. It may describe fundamental programmatic or technical actions such as analytical processes, and processes for maintaining as well as calibrating and using equipment.
The development and use of technical documents are an integral part of a successful quality system. They provide information consistently to achieve a quality result.