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The quality control (QC) process is a critical step in finalizing regulatory documents. Medical writers may have personal preferences on how to send documents for QC, and companies often have checklists to ensure the QC process is complete. However, what about the finer details that impact timelines and sanity for the QC specialist? How should a medical writer annotate a document for QC? How do you accurately estimate time to complete QC? What are the downstream effects of shifting timelines? In this webinar, a medical writer and QC expert will discuss what it takes to make QC run smoothly and how to tackle common dilemmas.
At the conclusion of this webinar, learners will be able to
- Describe the relationship between the medical writer and QC specialist.
- Optimize personal workflow for efficient QC.
- Explain ways to manage common QC problems.
Learning Level: Basic, Intermediate
Content Areas: Regulatory
About the Presenters
Amanda Pennington received her B.S. from Millersville University in Science Education. Formerly a middle school science teacher, Amanda has designed and implemented curriculum, trained new teachers, and frequently presented at the Maryland Science Teacher Association conferences as well as at local schools. With a science/education/training background, technical writing was a perfect fit. Amanda has been a regulatory medical writer for more than 10 years as a writer, editor, proofreader, linguistic editor, and quality control analyst. Currently a QC Reviewer at Whitsell Innovations, Inc., she has been on both sides of the Medical Writer/QC process. She serves on the QC task force and helps develop formal QC processes for WI.
Ashley Khan earned a BA in Rhetoric and Communication Studies from the University of Richmond and a PharmD from Virginia Commonwealth University. Ashley has practiced as a pharmacist for health systems in Virginia and North Carolina since 2009. She also works as a medical writer at Whitsell Innovations, Inc., with a primary focus on authoring and editing NDA/MAA submission documents across the clinical and CMC spectra. In this position, she works with various QC specialists, both in-house and externally, which has shown her diverse approaches to QC processes.