Guest Speaker: Rob Miller, Vice President and Partner, Working Words Inc.
All pharmaceutical, biopharmaceutical, and medical device organizations face the challenge of continually improving good manufacturing practices and documentation, and everyone is aware of the costs of poor investigations and CAPA. While an automated CAPA system goes a long way in capturing data, trending root causes, and tracking corrective and preventive actions taken, the quality of an investigation report is only as good as the writing that goes into the system.
This webinar will address some of the pressures and challenges faced in FDA-regulated manufacturing, and how companies can take a systems approach to addressing investigations and CAPA. More specifically, the presentation will review how one company used Six Sigma's DMAIC methodology to improve their investigation system by: defining the project needs, measuring current and desired performance, analyzing what inputs affected the system, improving processes and procedures, implementing training, and finally, controlling long-term performance. Along with common problems in investigation and CAPA reports, the presentation will offer a closer look at some myths and misconceptions about writing in the scientific and technical business environment. The program will conclude with a demonstration of how improved critical thinking and effective technical writing skills impact not only the quality of investigation and CAPA reports, but also product quality and compliance.
You will understand:
- How training for training for critical thinking, root cause analysis, and technical writing can be used as strategic tool for process improvement.
- Common problems with investigation reports and the challenges writers and investigators face.
- How you can apply one pharmaceutical company's best practices for training in technical writing and critical thinking/root cause analysis.
- The business results this training methodology achieved for improving compliance in investigations and reducing deviations in production.
At the conclusion of the presentation you will understand:
- the "what" and "why" of validation for quality management systems.
- keys to executing an efficient and successful validation effort.
- how to use risk based approaches to focus validation on critical functionality.
- ways to leverage different kinds of vendor supplied compliance documentation.
- the additional controls required to maintain the system in a validated state.
Your Speaker: Rob Miller brings 20 years of both pharmaceutical and entrepreneurial expertise to Working Words Inc. where he is Vice President and Partner. He has been instrumental in helping many large pharmaceutical, biopharmaceutical, and medical device organizations to improve their quality systems and quality documentation, including investigations, SOPs, regulatory submissions, clinical protocols and reports, and validation protocols and reports. Rob has worked as a biochemist at Merck & Co. and Sterling Winthrop, and prior to joining Working Words, he was an owner in two small businesses that served the pharmaceutical, biotechnology, and other technology-based industries. He has a Bachelor's of Science degree in Biochemistry and Master's degree in Business Administration.