Presenter:
Lisa Smith, Sr. Consultant & Technical Trainer, Working Words Inc.
Lisa R. Smith is a Senior Consultant and Technical Trainer with Working Words Inc., which specializes in quality systems and process improvement, as well as training in technical, regulatory, and medical writing for the pharmaceutical/biotechnology/medical device industry. Lisa has over 20 years of management experience in applying quality and process improvement tools to manufacturing and laboratory operations. She is a Certified Lean Six Sigma Master Black Belt and has led project teams in improving processes for: CAPA systems, batch record review, manufacturing change-over, out-of-specification investigations, management and QA data systems, environmental monitoring, and more. Prior to joining Working words, Lisa was an Operational Excellence Manager at Biogen Idec, and served in various roles at Wyeth, Bespak, W.L. Gore, and Boeing.
Six Sigma, Lean Manufacturing, and now, Lean Six Sigma are process improvement tools that have been used for manufacturing operations for over 20 years, and in recent years, the pharmaceutical industry has begun to adopt these techniques for FDA-regulated manufacturing. These methodologies can be used to improve a wide variety of systems within GMP manufacturing environments including change control, manufacturing change over, OOS investigations, CAPA, management and QA data systems, batch records and review, environmental monitoring, and many more.
In addition, in the life science industry, FDA and other regulatory agencies mandate that any deviation from normal procedure needs to be investigated and documented. The impact of these deviations must be evaluated and appropriate corrective and preventive actions must be implemented. When introducing new products or new people to the production process, the investigation of such deviations can create significant bottleneck for any operation which can decrease manufacturing efficiencies and increase costs.
This talk will present a case study on how Lean Six Sigma tools can be used to streamline the deviation investigation process and therefore, improve the deviation cycle time. Improving the deviation process is a significant benefit to organizations because it enables employees to focus their time on implementing effective corrective and preventive actions rather than processing deviations.
During this webinar, you will learn:
- How to apply six sigma (DMAIC) process improvement to life science manufacturing systems and processes, specifically the investigation/CAPA system.
- Understand common problems with investigation reports and the challenges investigators and report writers face.
- How one pharmaceutical company applied best practices for training in technical writing and critical thinking/root cause analysis as part of a process improvement initiative for the deviation investigation system.
- The business results this initiative achieved for improving compliance in investigations and reducing deviation investigation cycle time.
Who should attend this Webinar?
Quality, Regulatory, Manufacturing, Operations, Compliance