Deviations, Investigations and CAPA Workshop
San Francisco, California
8:30am - 4:30pm
This is a hands-on workshop that gives you ample time to practice what you learn and will cover the following topics:
Examples of Sources of Failures
FDA Expectations for Investigations
Writing Deviations – Problem Definition/Impact Assessment (Risks/Liabilities)/Material Disposition
Group Activity – Break into groups to write an effective problem definition and do Impact Assessment (topics to be given will include API issue, Drug product issue, temperature excursion, labeling issue, shipping issue, complaints
Performing Root Cause Analysis – Review different methods for RCA (5 Whys, Fishbone/FMEA Analysis/Brainstorming, Pareto Charts/Trend Charts)-Spokesperson for each group to present their work to the audience for critique/improvement.
Group Activity – Continue with the problem definition to do a RCA- Spokesperson for each group to present their work to the audience for critique/improvement.
Developing an effective CAPA plan for the same scenario above
Group Activity-Continue with the investigation to do a CAPA- Spokesperson for each group to present their work to the audience for critique/improvement.
After the completion of this course, you will be able to:
Improve your ability to write a clear, concise deviation report
Perform a thorough investigation
Write an effective CAPA plan
Minimize regulatory liability by appropriately documenting findings
Enhance your understanding of what the FDA expects to see from a deviation/CAPA reporting system
About the instructor:
Lisa Helmonds is Vice President of MWA Consulting, Inc. She has over 30 years of industrial training in the areas of Manufacturing and Quality Assurance in the pharmaceutical, biotechnology and medical device industries.
She has extensive GxP knowledge, has worked with several startups and large companies, and understands the challenges facing the industry.
She holds a BS in Zoology from the University of Rhode Island and an MBA from Santa Clara University.
Her current focus at MWA Consulting is on developing and maintaining relationships with MWA’s clients, implementing training programs, and ensuring that MWA’s consulting team continues to offer the highest quality consulting services in the industry.
8:00 am – Registration/Breakfast
12:00 pm – Lunch
5:00 pm – Closing
6:00pm – Complimentary entrance to the “21st century cGMP training” seminar (optional to attend)
Contact Phone: 6502968044
Contact Email: firstname.lastname@example.org
WellsFargo Event Center
333 Market St
San Francisco, CA 94105