Root Cause Investigation for CAPA

Root Cause Investigation for Correction and Preventative Action (CAPA) is a globally renown methodology for investigating technical performance challenges. During this two-day online workshop, participants will be introduced to the methodology and then immersed in practical exercises to leverage the instructor-led case studies.

Root cause methodology to be covered includes problem solving techniques from Six Sigma, 8D, Kaizen, DMAIC, TQM and others that are leveraged to identify:

• Technical root causes which are the changes that occurred resulting in performance decline.
• Systemic root causes which are the failures that allowed the change to occur.
• Corrective and preventive actions which restore performance to previous levels or requirements.
• A control plan to monitor and prevent recurrence.

Attendees will be provided resources including a training manual, investigation roadmap, and set of electronic templates to reference. This set of tools will be useful in guiding participants through the methodology to establish the basis for documentation. Participants will work in small groups to apply the methodology and further develop their skills using real-life case studies.

Pricing Amounts & Deadlines

12 December 2020 – 15 January 2021: $800 Member | $900 Nonmember
16 January 2021 – 15 February 2021: $900 Member | $1000 Nonmember

Agenda Overview

Tuesday, 16 February (9:00am–5:00pm)

• Defining the performance problem
• Collecting data
• Identifying possible causes
• Testing possible causes

Wednesday, 17 February (9:00am-5:00pm)

• Developing problem statement
• Developing data collection plan
• Selecting and testing possible causes
• Comparing and contrasting the investigation methodology

Speakers

Robert Weaver, President, Weaver Consulting

Founded in 2003, Weaver Consulting is solely focused on root cause analysis. Comprised of former Vice Presidents and quality/operations consultants Rob and Tom Weaver (Wells Fargo & Company and Baxter Healthcare), they teach a proven, disciplined methodology to achieve optimal results in as little time as possible while simultaneously ensuring robust documentation meeting the stringent requirements highly regulated industries demand. Their premier methodology, Root Cause Investigation for CAPA, is designed for investigating technical performance challenges. Problem solving techniques from Six Sigma, 8D, Kaizen, DMAIC, TQM and others are leveraged to identify technical and systemic root causes, then implement corrective actions to restore performance to previous levels or requirements, and a control plan to monitor and prevent or minimize future recurrence.

Weaver Consulting’s global client base encompasses a multitude of highly regulated industries, including pharmaceutical, medical device, aerospace & defense, automotive, food & beverage, financial services, semiconductor, and more. Some of their customers include highly recognizable organizations such as Google, Boeing, Johnson & Johnson, Citibank, Northrup Grumman, Federal Aviation Administration (FAA), Medtronic, and Apple.

Weaver Consulting have been featured speaker’s with: Food and Drug Administration (FDA), American Society of Quality, Regulatory Affairs Professionals Society, Food Safety Consortium, Food Safety Tech, Parenteral Drug Association, Sparta Connection (TrackWise), Medical Device & Manufacturing, Center for Professional Advancement, and Medtech. They’ve been published or interviewed with: American Pharmaceutical Review and Medtech Insight (The Gray Sheet).

Nancy Singer, President, Compliance Alliance

Nancy Singer founded Compliance-Alliance LLC in 2004 to specialize in the professional development for government, association, and business professionals. She is on the faculty of George Washington University School of Medicine and Health Sciences, and she has taught classes at Johns Hopkins University, University of Southern California, and Harvard Symposia. She currently teaches CDRH reviewers at the center’s staff college and the investigators at ORA University. Previously, she served as Special Counsel for the Advanced Medical Technology Association. For her efforts to improve communication between the government and the regulated industry, Nancy received Vice President Gore’s Reinventing Government Hammer Award and the FDA Commissioner’s Special Citation. She began her career as an attorney with the United States Department of Justice doing litigation for FDA enforcement cases. Subsequently she was a partner at the law firm of Kleinfeld Kaplan and Becker. Nancy is a retired commander in the Naval Reserve.

Cancellation Policy

RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. All cancellation requests must be submitted in writing via our online cancellation form. RAPS is unable to accept cancellations by phone. Please specify the name of the person registered and the event title. Substitutions may be accepted with written approval from RAPS and must be submitted to raps@raps.org.

Proof of Attendance

RAPS will send an electronic letter or a certificate of attendance upon request.

Questions

Call RAPS Solutions Center at +1 301.770.2920, Ext 200 or email raps@raps.org.