Root Cause Investigation for CAPA

Regulatory agencies expect timely, successful investigations, they expect documentation of all investigation activities, as well as the results of those activities. It is essential for regulatory professionals to understand what an investigation entails and how to avoid common pitfalls and overcome challenges during the process. 

This interactive, virtual event will break down the investigation into a step-by-step process, leveraging straightforward tools that capture the work being conducted in real-time. Participants will be able to immediately apply the methodology, including what documentation to look for when reviewing the investigative work of others.

During this three-day workshop participants will first be introduced to the methodology and then immersed in practical exercises to leverage the instructor-led case studies. By working in small groups, participants will be able to immediately apply the methodology in a real-life case study. On day two, participants will work to develop their skills through practice with a more advanced case study.

Participants will be provided with a toolkit that includes a training manual, an investigation roadmap, and a set of electronic templates to reference. This set of tools will guide participants through the methodology to establish the basis for documentation.

NOTE: Advance registration is required for this workshop, therefore participants are encouraged to register early. Onsite registrations are not accepted.

Pricing Amounts & Deadlines

7 December 2021 – 26 June 2022: Regular $825 Member | $970 Nonmember

26 June 2022 – 26 July  2022: Regular $970 Member | $1,150 Nonmember

Learning Objectives

Root Cause Investigation for Correction and Preventative Action (CAPA) is a globally renowned methodology for investigating technical performance challenges. Problem solving techniques from Six Sigma, 8D, Kaizen, DMAIC, TQM and others 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.

Who Should Attend?

People who need to investigate technical performance changes.

Agenda

TBD

Instructor:

Robert Weaver, founded Weaver Consulting 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)..

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 following the workshop.

Questions

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