Understand Steps of Deviation Investigation - 4 Webinars on Root Cause and CAPA

  Product ID : CAPA-FDA-0001

  Level : Intermediate


CAPA: Corrective and Preventative Actions and Addressing Non-Conformances

Presented by Michael Brodsky B

CAPA is both a precursor to and component of RCA that helps people prevent non-conformances from occurring and if all else fails; answer the question of why the non-conformance occurred in the first place. Root Cause Analysis (RCA) is a popular and often-used technique that helps people answer the question of why the problem. What is non-conformance? When you have a non-conformance in the laboratory, how do you approach it? Do you jump in and start treating the symptoms? Or do you stop to consider whether there's actually a deeper problem that needs your attention? If you only fix the symptoms – what you see on the surface – the problem will almost certainly happen again... which will lead you to fix it, again, and again, and again. If instead, you look deeper to figure out why the non-conformance is occurring, you can fix the underlying systems and processes that caused it.

Proper Root Cause Analysis

Presented by Danielle DeLucy

In many companies, deviation/non-conformance investigations are often criticized for the lack of a robust root cause analysis. The proper root cause can help a company in many ways. Root cause analysis helps identify what, how, and why something happened, thus preventing recurrence. Root causes are underlying, are reasonably identifiable, can be controlled by management, and allow for the generation of recommendations. The process involves data collection; cause charting, root cause identification, and recommendation generation and implementation.

Best Practices for Investigating Deviations

Presented by Danielle DeLucy

One of the most common FDA 483 and Warning Letter citations continues to be inadequate investigations. The FDA uses the investigation reports and investigation trends to identify potential quality problems in all areas of the company. Ultimately, inadequate investigations can lead to 483 citations, Warning Letters, a release of the sub-standard product, or product recall. Furthermore, costly and time-consuming system remediation may be required. Having a procedure on Deviation Investigations is not enough. It is the content and conclusions of the investigations themselves that truly count. Doing a proper root cause analysis, gathering evidence, and ensuring a sustainable corrective action is a key to a proper deviation investigation. This webinar will help attendees understand the fundamental investigation steps and skillsets. A key focus will be placed on identification and initial reporting of deviations, fact/evidence gathering, and arriving at the correct root cause and CAPA. The importance of investigation planning, critical thinking skills, and effective preventative action plans will also be discussed.

Medical Device Complaints and Corrective and Preventative Action (CAPA)

Presented by Edwin Waldbusser

Complaint handling and Corrective and Preventative Action (CAPA) is considered by the FDA to be two of the most important areas to assure medical device safety and efficacy. They are in the top five areas where FDA finds problems during inspections and issues 483’s. Medical device developers must understand the complicated Complaint and CAPA process and have a strong CAPA program. A key understanding is striking a balance between too many CAPA’s (strangles the system) and too few (problem areas escape fixing).

This webinar will explain the CAPA process from information gathering through MDR and Recall decision making to the final CAPA closing. Post-closing effectiveness evaluation is required and will be explained. Preventative Action is often neglected and will be discussed. Post distribution product monitoring including customer surveys will be explained. The integration of manufacturing non-conformities with the CAPA program will be discussed.


Michael Brodsky has been an Environmental Microbiologist for more than 44 years. He is a Past President of the Ontario Food Protection Association, the International Association for Food Protection, and AOAC International. He serves as co-Chair for the AOAC Expert Review Committee for Microbiology, as a scientific reviewer in Microbiology for the AOAC Official Methods of Analysis and the AOAC Research Institute. He is a reviewer for Standard Methods for the Examination of Water and Wastewater and a chapter co-editor on QA for the Compendium of Methods in Microbiology. He is an Exemplar Global Certified technical assessor in Microbiology for the Standards Council of Canada and also a lead auditor/assessor in microbiology for the Canadian Association for Laboratory Accreditation (CALA).



Danielle DeLucy, MS, is the owner of ASA Training and Consulting, LLC which provides Pharmaceutical and Biologics based companies with training and quality systems assistance in order to meet regulatory compliance. Prior to this role, Danielle has been in the industry for 15 years serving in numerous Quality Management Roles, such as the Director of Product Quality, the oversight of Sterility Assurance practices, and provided QA oversight of numerous filling and packaging operations.



Edwin Waldbusser retired from the industry after 30 years in management of the development of medical device products and development of company Quality Systems. He was involved in the development of products such as IVD devices, kidney dialysis systems, and inhalation devices. His QS experience includes design control, risk analysis, CAPA, software validation, supplier qualification/control, and manufacturing/non-conforming product programs.

This webinar bundle is ideal for all FDA regulated industries. These webinars will help attendees understand the fundamental steps of deviation investigation with a focus on using facts and objective evidence to arrive at root cause and CAPA. They also focus on how to avoid the pitfalls the mat occur during FDA investigations and help eliminate 482 observations. These courses will help you construct and maintain a strong but manageable compliant/CAPA system that will meet the FDA requirements.

The proper root cause can help a company in many ways. Root cause analysis helps identify what, how, and why something happened, thus preventing recurrence. Root causes are underlying, are reasonably identifiable, can be controlled by management, and allow for the generation of recommendations. The process involves data collection; cause charting, root cause identification, and recommendation generation and implementation.

The webinar format is 1-1.5 hours of audio-visual presentation, including a brief Q&A session.

This webinar bundle includes 4 recorded webinars:

CAPA: Corrective and Preventative Actions and Addressing Non-Conformances
Proper Root Cause Analysis
Best Practices for Investigating Deviations
Medical Device Complaints and Corrective and Preventative Action (CAPA)

  • $800.00


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