In order to solve problems every organization must know how to conduct an effective investigation, identify root causes, and implement workable corrective action in a timely manner. An effective CAPA process requires training internal investigators, who can also coach others in the organization, to employ critical thinking. The process must provide a common model and language within the organization, which allows investigators to master the process quickly and easily.
WHY SHOULD YOU ATTEND?
This webinar will include discussions proper CAPA system maintenance, root cause analysis, documentation of the Corrective and Preventative Actions and developing a robust CAPA plan. It will give tips on how to develop CAPAs pertaining to longer term projects and ensure they stay on track.
AREA COVERED
- CAPA Definition
- When is a CAPA required
- Developing crucial pieces of a strong CAPA plan
- Root Cause Analysis Methods
- Discussing various Root Cause Analysis methods and their benefits
- Establishment a CAPA Plan
- Project Summary development
- Individual responsibilities involved
- Finalizing Completion Dates
- Creating meaningful effectiveness checks
- Managing the CAPA System
- Maintaining proper documentation of the CAPA plans
- Ensuring CAPA plans are progressing
- Proper close out of CAPA plans
LEARNING OBJECTIVES
- Discuss what to do when problems occur
- Outline the requirements of the CAPA process and procedure including building a CAPA file
- Choose the most appropriate Root Cause Analysis methods for the situation
- Establishing a CAPA plan: project summary, individual responsibilities and expected completion dates
- Management and Oversight of the CAPA system and its documentation
WHO WILL BENEFIT?
- Quality Control Personnel & Management
- Manufacturing Personnel & Management
- Senior Management
- Regulatory Affairs Personnel & Management
- Quality Assurance Personnel & Management
- Supplier Quality Personnel & Management
This webinar will include discussions proper CAPA system maintenance, root cause analysis, documentation of the Corrective and Preventative Actions and developing a robust CAPA plan. It will give tips on how to develop CAPAs pertaining to longer term projects and ensure they stay on track.
- CAPA Definition
- When is a CAPA required
- Developing crucial pieces of a strong CAPA plan
- Root Cause Analysis Methods
- Discussing various Root Cause Analysis methods and their benefits
- Establishment a CAPA Plan
- Project Summary development
- Individual responsibilities involved
- Finalizing Completion Dates
- Creating meaningful effectiveness checks
- Managing the CAPA System
- Maintaining proper documentation of the CAPA plans
- Ensuring CAPA plans are progressing
- Proper close out of CAPA plans
- Discuss what to do when problems occur
- Outline the requirements of the CAPA process and procedure including building a CAPA file
- Choose the most appropriate Root Cause Analysis methods for the situation
- Establishing a CAPA plan: project summary, individual responsibilities and expected completion dates
- Management and Oversight of the CAPA system and its documentation
- Quality Control Personnel & Management
- Manufacturing Personnel & Management
- Senior Management
- Regulatory Affairs Personnel & Management
- Quality Assurance Personnel & Management
- Supplier Quality Personnel & Management
Speaker Profile

Danielle DeLucy, MS, is 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. Danielle began her QA career as a Quality Control Pharmaceutical Microbiologist at a contract laboratory where she performed various tests for their clients. In the years after, she …
Upcoming Webinars

Interactive dashboards & analytics in Excel

Copilot and HR: An Introduction for HR Professionals

4-Hour Virtual Seminar on Bootcamp on Excel

Leading Across Generations: 5 Challenges & 10 Strategies to…


I-9 Audits: Strengthening Your Immigration Compliance Strat…

Fair Lending in 2025: New Regulations, Examinations and Enf…


Tattoos, hijabs, piercings, and pink hair: The challenges …

Using Emotional Intelligence to Elevate Your Leadership

ChatGPT & HR: How HR Recruiting Professionals Can Leverage …

FDA Trends in Compliance and Enforcement in Computer System…

Elevate Your Workplace Wellness: 10 Critical Wellness Facto…

How to Manage the Legal Landmine of the FMLA, ADA and Worke…

How to Write a Successful Job Hazard Analysis


How to Write Right for Better Business Communication

How to Prepare For and Host a FDA Inspection and Respond to…

Public Speaking: Overcoming The Fear of Public Speaking

From Good to Great: The Secrets to an Optimized LinkedIn Pr…



Workplace Investigations 101: How to Conduct your Investiga…

Policy Pops: Navigating DEI in the 2025 Workplace: Strategi…

The Five Cs Of Commercial Credit: The Basic Elements Of Cre…

Transforming Anger And Conflict Into Collaborative Problem …


Navigating Alcohol and Drug Addiction Protections Under the…


Reduce Stress in the Workplace: Effective Ways to Handle Co…



Transforming HR with AI: Unlocking Excellence and Innovation

Creating Employee Handbooks that Protect You and Support th…

FDA Technology Modernization Action Plan (TMAP) and Impact …


Transform Data into Insights: A Beginners Guide to Excel Pi…


Mindful Communication:The Key to Meaningful Conversations i…

FDA Proposes Framework to Advance Credibility of AI Models

50+ new Excel features so far this decade

FMLA Compliance in 2025: A Comprehensive Guide & Strategies…

Excel - 10 Key Worksheet Functions to Skyrocket Your Produc…

Managing Toxic Employees: Strategies For Leaders To Effecti…

Hiring and Retaining Employees in this Crazy Economy

Harassment, Bullying, Gossip, Confrontational and Disruptiv…