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
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
Treating Employees Like Adults: Discipline versus Empowerme…
7 Ways To Beat Burnout: Without Quitting Your Job
How to Write Procedures to Avoid Human Errors
Ethical Terminations: Navigating Employee Exits with Legal …
Understanding EBITDA – Definition, Formula & Calculation
Handbook Overhaul 2026: Compliance, OBBB Act & Beyond
FDA Proposes Framework to Advance Credibility of AI Models
Project Management for Non-Project Managers - Scheduling yo…
Data Integrity and Privacy: Compliance with 21 CFR Part 11,…
4-Hour Virtual Seminar on Hidden Secrets of Selling & Marke…
Validation Statistics for Non-Statisticians
Work Shouldn’t Feel Like A Soap Opera: Less Drama. More Foc…
Offboarding with Care: Conducting Legal & Ethical Employee …
The Alphabet Soup: When the FMLA, ADA, COBRA, and Workers' …
2-Hour Virtual Seminar on How to Conduct an Internal Harass…
Managing Toxic & Other Employees Who have Attitude Issues
Payments Fraud Detect & Prevent Check, ACH and P-Card Schem…
Reduce Stress in the Workplace: Effective Ways to Handle Co…
Language is Code - Intro to AI - Generative AI - ChatGPT an…
GROUPBY and PIVOTBY functions. Pivot table killers?
How to Prepare for a Regulatory Inspection: FDA, EMA, and N…
Excel - Reporting Simplified - Learn Pivot Tables from Scra…
The Power of Trust: Why It Should Matter to All Leaders & H…
California Meal and Rest Breaks: What You Don't Know Can Co…
How to Reduce Human Error in a GMP Manufacturing Floor
2-Hour Virtual Seminar on the 6 Most Common Problems in FDA…
Maximizing Productivity with ChatGPT: AI Solutions for HR, …
Excel - Pivot Tables - The Key To Modern Data Analysis and …
Re-imagine Finance & Accounting Made Simple. Three Webinars…
Form W-9 Compliance to Avoid Penalties: TIN Verification, B…
21 CFR Part 11 - Compliance for Electronic Records and Sign…
New EEOC Report: Workplace Harassment Prevention Not Workin…
Transforming Change and Conflict into Diverse-Inclusive-Col…
ChatGPT and Project Management: Leveraging AI for Project M…
Excel Power Skills: Master Functions, Formulas, and Macros …
Construction Lending And Real Credit Administration: Evalua…
Develop People Intelligence: Is Your Communication Style as…