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Instructor Led Virtual Training

INVESTIGATIONS AND CAPA

Investigations and CAPA are continually the top 483 finding by the FDA each year. Learn effective tools and processes to meet requirements mandated by world regulatory bodies for investigations and corrective and preventive actions.

CAPA Training

INVESTIGATIONS AND CAPA COURSE OVERVIEW:

This CAPA training course will help you investigate problems in a quality system. We use an interactive approach to show how to effectively apply risk-based methodology throughout the investigation process. As a result, course attendees will be ready when problems occur, and ready to prevent future problems. Specifically, we focus on how you identify issues. Additionally, we instruct how to assess and prioritize these issues, or non-conformances. Finally, we cover how to investigate to root cause, and implement corrective and/or preventive actions.  Ultimately, our investigations and CAPA course can support your organization to reduce repeat CAPAs, and improve root cause identification.

LEARNING OBJECTIVES FOR INVESTIGATIONS AND CAPA TRAINING:

The PathWise Investigations and CAPA training course covers four modules. These modules explore the following learning objectives:

INTRODUCTION

  • Identify and distinguish between a correction, corrective action and preventive action.
  • Identify regulatory requirements for Investigations and CAPA

EVALUATE

  • Write effective problem statements
  • Conduct Risk Analysis and assess impact
  • Understand and use techniques for interviewing

INVESTIGATE

  • Gather specifics
  • Conduct root cause analysis.
    1. Systematically find cause(s)
    2. Establish causal relationships
    3. Use quality tools: 5 Whys, Fishbone, IS/IS NOT
  • Identify a process to verify root cause

IMPLEMENT

  • Identify a process to implement corrective/preventive actions.
  • Understand project management tools available
  • Write a strong Corrective/Preventive Action
  • Understand effectiveness check and verification requirements
  • Manage and track actions in implementation

These topics covered will have a strong impact on the success of your organization. They are thoroughly covered, to ensure the best Investigations and CAPA training. Our training is highly interactive, with engaging activities, and case studies, to ensure participants understand the concepts.

HIGH IMPACT TOPICS

  • How to gather specifics to support an investigation.
  • How to assess impact to process and product.
  • How to check effectiveness of solutions implemented.

POSSIBLE BENEFITS FOR YOUR ORGANIZATION

  • Reduce repeat investigations
  • Improve root cause identification.
  • Shorten investigation cycle time.
  • Identify most effective actions.

INVESTIGATIONS/CAPA TRAINING ATTENDEES

Investigations and CAPA is appropriate for individuals in biomedical, pharmaceutical, medical device or biologics who are called upon to investigate problems in a quality system.

Examples include investigators, laboratory functions, QA/RA functions, managers, or manufacturing supervisors.

 

Investigations and CAPA 2 day training is worth 1.5 credits.

PathWise is accredited by the International Association for Continuing Education and Training (IACET).  PathWise complies with the ANSI/IACET Standard, which is recognized internationally as a standard of excellence in instructional practices. As a result of this accreditation, PathWise is accredited to issue the IACET CEU.

 

PathWise workshops

We understand that training is essential to achieve and maintain a compliant, effective and efficient quality system. As a result, 90% of our courses are taught on-site at our client’s locations.  For individuals and organizations in need of training but unable to make an on-site training commitment, we offer many of our courses as events at a variety of locations across the globe.

View the PathWise Events page to find out about our options for a public workshop.

The most cost effective training option is to have PathWise come to your location. We have trainers across the globe, covering almost every continent!

We can also conduct virtual training

To schedule a course at your site fill out the form and a PathWise representative will get back with you shortly!


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Read what our customers have to say about Investigations and CAPA training!

I have been doing CAPA’s for 19 years, but never like this – great tools and presentation to help understand processes better to take back and add to our company’s process.

Kimberly Bulls

RA and Compliance Specialist Label Control Manager, Techlab, Inc

After receiving training through PathWise, we certainly see a general improvement in our CAPA process, including Root Cause Analysis and Documentation..There is also a reduction in the number of open CAPAs, resulting in less people being involved and less pressure for our organization.

Hans Willems

Vice President, Operations , Boston Scientific

No travel? No problem! PathWise Has Virtual Classrooms!

Internal training is essential to achieve and maintain a compliant, effective, and efficient quality system! Don't let Covid derail your important goals and initiatives.

PathWise training will help you:

  • Remain FDA compliant with qualified staff 
  • Earn Continuing Education Credit to maintain certifications such as ASQ
  • Align expectations across your organization
  • Increase employee engagement and ownership for your overall Quality System