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Management : Death by CAPA - Does your Company have the Symptoms?

CAPA program,Management ,Airport management, Travel & tourism,Airport, Aviation


NetZealous LLC

Summary

Price
£170 inc VAT
Or £56.67/mo. for 3 months...
Study method
Online, self-paced
Duration
2 hours
Access to content
6 months
Qualification
No formal qualification
Optional extras

Digital certificate included in price

Additional info
  • Tutor is available to students

2 students purchased this course

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Overview

CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from a slow, bureaucratic, ineffective CAPA process.

Not only do they fail to achieve necessary improvements, they waste precious time and resources. This webinar will help you avoid those struggles and establish an efficient and effective CAPA process leading to improved quality and compliance for your company. You'll learn how to streamline and monitor your process to ensure compliance and improved performance. If your CAPA process needs a CAPA, this webinar is for you.

We'll discuss requirements, the myths, and the challenges of managing CAPAs so you can avoid common problems and pitfalls. We'll discuss best practices so you can start off on the right foot and always be prepared for an inspection.

Description

Why you should Attend:

Many companies struggle to establish and maintain a CAPA program that is efficient and effective. An ineffective CAPA System leads to disastrous consequences such as medical device reports, recalls, 483s, and warning letters. And an inefficient CAPA program results in wasted time, money, and missed opportunities. In this webinar, we'll discuss the fundamentals of a CAPA program and how you can make your CAPA program more efficient and more effective.

Areas Covered in the Session:

  • FDA and NB expectations for CAPA
  • Lessons Learned from 483s and warning letters
  • Common problems and simple solutions
  • How to structure your CAPA process
  • How to use IT tools to monitor and maintain your CAPAs
  • Metrics to ensure your CAPAs are timely and effective
  • A toolkit for CAPA
  • Best Practices


Learning Objectives:

  • Overview of the Regulations
  • FDA Expectations
  • CAPA Process
  • Lessons Learned and Common Mistakes
  • Preparing for an FDA Inspection

Who is this course for?

  • Quality Systems Specialists
  • Document Control Specialists
  • Quality and Compliance Specialists
  • Internal Auditors and Managers
  • Training Specialists
  • CAPA Specialists
  • Supplier Quality Engineers and Auditors
  • Quality/Compliance Managers or Directors for Medical Device companies
  • General Managers wanting to Learn How to Understand Quality System Requirements

Questions and answers

Currently there are no Q&As for this course. Be the first to ask a question.

Optional extras

Digital certificate

Certificate of completion is included in course price

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FAQs

What does study method mean?

Study method describes the format in which the course will be delivered. At Reed Courses, courses are delivered in a number of ways, including online courses, where the course content can be accessed online remotely, and classroom courses, where courses are delivered in person at a classroom venue.

What are CPD hours/points?

CPD stands for Continuing Professional Development. If you work in certain professions or for certain companies, your employer may require you to complete a number of CPD hours or points, per year. You can find a range of CPD courses on Reed Courses, many of which can be completed online.

What is a ‘regulated qualification’?

A regulated qualification is delivered by a learning institution which is regulated by a government body. In England, the government body which regulates courses is Ofqual. Ofqual regulated qualifications sit on the Regulated Qualifications Framework (RQF), which can help students understand how different qualifications in different fields compare to each other. The framework also helps students to understand what qualifications they need to progress towards a higher learning goal, such as a university degree or equivalent higher education award.

What is an ‘endorsed’ course?

An endorsed course is a skills based course which has been checked over and approved by an independent awarding body. Endorsed courses are not regulated so do not result in a qualification - however, the student can usually purchase a certificate showing the awarding body’s logo if they wish. Certain awarding bodies - such as Quality Licence Scheme and TQUK - have developed endorsement schemes as a way to help students select the best skills based courses for them.