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Effectiveness Checks Training

QSR Medical DevicesEFFECTIVENESS CHECKS TRAINING COURSE OVERVIEW:

Our Effectiveness Checks training module is designed to aid your organization in learning about regulatory expectations and methodologies for more robust Effectiveness Checks. We address key issues organizations struggle when developing Effectiveness Checks and measures. This module clarifies key topics for those involved in developing or reviewing Effectiveness Checks. Schedule this training as an individual training module or add it to your Investigations and CAPA course. 

Participants will improve their ability to:Quality Event

  • Describe regulatory expectations for effectiveness checks
  • Examine risk-based thinking for effectiveness checks
  • Identify methods and data used in establishing effectiveness checks
  • Discuss verification and validation activities
  • Develop effectiveness check plans
HIGH IMPACT TOPICS:

  • How to plan Effectiveness Checks as a part of the Investigation and CAPA System.
  • How clearly written Effectiveness Checks improve implementation.
  • How properly implemented solutions achieve success for the individual and the organization.

BENEFITS:

  • Increase implementation success.
  • Cultivate a robust CAPA system.
  • Reduce repeat events.

Effectiveness Checks is appropriate for individuals who are regularly called upon to develop, execute or review Effectiveness Checks as a part of the Investigations and CAPA Quality System. Examples include manufacturing personnel, investigators, laboratory functions, QA/RA functions, managers, manufacturing supervisors, technicians, and engineers.

Effectiveness Checks instructor-led training is a half-day course. 

Effectiveness Checks 1/2 day training is worth .4 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.

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

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

REQUEST A QUOTE FOR TRAINING! 


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PathWise workshopsWe 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.  
INVESTIGATIONS & CORRECTIVE AND PREVENTIVE ACTION (CAPA) WHITE PAPERS
6 Ways to Identify Root Cause QuicklyCorrective Action or Correction- Which is it?
Interview Skills For InvestigatorsBest Practices for Effectiveness Checks For CAPA
Avoid Traps When Using the 5 Why'sOut of Specification (OOS) Investigations: Back To Basics
Does Your Culture Need a CAPA?Establishing a Compliant and Risk Based CAPA System
Conducting InvestigationsWhy do we Have Repeat Investigations?
It's OK To Document an Event Without Looking for Root CauseWhy Do We Triage?
Examples of Conducting Investigations Why Trending is Important for RCA and Breakthrough Improvement
Three Key Statements for InvestigationsHow to Set Up Effectiveness Checks
Seven Things to Consider in Deviation InvestigationsCAPA Summaries
7 Questions for Effectiveness ChecksWhy is Is Is Not
Standard Work for Problem SolvingAdverse Event Reporting
Standard Work for Problem SolvingNonconforming Materials Report: Example
Capturing JustificationsNonconforming Materials Reporting
The Value of a Compliant, Effective, and Efficient CAPA SystemWrite Effective Root Cause Statements to Ensure Strong CAPAs
Out of Tolerance Calibrations- Assessing the ImpactOut of Specification (OOS) Investigation Checklist
Effective Management of Supplier Corrective Action RequestsWhat to do about Human Error Deviations?
What is the RIght Number of CAPAs?What is Human Error and Strategies for Addressing It?
Identifying and Overcoming Human ErrorGoing Beyond Human Error