About the Workshop

This 4-hour training program will be divided into 2 sessions taking place on September 5
and September 19, 2019.  These are live broadcasts.

Many people know about nonconformances, many know about CAPAs, but not that many know about how a nonconformance LEADS to a CAPA.

They also don’t necessarily know how to derive data analytics from these systems. What is being proposed is having everything become an “event” and then take it from there to escalation, but essentially all pre-CAPA inputs are handled the same way.

Why not have a standard approach to documenting, investigating, detailing, and resolving?

Even the best college educated folks really don’t know what is expected in the medical device, food and beverage, pharma, pharmacy, biologics and cannabis corporate world, especially when it comes to writing up non-conformances and CAPAs.

Learning Objectives

This course is not meant to be comprehensive; however, it is a guide for better use odf the data derived from recording nonconformances (OOT, OOS, Audit observations, Complaints, nonconforming product, etc.)

Attendees will gain knowledge as to a more standardized way of recording, investigating, and resolving nonconformances, as well as use the recorded data to more effectively communicate tracking and trending of issues.

They will will also be able to use the data to assign costs of the resolution and be able to present new key performance indicators to executive management.

Course Outline

I. Problem resolution philosophy (Six Step Problem Solving Process)

II. Practical application of the problem solving process

III. Advantages of using a single system of problem investigation and resolution

IV. Actual Event Report Form use

V. Event Data Analytics

VI. Report form and Data Analytics Side-by-Side Comparison

VII. How and Event turns into a CAPA

VIII. CAPA Data Analytics

IX. Cost of Poor Quality Data Analytics

X. Q&A

Who would benefit from this course:

1. Manufacturing technicians

2. Manufacturing engineers

3. Quality Assurance

4. Regulatory Affairs

5. Mid-level management/supervisors

6. Executive management

CEU Information

Amount of CEUs: 
Certificates will be issued that explain hours of training, CEUs to be issued by license authorizing organization.

  • When

  • Thursday, September 5, 2019 - Thursday, September 19, 2019
    12:00 PM - 2:00 PM

  • Where

  • Virtual Conference

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