About the Conference

This 4-hour program will be divided into two sessions taking place on Oct. 17 and Oct. 31, 2019. 


Learning Objectives

This course is not meant to be comprehensive; however, it is a guide for better use of Corrective and Preventive Actions. Attendees will gain “old school” knowledge of what CAPA is all about, with a contemporary use of this data once collected. They 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 that has practical application and gets executive management engagement.  


Course Outline - First Class - Oct. 17, 12:00 pm - 2 pm ET (2 hours)

I. CAPA Compliance – Importance to FDA, impact to businesses

II. DMAIC Approach to CAPA

III. CAPA Inputs, Scoping, & File Creation

IV. CAPA Elements

V. Industry Expectations

VI. Using CAPA to “Connect the Dots” in the company

VII. CAPA Data Analytics


Course Outline - Second Class - Oct. 31, 2019 - 12 Noon- 2 pm ET (2 hours)

    I.   Industry Examples

    II.  Breakdown and Grading of Samples

    III. 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, October 17, 2019 - Thursday, October 31, 2019
    12:00 PM - 2:00 PM

  • Where

  • Virtual Conference

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