This 4-hour program will be divided into two sessions taking place on May 6 and 20, 2020
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 - May 6, 2020, 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 - May 20, 2020 - 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.
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