Compliance4All, Online
2017-01-04
Overview: Medical Device managers, engineers, QA personnel, as well as lean
program leaders. Do you find yourself constantly struggling to create,
manage, and maintain all of the information found in Corrective and
Preventive Actions (CAPA)which is often redundant, repetitive, and
chained together in a cumbersome way?
Areas Covered in the Session: Brief introduction to Lean Documents and Lean Configuration Quality System Regulation, 21 CFR Part 820, and ISO 13485 as these
apply to design control documents Alignment of the Six Sigma DMAIC approach to CAPA Applying lean principles to documenting and tracking non-
conformances Applying lean principles to investigating and resolving non-
conformances Applying lean principles to instituting corrective and preventive actions
Who Will Benefit: Managers, Supervisors, Directors, and Vice-Presidents R&D Manufacturing Engineering Design Assurance Quality Assurance Operations Document Control
|