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Medical Device Complaints & CAPA -USD 229

Publish Date: 11-10-2018 06:20:14 | Contact name: Sam Miller | Location: USA | Place: Online | 1 times displayed |



Description :

This webinar will explain the CAPA process from
information gathering through MDR and Recall decision making to final CAPA
closing. Post closing effectiveness evaluation is required and will be
explained. Preventative Action is often neglected and will be discussed. Post
distribution product monitoring including customer surveys will be explained.
Integration of manufacturing non conformaties with the CAPA program will be
discussed.

Why :

Complaint handling and Corrective and
Preventative Action (CAPA) is considered by the FDA to be two of the most
important areas to assure medical device safety and efficacy. They are in the
top five areas where FDA finds problems during inspections and issues 483’s.
Medical device developers must understand the complicated Complaint and CAPA
process and have a strong CAPA program. A key understanding is striking a
balance between too many CAPA’s (strangles the system) and too few (problem
areas escape fixing).

After this course, you will be able to construct
and maintain a strong but manageable Complaint/ CAPA system that will satisfy
FDA requirements

Templates of the Complaint Evaluation form and
the Corrective Action Plan will be handouts

How using the same logic as the auditors can
help you be in a state of constant readiness.



Areas Covered in the Session :

CAPA phases to be discussed



1. Sources of
information (complaints)



2. Information
gathering & proactive information gathering



3. Information
evaluation (is it a Complaint, is it a CAPA, should it be investigated)



4. Risk analysis
applied to CAPA



5. Root cause
determination



6. CAPA Investigation
Report & CAPA action Plan



7. Verification/
Validation of CAPA action



8. Post closing
effectiveness check



9. CAPA program
metrics




Who Will Benefit:



1. Medical device
engineering



2. Regulatory



3. Quality Assurance



4. Management


About Speaker:

Edwin Waldbusser retired from industry after 20
years in management of development of medical device products and development
of company Quality Systems. Products included IVD devices, kidney dialysis
systems and inhalation devices. QS experience includes design control, risk
analysis, CAPA, software validation, supplier qualification/ control and
manufacturing/ non-conforming product programs.

Edwin Waldbusser has a B.S. Mechanical
Engineering from NYU and a M.B.A from Drexel University. He is certified by
Lloyds of London as an ISO 9000 Lead Auditor and is a member of the Thomson
Reuters Expert Witness network. He has 5 issued patents.



Venue: Online

Speaker Name: Edwin Waldbusser

Price : $ 229

Thursday October 18 , 2018

EST 13:00

Duration : 60 Minutes

Email:support@compliancetrainingpanel.com



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