B107 - CAPA & Deviations

Overview

Covers materials that are essential to those individuals who are interested in learning Corrective and Preventive Actions (CAPA), Nonconforming Material Reports (NCMR) and Deviations associated with product, procedure and processes in any industries. Students will learn how to write and manage procedures, forms and how to avoid ISO audit and FDA inspection observations
Review ISO and FDA QSR CAPA, NCMR and Deviations regulations, definitions, types, and categories

CAPA, NCMR and Deviation management process

Activities associated with CAPA, NCMR and Deviation process

Learn how to write CAPA, NCMR and Deviation Procedure

Learn how to manage CAPA, NCMR and Deviation

Practice in writing CAPA, NCMR and Deviations

How to avoid ISO audit and FDA inspection observations

How to setup robust CAPA, NCMR and Deviation procedure and process and save organization money

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Instructor Bill Kurani

Instructor Bio

Mr. Bill Kurani has years of experience in product design, development, clinical trials, verification, validation, process validation & launch. Implemented Software Life Cycle based on IEC 62304, 60601, 61010, and GAMP and provided validation services

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Course Times

8:00 a.m - 5:00 p.m.

Lunch Break: 12:00 - 1:00 p.m.

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Course Details

Prerequisites: None

Hardware: N/A | Software: N/A

Required Materials:

- Proof of online Payment

- Pencil & Paper or laptop/tablet if you prefer

- If you are an ASQ member, a current-dated ASQ Membership ID

- Valid ID(s): sites may require US citizens to provide a Driver's License or a State-Issued ID; if you are not a US citizen you must bring 2 valid forms of identification

Learning Method: Lectures, teams, case studies, hands on approach, class discussions and examples

Class Time: 8 hours

Class Size: 25 max. participants

Facilities: Room with PC projector, whiteboard, etc.

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