Coda Corp USA

Training Events

Please contact a Coda Corp USA representative to set up your training class

Name

Description

Attendees

Material

Demonstration of Control: Validation Concepts

This 2-day training class provides attendees a high level overview of the regulatory intent of the concept of validation as indicated by agency guidelines and findings.

Class notebook

A Brief History of Validation

This 2.5-day class reviews the validation regulations from their inception, including the predicate rule, supplement and expansions of the rule, Part 11 and significant agency and industry guidance documents. This class will provide attendees with present materials in cause and effect timelines that will illustrate the evolution of standard practices.

Class notebook

The Cradle to Grave Lifecycle: Validation, Revalidation and Change Control

This 5-day class will provide attendees with an understanding of the all the activities related to demonstrating and preserving process and system control. Topics covered will include: validation policies and procedures, validation plans and protocols, summary reports, commissioning and decommissioning documentation, and change control systems.

Class notebook

Conducting Vendor Audits

This 4-day class will provide attendees with an overview of quality vendor audit objectives. Training will also include exercises in auditor training, the categorization of vendor classes, methods of evaluating and documenting levels of acceptability and construction of supplier quality policies and procedures.

Class notebook

Conducting Part11 Assessments

This 4-day class will provide attendees with an in-depth overview of Part 11. The class will also include exercises in regulatory interpretation, methods of evaluating and documenting levels of acceptability and construction of assessment policies and procedures.

Class notebook; Part11 code and interpretive booklet

Software Analysis and Testing

This 5-day class will provide attendees with an overview of the approach to software analysis and testing. The class will include instruction in the areas of: Reading System Specifications, Analysis of Logic, Identification of Validation Targets and Test Design.

class notebook

Lifecycle Documents: Understanding and Using System Requirements and Specifications

This 5-day class will present on overview of User Requirements, Functional Requirements and Design Specifications. The class will review the intended purpose of the documents, vendor/customer responsibilities, the relationship of each document to the next and the relationship of lifecycle documents to validation testing. The class will offer instruction in both document generation and use.

class notebook

Printed Materials

Title

Description

Author

Part 11 Regulations and Interpretations

This booklet presents Part 11, and additional section with interpretive notes.

Gina Guido-Redden, CTO Coda Corp USA