CPT301 – Cognition Cockpit Lead User 1

This course is designed to provide Cockpit Lead Users with a behind the scenes look into configuration. We will pull the curtains back and start to learn the early steps of altering Cockpit. This includes creating and modifying document and section formats, tables, attributes, trace matrices, views, reports, and more. The students will learn how libraries work and how to set up reusable repositories to pull from a common set of requirements, tests, or risks. There is significant hands-on work involving students entering data, creating traceability, creating new and modifying existing configurations (attributes, tables, traces, etc.), and creating document templates.

This course does not cover scripting, but rather focuses on configuring and tweaking of Cockpit to meet the customer’s needs.

In this session we will cover:

  • Review the template structure and navigation
  • Overview of Cockpit’s organizational structure
  • Tailoring the templates using configuration
  • Setting up reusable repositories

Prerequisites: CPT101

NOTE FOR REMOTE ATTENDEES: We will host a simultaneous screen sharing webcast for all remote attendees. Please make sure to have two computer monitors available: one to view and follow our screen share and one to follow along in your own Cockpit training environment. Look out for an email with links to register for the webcasts and to test your access to the remote Cockpit training environment as we get closer to training.

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Hourly Schedule

9:00 AM - 5:00 PM
Day 1
Review of CPT101 Topics
Cockpit Projects, Organization, and Site Levels
Document/Section Formats
Simple Configurations
Alternative Views
Ad Hoc Trace Tables
9:00 AM - 5:00 PM
Day 2
Reports
Document Templates
Project Templates
Tailoring the Risk Analysis
Reusable Libraries
History and Audit Log

Book Event

CPT301 – Cognition Cockpit Lead User 1 $1,700
Available Tickets: 18
The CPT301 – Cognition Cockpit Lead User 1 ticket is sold out. You can try another ticket or another date.

Date

Oct 23 2017 - Oct 24 2017

Time

Eastern Time
09:00 AM - 05:00 PM

Cost

$1,700

Location

Cognition Headquarters | Remote
24 Hartwell Avenue, Lexington, MA, United States
Category

Organizer

The Cockpit Crew
Phone
1-781-271-9300
Email
training@cognition.us
REGISTER
21 CFR 820.30(b): Design and Development Planning

"Each manufacturer shall establish and maintain plans that describe or reference the design and development activities and define responsibility for implementation. The plans shall identify and describe the interfaces with different groups or activities that provide, or result in, input to the design and development process. The plans shall be reviewed, updated, and approved as design and development evolves."

The Design Control Template provides a location for you to enter all this necessary information required by this subsection.
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21 CFR 820.30(i): Design Changes

"€œEach manufacturer shall establish and maintain procedures for the identification, documentation, validation or where appropriate verification, review, and approval of design changes before their implementation."

The Cockpit Platform facilitates design change in the design control process by providing an extensive Engineering Change Request feature as well as electronic signatures as part of configurable workflows. Cockpit is Part 11 compliant.
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21 CFR 820.30(j): Design History File

"€œEach manufacturer shall establish and maintain a DHF for each type of device. The DHF shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of this part."

The Design Control Template automatically creates multiple trace tables showing connections between parent and child requirements in the project. These trace tables can be exported to PDF, Word, or Excel and included as part of the Deisgn History File (DHF) submitted to FDA.
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21 CFR 820.30(c): Design Input

"€œEach manufacturer shall establish and maintain plans that describe or reference the design and development activities and define responsibility for implementation. The plans shall identify and describe the interfaces with different groups or activities that provide, or result in, input to the design and development process. The plans shall be reviewed, updated, and approved as design and development evolves."€

The Design Control Template provides a location for you to enter all this necessary information required by this subsection.
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21 CFR 820.30(d): Design Output

"Each manufacturer shall establish and maintain procedures for defining and documenting design output in terms that allow an adequate evaluation of conformance to design input requirements. Design output procedures shall contain or make reference to acceptance criteria and shall ensure that those design outputs that are essential for the proper functioning of the device are identified. Design output shall be documented, reviewed, and approved before release. The approval, including the date and signature of the individual(s) approving the output, shall be documented."

The Design Controls template provides a simple way for you to flow down from high level market requirements all the way down to design outputs. The Cockpit Platform makes creation and allocation of design outputs simple. Built-in trace matrices provide a top-level view of all connections made within the template.
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21 CFR 820.30(e): Design Review

"Each manufacturer shall establish and maintain procedures to ensure that formal documented reviews of the design results are planned and conducted at appropriate stages of the device's design development. The procedures shall ensure that participants at each design review include representatives of all functions concerned with the design stage being reviewed and an individual(s) who does not have direct responsibility for the design stage being reviewed, as well as any specialists needed. The results of a design review, including identification of the design, the date, and the individual(s) performing the review, shall be documented in the design history file (the DHF)."

Cockpit provides a comprehensive review feature, allowing you and your team to systematically review every aspect of your design control plan. Configurable workflow capabilities and Engineering Change Requests allow you more flexibility in how reviews are created and executed. Cockpit includes electronic signatures to maintain Part 11 compliance.
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21 CFR 820.30(h): Design Transfer

"Each manufacturer shall establish and maintain procedures to ensure that the device design is correctly translated into production specifications."

Cockpit facilitates design transfer by allowing you to export trace matrices and test results accumulated in the template out to PDF or Word. These documents can then be passed on to the next link in the supply chain.
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21 CFR 820.30(g): Design Validation

"Each manufacturer shall establish and maintain procedures for validating the device design. Design validation shall be performed under defined operating conditions on initial production units, lots, or batches, or their equivalents. Design validation shall ensure that devices conform to defined user needs and intended uses and shall include testing of production units under actual or simulated use conditions. Design validation shall include software validation and risk analysis, where appropriate. The results of the design validation, including identification of the design, method(s), the date, and the individual(s) performing the validation, shall be documented in the DHF."


The template provides an easy way for you to enter validation tests and allocate them to the appropriate User Needs. Test results can be marked and stored into the Cockpit database using simple UI commands. Full test results are easily exportable for use in regulatory submissions.
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21 CFR 820.30(f): Design Verification

"Each manufacturer shall establish and maintain procedures for verifying the device design. Design verification shall confirm that the design output meets the design input requirements. The results of the design verification, including identification of the design, method(s), the date, and the individual(s) performing the verification, shall be documented in the DHF."

Verification tests can be created for system requirements, device product requirements, subsytem requirements, and design outputs, or tests can be linked in from an external system using Cockpit's open API. All test execution steps and milestone-based results are stored within Cockpit'€™s powerful database.
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21 CFR 820.30(a): General:

"€œEach manufacturer of any class III or class II device, and [some] class I devices, shall establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met."

Not all devices are required to adhere to the Design Control standard. Those required to comply are specified in 820.30(a).
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