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Dana Senko
Compliance Manager
Kymanox

Current Good Documentation Practices (CGDP) Training Package

Satisfies FDA Annual Training Requirement
Product Description

Any company working in a CGMP (current Good Manufacturing Practices), CGLP (current Good Laboratory Practices), or CGCP (current Good Clinical Practices) setting is required to follow CGDP (current Good Documentation Practices) per 21 CFR Part 211.

FDA audits start with examination of documents and many of the FDAs observations and citations relate to documentation issues. This package will help your company to ensure that all employees are aware of CGDP and know how to follow them.

This product addresses the following key concepts:

  • CGDP Basics and Principles
  • Requirements
  • Quality Attributes
  • Guidelines for Correcting Errors
  • Electronic Records
  • Responsibility of CGDP
Watch a Video Description
Includes:   Free Starter Standard Pro
Purchase Price   $0 $99 $299 $499
Short Summary Presentation (4 slides) PDF yes yes yes yes
Training Presentation (40 slides) Powerpoint no yes yes yes
Editable Training Presentation (40 slides) Powerpoint no no no yes
Attendance Sheet Template (1 page) Word no yes yes yes
Quiz with Answer Key (4 pages) Word no no yes yes
Editable Quiz with Answer Key (4 pages) Word no no no yes
CGDP Examples (both Good and Poor) with Explanations (11 pages) PDF no no no yes
Optional 30 Minute Consultation with Subject Matter Expert (SME) Consultation no no no yes
Purchase
Return on Your Investment

Kymanox estimates that it would take a qualified contractor 120 hours (80+40) to complete the work included in this package.

This estimate is based on our extensive experience creating these and other templates and procedures, as well as averages that we have observed across the industry.

Please use the calculator at right if you would like to see how your own calculations affect the dollars and time saved by purchasing our package. You can replace the numbers for "Effort Hours to Complete" as well as "Labor Rate" in order to see differences.

Labor Rate is defined as the overall cost of one employee per hour (including pay rate and benefits), or the overall cost of one qualified contractor per hour. Kymanox estimates this at $60/hour for a qualified contractor.

Available Hours Per Day refers to the number of hours a single resource has to work on the project per day.  8 hours assumes that the resource is fully dedicated to the project.

   
   
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