CGxP Writing Toolkit

$2,000.00

The CGxP Writing Toolkit is a comprehensive suite of trainings, SOPs, templates, and exercises to help any organization ensure that they are using proper standards and techniques necessary to produce accurate, compliant documents with FDA diction.

Do the documentation and writing standards at your company help or hinder you and your company’s long-term success?

In a CGxP environment, high-quality documents ultimately are the most valuable contribution individuals can make to their company’s long-term success. Documents record the past (e.g., batch records, investigation reports), instruct the present (e.g., SOPs), and direct the future (e.g., project plans).

Therefore, authors need to constantly strive to follow best practices for CGxP writing to maximize their investment of time and energy for the following reasons:

  • To meet regulatory requirements.
  • To effectively record and share current information, knowledge, and understanding that can be reliably and confidently leveraged in the future.
  • To provide a strong foundation for related documents.

This toolkit provides CGxP documentation and writing standards that can be customized to fit any organization.

Use our ROI Calculator to see how much time and money can be saved by purchasing this product!

CGxP Document Writing - Workshop Exercise 1

This download provides an exercise to improve CGxP document writing.

Download contains:

  • An example of bad documentation writing (.pdf, 7 pages)
  • Editable example of bad documentation writing (.docx, 7 pages)
  • Corrected example/Answer key for bad documentation writing example (.pdf, 12 pages)
  • Editable corrected example/answer key for bad documentation writing example (.docx, 12 pages)

Use our ROI Calculator to see how much time and money can be saved by purchasing this product!

CGxP Document Writing - Workshop Exercise 2

A helpful writing exercise in which you improve an investigation memorandum.

Download contains:

  • An example of bad memorandum writing (.pdf, 3 pages)
  • Editable example of bad memorandum writing (.docx, 3 pages)
  • Corrected example/Answer key for bad memorandum writing example (.pdf, 4 pages)
  • Editable corrected example/answer key for bad memorandum writing example (.docx, 4 pages)

Use our ROI Calculator to see how much time and money can be saved by purchasing this product!

CGxP Document Writing - Workshop Exercise 3

This helpful exercise will teach you proper signatory format. It is a great tool for people that must sign and edit documents properly.  This exercise stresses the importance of CGMP and CGDP.

Download contains:

  • An example of bad CGMP/CGDP writing (.pdf, 4 pages)
  • Corrected example/Answer key for bad CGMP/CGDP writing example (.pdf, 7 pages)
  • Editable corrected example/answer key for CGMP/CGDP writing example (.docx, 7 pages)

Use our ROI Calculator to see how much time and money can be saved by purchasing this product!

CGxP Document Writing - Workshop Agenda

This product is an agenda for a one-day workshop on writing CGxP documents that can be used to structure training.

Download contains:

  • Document Writing Workshop Agenda (.pdf, 1 page)
  • Editable Document Writing Workshop Agenda (.docx, 1 page)

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Training Presentation CGxP Formatting Standards

This PowerPoint presentation covering the formatting standards of CGxP documents contains an abundance of valuable information on how to properly write for FDA and associated audiences. Training focuses on SOP/technical report/memorandum standards, file naming, and Microsoft Word tools.

Download contains:

  • CGxP Formatting Standards Training Presentation (.pdf, 31 slides)
  • Editable CGxP Formatting Standards Training Presentation (.pptx, 31 slides)
  • Editable Training Attendance Sheet Template (.docx, 1 page)

Use our ROI Calculator to see how much time and money can be saved by purchasing this product!

Training Presentation CGxP Writing Style and Standards

This PowerPoint presentation provides a training resource that provides personnel key information needed to write clearly and properly, to include CGxP terminology, high impact language, three core CGxP writing attributes, the writing process, as well as small writing exercises.

Download contains:

  • CGxP Writing Style and Standards Presentation (.pdf, 23 slides)
  • Editable CGxP Writing Style and Standards Presentation (.pptx, 23 slides)
  • Editable Training Attendance Sheet Template (.docx, 1 page)

Use our ROI Calculator to see how much time and money can be saved by purchasing this product!

CGxP Formatting Standards SOP

The formatting standards SOP provides valuable information on how to format various documents, how to name files, how to use proper abbreviations, and gives standards for writing memorandums. This procedure outlines the best practices for formatting and utilizing Microsoft Word to author CGxP technical reports, SOPs, and memorandums used to support global regulatory compliance.

Download contains:

  • Formatting Standards SOP (.pdf, 20 pages)
  • Editable Formatting Standards SOP (.docx, 20 pages)

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CGxP Writing Style and Standards SOP

This valuable document provides instructions on how to use high impact language while you are writing official documents and includes standard terminology and abbreviations. This procedure outlines the best practices for writing CGxP technical reports, SOPs, and memorandums used to support global regulatory compliance. The procedure conveys the importance of writing effectively and includes instructions for using high impact language to write documents that are correct, objective, consistent, logical, direct, and concise.

Download contains:

  • Writing Style and Standards SOP (.pdf, 14 pages)
  • Editable Writing Style and Standards SOP (.docx, 14 pages)

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Memorandum Template

This product is a key reference that provides a template for writing proper memorandums.

Download contains:

  • Memorandum Template (.pdf, 1 page)
  • Editable Memorandum Template (.docx, 1 page)

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Procedure and Template for writing SOPs and Technical Reports

This template and it's procedural contents outline how to write standard operating procedures (SOPs) and technical reports.

Download contains:

  • Procedure and Template for writing SOPs and Technical Reports (.pdf, 14 pages)
  • Editable Procedure and Template for writing SOPs and Technical Reports (.docx, 14 pages)

Use our ROI Calculator to see how much time and money can be saved by purchasing this product!

SKU: TKS-04 Category: