FDA Annual Training Toolkit

$1,790.00

This toolkit helps address the basics of compliance as dictated by regulatory authorities..  By learning CGMP, CGDP, and Data Integrity, any team can become familiar with the rules and requirements that can lead to successful management and development.

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CGDP Training

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 FDA’s 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

Download contains:

  • Training Quiz (.pdf, 2 pages)
  • Editable Training Quiz (.docx, 2 pages)
  • Training Quiz Answer Key (.pdf, 2 pages)
  • Editable Training Quiz Answer Key (.docx, 2 pages)
  • Training presentation (.pdf, 41 slides)
  • Editable Training Presentation (.pptx, 41 slides)
  • Training Attendance Sheet (.pdf, 1 page)
  • Editable Training Attendance Sheet (.docx, 1 page)

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CGMP Training

For the Spanish version of this training package, click here.

Do you know what can happen to a manufacturing facility and its employees if it is out of compliance with CGMP?

Companies that engage in the manufacture of pharmaceuticals, biopharmaceuticals, medical devices, and combination products must follow CGMP not only in commercial factories, but also in manufacturing for clinical trials, for clinical trials themselves, and for anything else that impacts a product that goes into a patient.

CGMP extend to compounding pharmacies as well, where a licensed pharmacist combines, mixes, or alters ingredients in response to a prescription to create a medication tailored to the medical needs of an individual patient.

This training package will help you increase your awareness of CGMP and comply with 21 CFR Part 211.

This product includes the following topics:

  • CGMP Basics
  • Regulations and Regulatory Agencies
  • Consistency of Regulations Worldwide
  • Major Elements of CGMP
  • Good Documentation Practices (GDP)
  • Linking CGMP and Compliance
  • Impact of Non-Compliance
  • Responsibility for CGMP

Download contains:

  • Training Quiz (.pdf, 2 pages)
  • Editable Training Quiz (.docx, 2 pages)
  • Training Quiz Answer Key (.pdf, 2 pages)
  • Editable Training Quiz Answer Key (.docx, 2 pages)
  • Training Presentation (.pdf, 42 slides)
  • Editable Training Presentation (.pptx, 42 slides)
  • Training Presentation Audio Recording (.mp4, 42 slides) Note:  To download just the recording with a quiz, answer key, and attendance sheet, click here.
  • Training Attendance Sheet (.pdf, 1 page)
  • Editable Training Attendance Sheet (.docx, 1 page)

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

Data Integrity Training

This package offers training on the basic principles of data integrity, including real case studies.

Topics include:

  • Types of Data
  • Data Transcription
  • 21 CFR Part 11 Compliance

Download contains:

  • Training Quiz (.pdf, 2 pages)
  • Editable Training Quiz (.docx, 2 pages)
  • Training Quiz Answer Key (.pdf, 2 pages)
  • Editable Training Quiz Answer Key (.pdf, 2 pages)
  • Training Presentation (.pdf, 28 slides)
  • Editable Training Presentation (.pptx, 28 slides)
  • Training Attendance Sheet (.pdf, 1 page)
  • Editable Training Attendance Sheet (.docx, 1 page)

The presentation also includes the examples of data integrity related observations in FDA Form-483s and Warning Letters.

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

SKU: TKS-02 Category: