How Frequently Your Employees Must Be Trained in cGMP?

In this article, you will learn how frequently your employees must be trained as per FDA requirements.

What is the Frequency of Your Employees’ Training?

Many federal regulations and company policies require to comply with specific training schedules, control of approving trainees’ courses, view completion dates, test scores, and detailed information such as duration of actual training time or frequency.

In some cases, each company establishes its own frequency of employee training based on a risk assessment.

Based on this information, a recurrent training date or frequency can be generated, and if required, certificates of completion can be sent and stored in a trainee’s history in the Training Management System TMS.

As a rule of thumb, most companies bring training to their employees at least annually.

CIQA is a quality and regulatory consultant with 25 years of experience developing products and managing projects in the medical device supply chain, and pharmaceutical industries. His experience includes research, product development, operations management, manufacturing engineering, equipment design, regulatory affairs, and quality assurance. Specific questions about Document Control Management DCM or quality system training can be directed to CIQA at ramon.cayuela@ciqa.net.

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Three (3) Options to Create Document Control Management DCM Procedures:

Bronze Option. You Can Create Your Own Quality Procedures, using a Template.

You can download samples of the Document Control Management DCM procedure templates in .pdf format. 

To see the complete list of the most popular quality procedures templates, click here.

In addition, you can request a quotation to buy online a full SOP template document in MS Word format that is completely editable, ready to fill, and adapt to your specific needs.

Silver Option. We Can Bring You a Formal Training on how frequently your employees must be trained.

This option is recommended if you want to learn more about how to build robust quality system procedures. One of our expert(s) can provide online step-by-step training to your team (unlimited assistance) on how to build reliable SOPs using our template(s). Also, you can improve your corporate quality procedures and policies by incorporating our template(s) and tools.  It includes a fully editable template from the Bronze option, plus training, exams, and a training certificate for each assistant.  Request a quote now.

Gold Option. We Can Create Customized Quality Procedures.

One of our expert(s) will create and prepare your customized SOPs with the inputs and specific information of your company. It includes a fully editable template from the Bronze option, plus online support in document creation, implementation, and training. Request a quote online.

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REFERENCES:

For more information about how frequently your employees must be trained, refer to:

STATUTORY AND REGULATORY REQUIREMENTS

TITLE 21–FOOD AND DRUGS,

SUBCHAPTER C–DRUGS: GENERAL

PART 211 — CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS

Subpart B–Organization and Personnel

Sec. 211.25 Personnel qualifications.

httpss://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=211.25

TITLE 21–FOOD AND DRUGS

SUBCHAPTER H–MEDICAL DEVICES

PART 820 — QUALITY SYSTEM REGULATION

Subpart B–Quality System Requirements

Sec. 820.25 Personnel.

httpss://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=820.25

For more information about how frequently your employees must be trained, refer to:

httpss://www.fda.gov/industry