CGMP Annual Refresher Training

The Regulations: 211.25 Personnel Qualifications

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CGMP Annual Refresher Training Made Easy!

“Each person engaged in the manufacture, processing, packing, or holding of a drug product shall have education, training, and experience, to enable that person to perform the assigned functions.” … “Training in current good manufacturing practice shall be conducted by qualified individuals on a continuing basis and with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them.”* In other words, you need Annual Refresher CGMP Training!

Topics offered by SkillsPlus International Inc. can be customized, therefore, to better meet your training needs. Here are some customizing features:

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So Easy Anyone Can Do It!
  • you select the standard presentation or specific subtopics within each of the Subparts addressed within the New Generation Series, in other words, you customize the content!
  • select the start date and the end date for training access, therefore, students schedule training at their convenience.
  • you set the passing grade requirement, so you know your employees have learned required information.
  • determine who, in addition to the student, will automatically receive a copy of the completion certificate for each student, so tracking your training documentation is easier.
  • if you need additional customizing for very unique plant site needs, let’s discuss what needs customizing and we can present to you a tailored quotation.

Email us or give us a call to discuss your training needs. Simply contact us!

CGMP Training: A New Generation
for annual refresher CGMP training


Image of the hierarchy of compliance from CGMPs: The New Generation Series.
Hierarchy of compliance from CGMPs: The New Generation Series.
  • 21 CFR 211: Pure, Safe and Effective
    – Overview of 21 CFR 211
  • Your Personal Responsibilities: Organization and Personnel
    – Detailed review of 21 CFR 211 – Subpart B
  • Foundation to Facility
    – Detailed review of 21 CFR 211 – Subpart C
  • Maintaining Compliant Equipment Practices
    – Detailed review of 21 CFR 211 – Subpart D
  • Supplier to Plant
    – Detailed review of 21 CFR 211 – Subpart E
  • Plan To Production
    – Detailed review of 21 CFR 211 – Subpart F
  • Plant To Patient
    – Detailed review of 21 CFR 211 – Subpart G, H, & K
  • Laboratory To Release
    – Detailed review of 21 CFR 211 – Subpart I
  • Proper Documentation Practices 
    – Detailed review of 21 CFR 211 – Subpart J
  • 21 CFR Part 820: Overview of QSR
    – Detailed review of 21 CFR 820 – Subpart A-O

Explore each topic above in more detail. Get ready for Annual Refresher CGMP Training!

Email us or give us a call to discuss your training needs. Simply contact us!

* Sec. 211.25 Personnel qualifications.