GMP Trainers - Ensure That They Are Qualified Individuals

Updated March 14, 2021

You might also be interested in our online version of the course:

GMP Trainer Awareness, Certification, & Master Trainer Course. This online self-study course leads participants through many different ways to teach cGMPs and QSRs. Learn how your class instructor thinks about delivering a training session to students, so you can repeat that training approach in your own organization.

--- original post follows below  ---

GMP trainers must be "qualified individuals," according to 21 CFR 211 Subpart B.

Do you want to make sure your GMP trainers are qualified?

If you said yes, then consider this highly recommended course:

CGMP/QSR Trainer Certification Program - May 5-9, 2014 - Public Seminar in Fort Lauderdale, FL

Reference:  21 CFR 211 Subpart B:

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER C--DRUGS: GENERAL

PART 211 -- CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS

Subpart B--Organization and Personnel

Sec. 211.25 Personnel qualifications.

(a) Each person engaged in the manufacture, processing, packing, or holding of a drug product shall have education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions. Training shall be in the particular operations that the employee performs and in current good manufacturing practice (including the current good manufacturing practice regulations in this chapter and written procedures required by these regulations) as they relate to the employee's 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.

(b) Each person responsible for supervising the manufacture, processing, packing, or holding of a drug product shall have the education, training, and experience, or any combination thereof, to perform assigned functions in such a manner as to provide assurance that the drug product has the safety, identity, strength, quality, and purity that it purports or is represented to possess.

(c) There shall be an adequate number of qualified personnel to perform and supervise the manufacture, processing, packing, or holding of each drug product.

Make A New Year Resolution - Take A GMP Trainer Certification Course

Updated December 19, 2025

You might also be interested in the online distance learning version of our highly popular GMP Trainer Certification Course - taught by SkillsPlus International Inc:

GMP Trainer Awareness, Certification, and Master Trainer Courses

. This is NOT a public seminar workshop. Our public seminar was so popular we turned it into an online self-study course that fits into your busy schedule.

- - -   original post follows below   - - -

SkillsPlus Intl Inc.'s next public seminar of the highly popular GMP Trainer Certification Course is May 5-9, 2014 in Fort Lauderdale, FL.  Learn more: http://www.skillsplusinc.com/Pub_Sem.htm

This is a life-changing five-day class in which participants experience many different ways to teach CGMPs and QSRs. Learn what your instructor is thinking about during sessions, so that you can repeat that training approach in your organization.

Students make 2 presentations demonstrating their skills during the class. This class is suitable for food and dietary supplement manufacturers also.

1. Upon course completion, participants will be able to:
2. Explain the essentials of the CGMP/QSR regulations. 
3. Use the philosophical basis for the rules and interpretation to respond to CGMP/QSR related questions. 
4. Demonstrate techniques to present CGMP/QSR content in memorable ways.
5. Design and conduct activities that reinforcement learning. 
6. Facilitate discussions and questions like a pro. 
7. Respond to difficult questions.
8. Deal successfully with difficult students. 
9. Manage class room media. 

Return to SkillsPlus International Info Blog - Home
SkillsPlus Intl Inc. - The Best GMP & QSR Compliance Training Around

Dietary Supplement Firms Still Violating Basic Manufacturing Rules - NPI

Updated September 4, 2024

The original link broke.

You can still read about the same topic here, on Natural Products Insider:

https://www.naturalproductsinsider.com/manufacturing/fda-still-finds-basic-gmp-violations-in-supplement-industry

---  the original post follows below  ---

Dietary Supplement Firms Still Violating Basic Manufacturing Rules - Natural Products Insider:

"FDA has been bringing down the hammer on one out of three dietary supplement firms for failing to comply with cGMPs. Through the first several months of fiscal year 2013, of the 350 cGMP inspections FDA originally designated and concluded as falling under Part 111, the agency's 19 district offices collectively classified 33 percent, or 117 businesses, as OAI (official action indicated)."

Return to SkillsPlus International Info Blog - Home

SkillsPlus Intl Inc. - The Best GMP & QSR Compliance Training Around

Food or Dietary Supplement - Therapeutic Claims = Drugs

FDA Law Blog: Using Scientific Literature in Food or Dietary Supplement Marketing? Proceed with Caution:

"Recent actions by FDA and the FTC serve as reminders that both agencies will consider the use of scientific literature in determining whether marketing for a food or dietary supplement conveys disease treatment or prevention.

FDA recently issued a warning letter to a company that sells eye health dietary supplements. FDA alleged that the company’s website included “therapeutic claims” that established that its products were unapproved new drugs."

Return to SkillsPlus International Info Blog - Home

SkillsPlus Intl Inc. - The Best GMP & QSR Compliance Training Around

Enhance Your Training Skills - GMP & QSR Trainer Certification Course

Updated March 14, 2021

People think highly of this SkillsPlus International Inc. online training course:

GMP Trainer Awareness, Certification, & Master Trainer Course

---  original post follows below  ---

Sign-up soon!  Here's why . . .

1. The early registration discount expires April 15th.
2. This is the most popular trainer certification course on the market!

Don't delay, and save!  See you soon in warm and sunny Fort Lauderdale!

Overview:

This is a five-day public seminar that leads participants through many different ways to teach CGMPs and QSRs. Learn what your instructor is thinking about during sessions, so that you can repeat that training approach in your organization. Students make two presentations demonstrating their skills during the class. This class is also suitable for food and dietary supplement manufacturers.

Course Details:

• Learn how to train CGMPs and QSR courses from successful compliance professionals
• Experience, practice, and master the skills to make compliance training fun, informative, and exciting

Participants will learn how to:

• Explain the essentials of the CGMP/QSR regulations.
• Use the philosophical basis for the rules and interpretation to respond to CGMP/QSR related questions.
• Demonstrate techniques to present CGMP/QSR content in memorable ways.
• Design and conduct activities that reinforce learning.
• Facilitate discussions and questions like a pro.
• Respond to difficult questions.
• Deal successfully with difficult students.
• Manage classroom media

Return to SkillsPlus International Info Blog - Home

SkillsPlus Intl Inc. - The Best GMP & QSR Compliance Training Around