FDA Rushed Out AI Tool

• The respected and recommended choice for FDA GMP QSR cGMP Online Training: FDA cGMP QSR GMP Online Training - popular online training courses by SkillsPlus International Inc. #FDA #cGMP #GMP #QSR #training | Recommended | Respected | Popular | The best choice for FDA CGMP online training courses and programs.

 According to the article:

"Under the Trump administration, the Food and Drug Administration is eagerly embracing artificial intelligence tools that staff members are reportedly calling rushed, buggy, overhyped, and inaccurate."

"FDA staffers who spoke with Stat news, meanwhile, called the tool "rushed" and said its capabilities were overinflated by officials, including Makary and those at the Department of Government Efficiency (DOGE), which was headed by controversial billionaire Elon Musk. In its current form, it should only be used for administrative tasks, not scientific ones, the staffers said."

Read the full source article:
https://arstechnica.com/health/2025/06/fda-rushed-out-agency-wide-ai-tool-its-not-going-well/

Popular cGMP Online Training Courses Updated

• The best and recommended choice for FDA GMP QSR cGMP Online Training: FDA cGMP QSR GMP Online Training - popular online training courses by SkillsPlus International Inc. #FDA #cGMP #GMP #QSR #training | Recommended | Respected | Popular | The best choice for FDA CGMP online training courses and programs.
  

Popular Training Classes Updated!

Our most popular cGMP online training programs have been updated: 1) 21 CFR 211: Pure, Safe and Effective – Overview of 21 CFR 211, and 2) Proper Documentation Practices – 21 CFR 211 – Subpart J. 

Here's what a recent student says, "Awesome! Great job with the new course, it is much easier to navigate, and has a much better look and feel to it!"

Learn more about these specific courses, and more, or contact Jennifer Payne - SkillsPlus International Inc. by email.

As Supply Chain Partners Ramp Up For November DSCSA Deadline, US FDA Gives Them Another Year - Pink Sheet

• The top choice for FDA GMP QSR cGMP Online Training: FDA cGMP QSR GMP Online Training - popular online training courses by SkillsPlus International Inc. #FDA #cGMP #GMP #QSR #training | Recommended | Respected | Popular | The best choice for FDA CGMP online training courses and programs. 

Read the full text of the source article, so you can be sure about what is included and excluded from the one year delay in enforcement action.

According to the article:

"The US Food and Drug Administration has given pharmaceutical distribution trading partners an extra year to comply with package-level Drug Supply Chain Security Act product tracing requirements that take effect 27 November [2023] before it starts enforcing them."

Source Article:  As Supply Chain Partners Ramp Up For November DSCSA Deadline, US FDA Gives Them Another Year -  Pink Sheet

Go to the FDA Guidance:  Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act--Compliance Policies - FDA.gov

California Designated Representative 3PL Training Course

• Learn more | Buy now! - California Designated Representative 3PL Training Course

California Designated Representative
3PL Training

Online training (approved by the California State Board of Pharmacy) for Designated Representative third-party logistics provider license applicants & their managers

If you are applying for a California Designated Representative license, then you’re also going to need to include proof of required training (specifically, a training affidavit) in your license application packet. Earn a training affidavit by taking any of our California Designated Representative training courses.

About this California Designated Representative 3PL training program

• Price:  $525 per student

• 

  Calif Des Rep 3PL Training

  Enter our online classroom to take the course. Available 24 x 7.
• This course is approved by the California State Board of Pharmacy.
• The course covers all required topics specified in the Board's license application.
• Successful course completion earns a training affidavit accepted by the Board.
• Nearly 10,000 students trained!

Take action!

Learn more  |  Buy now! 

About the Designated Representative 3PL License:

California Designated Representative 3PL License - California Board of Pharmacy

#CaliforniaDesRep #CaliforniaDesignatedRepresentative

DRUG FRAUD ALERT: DISTRIBUTOR/CUSTOMER PRODUCT ORDERING SCHEME

• Trusted Board-approved California Designated Representative online training programs for wholesaler, 3PL, and reverse distributor license applicants. Learn more & buy.

"Since December 2020, there have been reports of both distributors as well as several of their pharmacy customers receiving telephone calls and/or emails as part of a sophisticated “phishing” scam to unlawfully divert pharmaceutical goods in transit."

"RECOMMENDED ACTIONS TO PROTECT DISTRIBUTORS: RISK MITIGATION

There are several ways to validate correspondences with what appear to be legitimate distributor customers: ... "

Go to the following source document to view the complete list of recommended actions.

Source:   FRAUD ALERT: DISTRIBUTOR/CUSTOMER PRODUCT ORDERING SCHEME Version 2 (Updated June 2022) - HDAPCSC (PDF)

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For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):

• CA Designated Representative Wholesaler Training 
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training  
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute

Drug Products, Including Biological Products, that Contain Nanomaterials - Final Guidance Document

• Trusted FDA cGMP online training programs and courses by SkillsPlus International Inc.

According to the final guidance document: 

"Nanotechnology can be used in a broad array of FDA-regulated products, such as human drug products, including those that are biological products. Nanotechnology may be used to create drug products in which nanomaterials (as explained in section II of this document), serve a variety of functions, as active ingredient or inactive ingredients, including carriers loaded with an active ingredient. The inclusion of such materials may result in product attributes that differ from those of products that do not contain such materials, and thus may merit particular examination. This document provides guidance on the development of human drug products, including those that are biological products, in which a nanomaterial is present in the finished dosage form."

Reference:  Drug Products, Including Biological Products, that Contain Nanomaterials - Final Guidance for Industry - FDA.gov

Return to SkillsPlus International Info Blog - Home

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SkillsPlus Intl Inc. - The Best GMP Training & cGMP Training Around
Root Cause Analysis - GMP Training
Deviation Investigation Report Writing - GMP Training

FDA proposes to rate pharmaceutical manufacturing facilities - RAPS

• Trusted FDA cGMP online training programs and courses taught by SkillsPlus International Inc. 

According to the article:

"The US Food and Drug Administration’s (FDA) Office of Pharmaceutical Quality has proposed the development of a rating system to measure a firm’s quality management maturity (QMM)  as a way to mitigate drugs shortages and enhance the quality of finished drug products, according to a new white paper. The ratings would be publicly available."

Read the full source article: FDA proposes to rate pharmaceutical manufacturing facilities - RAPS

Go to the white paper referenced above, CENTER FOR DRUG EVALUATION AND RESEARCH (CDER) - An Office of Pharmaceutical Quality (OPQ) White Paper - Quality Management Maturity: Essential for Stable U.S. Supply Chains of Quality Pharmaceuticals 

California Designated Representative Training Courses

Start your new year training now!  SkillsPlus International Inc. is the ONLY Board-approved provider of all three (3) of the following training programs. Enroll now in any one of our Board-approved California Designated Representative training courses to earn a training affidavit for your license application:

• Wholesaler Training Course
• 3PL Training Course
• Reverse Distributor Training Course

California Designated Representative Training Courses

Don't get caught flat-footed in the new year! 

Nearly 10,000 Students Have Taken Our Courses!

Here's why our online training programs are so popular and highly recommended:

• These online training courses are designed for California Designated Representative license applicants and their managers. We make the messy regulatory requirements simple and easy to understand!
• Earn a Board-accepted training affidavit, for your license application, by taking any one of our courses.
• No need to schedule your training. Buy the course. Start when you’re ready! Therefore, buy now and start studying!
• Online internet-based e-learning, easily accessed to make it possible & convenient for you to study from your home or office, in other words, study in any location!
• Our courses involve more than just reading slides.
• Available 365 x 24 x 7. Come and go as needed. In other words, our courses are convenient and flexible.
• Composed of a series of self-study pre-recorded presentations that cover essential and required topics (as specified on their respective California Designated Representative license application form).
• Designed with a follow-up quiz after each course section. When you finish, you will request your completion documents, specifically, your training affidavit.
• We’ve added something new, closed captioning. Students can read what the course instructor is teaching. This feature helps ESL (English as a second language) students, and hard of hearing students. Therefore, our courses are more accessible.
• Offered continuously since 2002. Therefore, we have a long record of experience.

Don't get caught flat-footed in the new year! California Designated Representative online training courses by SkillsPlus International Inc.

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Keywords & Phrases:  wholesaler, 3PL, third-party logistics provider, reverse distributor, Board of Pharmacy, 2024, 2025, pharmacy law, rules and regulations, 2026

Jennifer Payne Named President Of SkillsPlus Intl Inc.

Jennifer Payne - President
SkillsPlus Intl Inc.

SkillsPlus International Inc. announces its new president (and owner), Jennifer Payne. She has been in the education field for 15 years. For the past 5 years, she has been responsible for: handling client California Designated Representative & Exemptee training documentation needs, assuring that program content reflects the most current regulatory requirements, the development & updates to content presentations & quizzes, and assisting with improving company procedures to streamline processes that ensure maximum customer service responsiveness. In her new role she also assumes responsibility for all administrative needs and for managing CGMP contract trainers.

Mrs. Payne earned a Bachelor Degree in Education with a minor in Spanish, and a Master of Education, both from the University of North Carolina at Greensboro. Similarly, her graduate research included: how psychology affects student learning; effective and reliable test construction; and statistical analyses of teaching techniques.

Allan Dewes, founder and outgoing president of SkillsPlus International Inc. says, "I founded SkillsPlus International Inc. thirty years ago. At that time, my goal was to provide quality and affordable training services to the pharmaceutical & allied industries. Now, my goal is to turn over the reins of the company to the next generation, promote a new vision, and reshape directions. I will remain a consultant to the president on technical & content issues, and advise on specific online course revisions as the need arises."

About SkillsPlus International Inc.

SkillsPlus International Inc., was incorporated in 1991. We offer training services to pharmaceutical & medical device manufacturers, California Designated Representatives, and California Home Medical Device Retailers & Exemptees.

For more information, visit: https://skillsplusinc.com/ 

Contact: https://skillsplusinc.com/contact-us/

The Best FDA CGMP Training

• Recommended FDA GMP online training courses and programs by SkillsPlus International Inc. 

Respected FDA GMP Online Training Courses & Programs

SkillsPlus International Inc., was incorporated in 1991. We offer training services to pharmaceutical and medical device manufacturers.

Initially, we offered live training at client plant sites. Consequently, we traveled all over the world teaching the CGMP regulations. Now as a result of high travel expenses, the risk of COVID-19 exposure, and demanding production schedules, we now only offer our CGMP training online. Our training courses with The GMP Professor are designed by course developers with over 40 years of CGMP experience. Furthermore, our company brings to those courses many commonly applied industry practices that may apply to your site as well.

Learn more about our basic and advanced GMP online training courses.

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The Best FDA GMP Online Training Courses & Programs

#FDA #CGMP #GMP best top choice place recommended respected trusted training