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

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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

Updated January 1, 2026

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, pharmacy law, rules and regulations, 2026, 2027, 2028

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

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California Designated Representative Training Course For 3PL (third-party logistics providers)

• Sign-up now! California Designated Representative training course for:
       3PL | Wholesalers | Reverse Distributors 

Updated May 27, 2026

California Designated Representative Training Course For Third-Party Logistics Providers (3PL)

The Designated Representative-3PL protects the public health and safety in the handling, storage, warehousing, distribution, and shipment of dangerous drugs and dangerous devices in the third-party logistics provider’s place of business.

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.

State-approved by the California State Board of Pharmacy. Nearly 10,000 students have taken one of our state license-related training classes!

This course covers all topics specified on the California Designated Representative 3PL license application form.

California Designated Representative Training Course For 3PL - Learn more >>

California Designated Representative Training Course For 3PL (third-party logistics providers).
Enroll now!

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Will Labor Requirements Increase in Meeting DSCSA Milestones? - HealthcarePackaging.com

• Recommended online training courses and programs:
• California Board-approved Designated Representative training for:
      Wholesalers | 3PL | Reverse Distributors
• FDA cGMP training by SkillsPlus International Inc. 

According to the article:

"With many companies either facing or concerned about labor shortages in manufacturing, an expert from Cardinal Health notes that outbound scanning alone may require a 12 to 15% increase in headcount in their operations."

... "she noted. “That outbound scanning is expected to increase labor by a minimum of 12 to 15% based on recent time studies. As an example, a distribution center with a 50-person night crew will need to hire six additional people just to support the outbound scanning.”"

Read the full source article:  Will Labor Requirements Increase in Meeting DSCSA Milestones? - HealthcarePackaging.com

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California Board-approved Designated Representative training for:
Wholesalers | 3PL | Reverse Distributors

#CaliforniaDesignatedRepresentative #CaliforniaDesRep

Biden nominates Califf as FDA commissioner - RAPS.org

• Respected FDA CGMP online training courses and programs by SkillsPlus International Inc.

Updated October 27, 2025

The links in the original post broke, and the post did not age well.

You might also like reading about the FDA Commissioner on the FDA website:

https://www.fda.gov/about-fda/fda-commissioner

---  the original post follows below  ---

According to the article:

"After months of speculation – and just days before a statutory deadline – President Joe Biden on Friday announced he would nominate Robert Califf to serve as Commissioner of Food and Drugs for the second time."

"Steven Grossman, executive director of the Alliance for a Stronger FDA, told Focus he expects Califf will enter the agency with a more pronounced mandate this time around and "act more resolutely" as a commissioner in the first year of a presidency, compared to his previous stint as commissioner in the final year of the Obama administration.

"I believe Dr. Califf’s priorities will have a common theme: FDA modernization. To achieve the greatest benefit for the American people, FDA needs the resources and tools to address acceleration of medical progress and the potential for a dramatically safer food supply. He will, I predict, advocate for data and technology modernization, improved means of recruiting and retaining FDA employees, facilities upgrades, and the means to make the agency’s processes more efficient, accurate, and responsive," Grossman said."

Read the full source article:  Biden nominates Califf as FDA commissioner - RAPS.org

Addendum: 
2022: U.S. Senate narrowly confirms Dr. Robert Califf to lead FDA for second time - Reuters

The Latest Activities Related To The DSCSA - FDA Website

• California Designated Representative training courses for: 
       Wholesalers | 3PL | Reverse Distributors
• Recommended FDA CGMP online training courses and programs by SkillsPlus International Inc. 

Latest Activity - Drug Supply Chain Security Act (DSCSA)

I like how the FDA is listing and reporting activity related to the DSCSA. They're now providing links to pertinent activities in a section called "Latest Activity."

According to the referenced FDA webpage:

"The Drug Quality and Security Act (DQSA), was enacted by Congress on November 27, 2013. Title II of DQSA, the Drug Supply Chain Security Act (DSCSA), outlines steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States. This will enhance FDA’s ability to help protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful. The system will also improve detection and removal of potentially dangerous drugs from the drug supply chain to protect U.S. consumers.

Additionally, the DSCSA directs FDA to establish national licensure standards for wholesale distributors and third-party logistics providers, and requires these entities report licensure and other information to FDA annually."

Go to:  Drug Supply Chain Security Act (DSCSA) - FDA.gov

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Former Obama FDA Chief Califf Is Front-Runner to Lead Agency - Bloomberg

• Respected FDA GMP online training courses and programs offered by SkillsPlus Intl Inc. 

According to the article:

"Robert Califf, who ran the U.S. Food and Drug Administration under President Barack Obama, has moved into top contention to lead the agency again, according to people familiar with the matter.

While a decision isn’t final, Califf is now the front-runner, said the people, who asked not to be identified because nothing has been announced. Califf, who is currently head of clinical strategy and policy at Alphabet Inc.’s Verily and Google Health units, would replace acting FDA Commissioner Janet Woodcock if he is confirmed by the Senate."

Read the full source article: Former Obama FDA Chief Califf Is Front-Runner to Lead Agency - Bloomberg