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

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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

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

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!

#CaliforniaDesRep #CaliforniaDesignatedRepresentative

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

SkillsPlus International Inc. - The leader in compliance training.
Learn more about our online training courses and programs.

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

Halloween Safety Tips: Costumes, Candy, and Colored Contact Lenses - FDA.gov

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

According to the FDA: 

"Enjoy a safe and happy Halloween by following these guidelines.

Halloween is fast approaching, and you and your kids may be celebrating it a bit differently this year. Whatever form your celebration takes, make sure it includes safe hygiene practices such as covering your mouth and nose with a cloth face covering or mask when around others, maintaining social distance and frequent hand washing.  The Centers for Disease Control also have tips for protecting yourself and others.

Whether you’re a ghost or zombie, vampire or witch, poor costume choices—including decorative (colored) contact lenses and flammable costumes—and face paint allergies can cause injuries that haunt you long after Halloween.

Enjoy a safe and happy Halloween by following these guidelines from FDA, the Consumer Product Safety Commission, and the Centers for Disease Control and Prevention:" ...

Source Article:  Halloween Safety Tips: Costumes, Candy, and Colored Contact Lenses - FDA.gov

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California Designated Representative Training Course

• Register now for California Board of Pharmacy Designated Representative Wholesaler Training Course - presented by SkillsPlus International Inc. - $525 per student. Board Approved. 
• People also enroll in these California Designated Representative courses for:
        3PL (third-party logistics providers) | Reverse Distributors

Designated Representative - Wholesaler License - California State Board of Pharmacy

According to the Board, "To be licensed as a Designated Representative in California, you must satisfy the requirements under Business and Professions Code section 4053. Wholesale operations that distribute dangerous drugs or dangerous devices must be supervised by a registered pharmacist or an individual approved by the board as a designated representative. These companies may not operate unless the pharmacist or designated representative is physically on the licensed premises. To ensure proper control at all times, the board recommends that there be more than one person approved to supervise operations."

Download the Designated Representative - Wholesaler License Application Form - California State Board of Pharmacy

California Board of Pharmacy Designated Representative Wholesaler Training Course 

If you are applying for a California Designated Representative Wholesaler license, then you’re also going to need to include proof of required training in your license application packet.

The proof of required training is a form called the training affidavit. You can earn a training affidavit by taking a California Designated Representative training course approved by the Board.

Learn more and purchase this California Board of Pharmacy Designated Representative Wholesaler Training Course — presented by SkillsPlus International Inc.

• This course is approved by the California Board of Pharmacy.
• Designed specifically for drug/device wholesalers
• Successful class completion earns a training affidavit accepted by the Board, to include in your Designated Representative license application.
• More than 7,000 students have taken our courses
• SkillsPlus International Inc. has deep experience, offering a Designated Representative training course continuously (without interruption) since 2002.
• Our online courses run on popular devices and operating systems.

Learn more and buy California Board of Pharmacy Designated Representative Wholesaler Training Course - presented by SkillsPlus International Inc. - $525 per student. Board Approved. 

Keywords and Phrases
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California Exemptee License Training - Closed Captioning

• Purchase now to take this online class, California HMDR Exemptee license training certification course

Closed Captioning Added To Our Exemptee Training Course

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. 

About Our California Exemptee License Training Certification Course

• $525 per student. No extra fees to retake any of the quizzes.
• Recognized by the CDPH.  By the way, the Exemptee license application asks, "Have you completed training program(s) that address the following: (Attach copy of completed training certificate) …"
• This course covers all topics specified in the license application.
• The online classroom is open 24 x 7 for your convenience. Come and go as needed.

California home medical device retail laws require that companies carrying items needing a prescription have Exemptees (or pharmacists) responsible for the distribution of these items. For regulatory compliance, a company's Exemptee(s) must complete training recognized by the California Department of Public Health (CDPH), Food and Drug Branch.

This Exemptee course is offered by SkillsPlus International Inc. and is approved and accepted by the CDPH. Successful course completion earns a course completion certificate that you will include in your Exemptee license application. 

Give us a call if you have any questions:  (415) 948-5220

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Purchase now to take this online class, California HMDR Exemptee license training certification course

U.S. FDA Outlines Inspection and Assessment Activities - Precision Vaccinations .com

• People also ask about FDA CGMP Online Training - recommended FDA GMP online training courses provided by SkillsPlus International Inc.

According to the article:

"The U.S. Food and Drug Administration issued a new report titled “Resiliency Roadmap for FDA Inspectional Oversight,” outlining the agency’s inspectional activities during the COVID-19 pandemic.

Its detailed plan to move toward a more consistent state of operations, including the FDA’s priorities related to this work going forward."

Read the full source article:  U.S. FDA Outlines Inspection and Assessment Activities - Precision Vaccinations.com

Read the report here:  Resiliency Roadmap for FDA Inspectional Oversight - FDA.gov

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SkillsPlus Intl Inc. - The Best GMP Training & cGMP Training Around
Free GMP Training Tips
Root Cause Analysis - GMP Training
Deviation Investigation Report Writing - GMP Training
Qualstar Simulation - Advanced GMP Training That's Fun!

 

FDA overdue on guidance as DSCSA deadline looms - RAPS.org

• People also recommend this: FDA CGMP Online Training - trusted FDA GMP online training courses offered by SkillsPlus International Inc. 
• State-approved California Designated Representative training courses for:  wholesalers | 3PL
  

According to the article:

"Legal experts advised the pharmaceutical industry to start preparing now to meet the November 2023 deadline for having fully electronic interoperable systems in place for tracking  products through the supply chain under the Drug Supply Chain Security Act (DSCSA).

Food and drug law attorneys outlined ways the industry can meet these requirements at a 15 April traceability forum on DSCSA implementation sponsored by the Healthcare Distributors Association (HDA)."

Read the full source article:  FDA overdue on guidance as DSCSA deadline looms - RAPS.org

You might also be interested in:  Drug Supply Chain Security Act Law and Policies - FDA.gov

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SkillsPlus Intl Inc. - The Best GMP Training & cGMP Training Around
Free GMP Training Tips
Root Cause Analysis - GMP Training
Deviation Investigation Report Writing - GMP Training
Qualstar Simulation - Advanced GMP Training That's Fun!