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

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

- - -

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 

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.

- - -

The Best FDA GMP Online Training Courses & Programs

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

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

- - -

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

Return to SkillsPlus International Info Blog - Home

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

Return to SkillsPlus International Info Blog - Home

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

Return to SkillsPlus International Info Blog - Home

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!

 

Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency | Guidance for Industry - FDA.gov

• People also search for FDA CGMP Online Training - respected FDA GMP online training courses provided by SkillsPlus International Inc. 

According to the guidance document:

"FDA plays a critical role in protecting the United States from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely guidance to support response efforts to this pandemic.

FDA is issuing this guidance to describe how we will request and conduct voluntary remote interactive evaluations at facilities where drugs are manufactured, processed, packed, or held; facilities covered under FDA's bioresearch monitoring (BIMO) program; and outsourcing facilities registered under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) for the duration of the COVID-19 public health emergency.

This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Secretary of Health and Human Services (HHS) on January 31, 2020, effective January 27, 2020, including any renewals made by the HHS Secretary in accordance with section 319(a)(2) of the Public Health Service Act (PHS Act) (42 U.S.C. 247d(a)(2))."

View the full source document: Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency Guidance for Industry - FDA.gov (PDF)

Return to SkillsPlus International Info Blog - Home

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!

 

Drug industry pushes FDA to solve growing inspection backlog - Politico

 AD - FDA GMP Online Training Courses by SkillsPlus Intl Inc. - AD

I had to read this snippet very carefully, and re-read it several times to make sure I completely understood the statistics reported. I suggest you do the same.

According to the article:

"From March through September, FDA inspected just three plants outside the U.S., well below the 600-plus it visited in each of the prior two years, the Government Accountability Office said last month. FDA has also struggled to keep up with inspections within U.S. borders, conducting just 52 during the same seven-month period last year, compared with roughly 400 each in 2019 and 2018."

Read the full source article: Drug industry pushes FDA to solve growing inspection backlog - Politico

Return to SkillsPlus International Info Blog - Home

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 names its first medical device cybersecurity director - Fierce Biotech

• FDA GMP QSR cGMP Online Training - recommended GMP online training courses offered by SkillsPlus International Inc. 

According to the article:

"The FDA has appointed its first medical device cybersecurity chief to help guide the agency’s regulatory strategies as more devices become interconnected—and potentially more vulnerable to digital attacks and breaches.

Kevin Fu, an associate professor and research fellow at the University of Michigan, was named to the post. He will serve a one-year term as an expert-in-residence at the agency’s Center for Devices and Radiological Health (CDRH) as well as at its nascent Digital Health Center of Excellence, which launched last fall."

Read the full source article:  FDA names its first medical device cybersecurity director - Fierce Biotech

Return to SkillsPlus International Info Blog - Home

-----

FDA GMP QSR cGMP Online Training - recommended GMP online training courses offered by SkillsPlus International Inc. 

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 Veteran Woodcock Being Considered to Lead Agency Under Biden - Bloomberg News

• 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 

According to the article:

"Janet Woodcock, a 30-year veteran of the Food and Drug Administration, is being considered by President-elect Joe Biden to serve as commissioner of the agency, according to people familiar with the selection process.

Woodcock is expected to serve as acting head of the drug regulator after Biden’s inauguration next week, while being vetted by the Biden team for the permanent job along with former FDA principal deputy commissioner Joshua Sharfstein, according to the people."

Read the full news article:  FDA Veteran Woodcock Being Considered to Lead Agency Under Biden - Bloomberg News

Return to SkillsPlus International Info Blog - Home

--------

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!

 

6 Things We Need From FDA Before Full 2023 DSCSA Enforcement - BioProcess Online

• California Designated Representative Training Courses | 3PL - Wholesaler - Reverse Distributor
• FDA GMP QSR cGMP Training - GMP online training courses

According to the article:

"The journey to industry compliance with the U.S. Drug Supply Chain Security Act (DSCSA) continues to twist and turn with recent requirements going into effect for distributors and dispenser and subsequent delays on enforcement of some of those requirements until Nov. 27, 2023."

"The discussions and perspectives in the meeting were often conflicting and sometimes seemed to ignore insights developed over the past years by several industry workgroups. We would like to suggest some concrete actions the FDA can take now to help bring together a complex and diverse number of sectors in advance of 2023 enforcement:"

Read the full source article:  6 Things We Need From FDA Before Full 2023 DSCSA Enforcement - BioProcess Online

Return to SkillsPlus International Info Blog - Home

------

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!

 

The 10 Best – And 10 Worst – Things You Can Do When FDA Inspects Your Firm - Medtech Insight

• FDA GMP QSR cGMP Online Training - popular GMP online training courses provided by SkillsPlus International Inc. 

According to the article:

"Executive Summary

From our archives: Despite the COVID-19 pandemic severely curtailing the US FDA’s ability to conduct on-site facility inspections, it’s still vitally important for manufacturers to remain audit-ready. In this collection of a 10-part Compliance Corner series, four longtime industry experts share evergreen advice on the best and worst things firms could do during an inspection."

Read the full source article:  The 10 Best – And 10 Worst – Things You Can Do When FDA Inspects Your Firm - Medtech Insight

Return to SkillsPlus International Info Blog - Home

---------

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 Picks New Target Date For Releasing Its Draft Harmonized Quality System Regulation - Medtech Insight

• FDA cGMP QSR GMP Online Training - respected GMP online training courses offered by SkillsPlus International Inc.

Updated March 4, 2021

FDA Misses Fifth Target Date For Issuing Draft Harmonized Quality System Reg - Medtech Insight

---  original post follows below  ---

According to the article:

"February 2021 is the latest target date selected by the US agency for releasing a draft of its retooled QSR, which has been undergoing a facelift for more than two years to harmonize it with international quality systems standard ISO 13485.  ...

This is the fifth in-house deadline the FDA has set for issuing its draft rule, which will harmonize the QSR with international quality systems standard ISO 13485:2016. The agency had previously set deadlines of April 2019, September 2019, April 2020 and October 2020."

Read the full article:  FDA Picks New Target Date For Releasing Its Draft Harmonized Quality System Regulation - Medtech Insight

Return to SkillsPlus International Info Blog - Home

-----------

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!