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

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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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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:

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California Designated Representative Training Courses

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• 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!
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The Best FDA CGMP Training

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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.

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

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      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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Wholesalers | 3PL | Reverse Distributors

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The Latest Activities Related To The DSCSA - FDA Website

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• 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

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

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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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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)

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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

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

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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

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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

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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

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Resuming Normal Drug and Biologics Manufacturing Operations During the COVID-19 Public Health Emergency - FDA Guidance

•  FDA GMP QSR cGMP Training - online training classes and courses

View the source FDA Guidance:  Resuming Normal Drug and Biologics Manufacturing Operations During the COVID-19 Public Health Emergency - Guidance for Industry (PDF)

According to the guidance:

"FDA is issuing this guidance to help drug and biological product manufacturers during the COVID-19 public health emergency plan and prioritize current good manufacturing practice (CGMP) activities as they transition from operations impacted by the public health emergency to normal manufacturing operations. This guidance describes how to evaluate and prioritize the remediation of CGMP activities that were necessarily delayed, reduced, or otherwise modified during the public health emergency in order to maintain production and the drug supply."

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Replacement of Title 21 CFR Part 820 with ISO 13485-2016 - Clarkston Consulting

• FDA cGMP QSR GMP Training - online training classes by SkillsPlus International Inc.

Read the full article:   Replacement of Title 21 CFR Part 820 with ISO 13485-2016 - Clarkston Consulting

According to the article:

"The FDA originally published a Notice of Proposed Rule Making (NPRN) in May 2018. The abstract from Regulation Identifier Number (RIN) 0910-AH99 states: “FDA intends to harmonize and modernize the Quality System regulation for medical devices. The revisions will update the existing requirements with the specifications of an international consensus standard for medical device manufactures, ISO 13485:2016. The revisions are intended to promote the use of more modern risk management principles and reduce regulatory burdens on device manufacturers and importers by harmonizing domestic and international requirements.” The NPRM is currently at the Proposed Rule Stage with an action date in October 2020. A panel committee meeting will be held after issuance of the proposed rule."

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FDA Launches the Digital Health Center of Excellence - FDA.gov

•  FDA cGMP QSR GMP Training - online training courses by SkillsPlus Intl Inc.

According to the FDA press release:

"Today, the U.S. Food and Drug Administration announced it is launching the Digital Health Center of Excellence within the Center for Devices and Radiological Health (CDRH). The launch of the Digital Health Center of Excellence is an important step in furthering the agency’s overarching dedication to the advancement of digital health technology, including mobile health devices, Software as a Medical Device (SaMD), wearables when used as a medical device, and technologies used to study medical products.

“Establishing the Digital Health Center of Excellence is part of the FDA’s work to ensure that the most cutting-edge digital health technologies are rapidly developed and reviewed in the U.S.,” said FDA Commissioner Stephen M. Hahn, M.D. “Today’s announcement marks the next stage in applying a comprehensive approach to digital health technology to realize its full potential to empower consumers to make better-informed decisions about their own health and provide new options for facilitating prevention, early diagnosis of life-threatening diseases, and management of chronic conditions outside of traditional care settings. The Digital Health Center of Excellence will provide centralized expertise and serve as a resource for digital health technologies and policy for digital health innovators, the public, and FDA staff.”"

Read the full press release: FDA Launches the Digital Health Center of Excellence - FDA.gov

Go to the: Digital Health Center of Excellence - FDA.gov

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Current Good Manufacturing Practice Training: A New Generation Series - CGMP Online Courses

In 8 one-hour segments learn what the experts know about the CGMPs for Pharmaceutical and Biotech manufacturing. 

Learn more, and view the details about CGMP Training: A New Generation Series

Ask yourself these three questions:

1. Do you need to conduct CGMP Training on a limited budget? 
2. Do you want employees to learn the CGMPs from an expert using real examples? 
3. Do you need CGMP Training resources suitable for multiple levels of the organization?

If you answered YES to any of these three questions then you should take a look at the courses below:

• 21CFR211 - Learn the highlights of the Current Good Manufacturing Practice Regulations.
• Your Personal Responsibilities - Part B. Review the requirements for personnel working in the pharmaceutical industry.
• Foundation to Facility - Part C. Dive into the requirements for the design, cleaning & maintenance of a facility.
• Maintaining Compliant Equipment Practices - Part D. Examine the requirements for the design, cleaning & maintenance of equipment.
• Supplier to Plant - Part E. Explore the requirements for the receipt, storage and use of all components.
• Plan to Production - Part F. Review the requirements for production process controls and validation.
• Plant to Patient - Part G, H, & K. Examine the requirements for packaging, labeling, warehousing and distribution.
• Laboratory to Release - Part I. Dive into the requirements for laboratory controls, method validation, stability and more!
• Proper Documentation Practices - Part J. Examine the requirements for proper paper and electronic documentation practices.

FDA GMP QSR cGMP Training - online training classes by SkillsPlus International Inc.

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Medical Device Shortages During the COVID-19 Public Health Emergency - FDA.gov

•  FDA cGMP QSR GMP Online Training Courses - presented by SkillsPlus International Inc.

According to the FDA article:

"One provision of this new statutory authority—section 506J(g) of the FD&C Act— requires the FDA to maintain a publicly-available, up-to-date list of the devices the FDA has determined to be in shortage. In addition, the FDA is providing a list of medical devices for which the FDA has been notified that manufacturing has been permanently discontinued. The list below fulfills this statutory obligation and reflects the categories of devices the FDA has determined to be in shortage at this time, and will be maintained and updated as the COVID-19 public health emergency evolves."

Read the full source article, and view the list:  Medical Device Shortages During the COVID-19 Public Health Emergency - FDA.gov

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FDA complicates 'chaotic' federal COVID-19 response with pledge to resume domestic inspections - Fierce Pharma

• FDA cGMP QSR GMP Online Training Courses - presented by SkillsPlus International Inc.

Read the full source article:

FDA complicates 'chaotic' federal COVID-19 response with pledge to resume domestic inspections - Fierce Pharma

According to the article:

"The FDA will resume "prioritized" domestic manufacturing inspections the week of July 20 after a four-month moratorium on most on-site walkthroughs, FDA Commissioner Stephen Hahn, M.D., said in a release Friday. 

However, a troubling uptick in new COVID-19 cases and deaths means the agency will weigh local virus activity when deciding which sites to inspect, and that fact had analysts questioning the FDA's announcement."

Read the FDA Statement, Coronavirus (COVID-19) Update: FDA prepares for resumption of domestic inspections with new risk assessment system - FDA.gov

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