Showing posts with label training. Show all posts
Showing posts with label training. Show all posts

Tuesday, July 2, 2024

Popular cGMP Online Training Courses Updated

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.

Monday, August 1, 2022

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
  • 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.
    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!

About the Designated Representative 3PL License:

#CaliforniaDesRep #CaliforniaDesignatedRepresentative

Tuesday, April 26, 2022

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

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


Saturday, January 1, 2022

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:

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


Thursday, December 30, 2021

The Best FDA CGMP Training

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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Trusted FDA GMP Online Training Courses & Programs - Image of pharmaceutical glass containers
The Best FDA GMP Online Training Courses & Programs

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


Monday, December 13, 2021

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

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 Third-Party Logistics Providers (3PL). Image of backlit palm trees at sunset on a California ocean beach.
California Designated Representative Training Course For 3PL (third-party logistics providers).
Enroll now!

#CaliforniaDesRep #CaliforniaDesignatedRepresentative

Friday, November 19, 2021

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

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

#CaliforniaDesignatedRepresentative #CaliforniaDesRep


Saturday, November 13, 2021

Biden nominates Califf as FDA commissioner - RAPS.org

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

Wednesday, October 27, 2021

The Latest Activities Related To The DSCSA - FDA Website

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

Friday, October 15, 2021

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

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

Tuesday, September 28, 2021

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

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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Thursday, August 19, 2021

California Designated Representative Training Course

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.  Image of the Golden Gate Bridge.
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
California Board of Pharmacy; California State Board of Pharmacy; designated representative; approved; accepted; recognized; certified; training; affidavit; certificate; certification; program; course; class; webinar; seminar; workshop; event; license; application; form; online; web; eLearning; provider; vendor; seller; taught by; presented by; buy; purchase; enroll; register; wholesaler

Thursday, May 20, 2021

California Exemptee License Training - Closed Captioning

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


Tuesday, April 20, 2021

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

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!

 

Thursday, April 15, 2021

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

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!

 

Thursday, April 1, 2021

California Designated Representative 3PL Course

SkillsPlus International Inc. is the ONLY Board-approved provider of all three of the following online training programs.

Updated February 27, 2026:

California Designated Representative-3PL Training Course

If you are applying for a California Designated Representative 3PL license, then you’re also going to need to include proof of required training (specifically, a training affidavit) in your California Designated Representative-3PL license application packet. Earn a training affidavit by taking any of our California Designated Representative training courses.

About this online training course:

  • Price: $525 per student
  • 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, to include in your California Designated Representative 3PL license application.
  • Sign-Up Now! California Designated Representative 3PL online training course

 

California Designated Representative-3PL Training Course. Image of a glowing blue laptop against a dark background.
Register for this class, California Designated Representative-3PL Training Course.
Earns a training affidavit accepted by the California Board of Pharmacy.

Tuesday, March 2, 2021

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!

 

Wednesday, February 3, 2021

FDA names its first medical device cybersecurity director - Fierce Biotech

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

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

 

Thursday, January 28, 2021

Exemptee License Training - California Exemptee Certification

Exemptee License Training - California Exemptee Certification

An online training program for home medical device retailer Exemptee license applicants and their supervisors - California Exemptee License Training Certification Course - learn more & buy

California home medical device retail law requires companies carrying items needing a prescription to have an Exemptee (or pharmacist) responsible for the distribution of these items. In order to be in regulatory compliance, the company's Exemptee(s) must complete required training approved and accepted by the California Department of Public Health (CDPH) - Food and Drug Branch.

Such an Exemptee course is offered by SkillsPlus International Inc. and is recognized by the CDPH. Successful course completion earns a course completion certificate suitable for your Exemptee license application submission.

Details About Our California HMDR Exemptee Training Course

  • Learn more and buy now | California Exemptee Training
  • $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.
  • 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. 
  • Highly recommended, offered continuously since 2002.
Return to SkillsPlus International Info Blog - Home

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California HMDR Exemptee License Training. California Exemptee training certification course for home medical device retail license applicants and their managers. Recognized by the California Department of Public Health - Food and Drug Branch.
California HMDR Exemptee License Training. California Exemptee training certification course for home medical device retail license applicants and their managers. Recognized by the California Department of Public Health - Food and Drug Branch.