California Designated Representative 3PL Training Course

• Buy now - California 3PL Designated Representative Training Course 
• People also buy these CA Des Rep Courses for:  Wholesalers | Reverse Distributors

California Designated Representative 3PL Training Course

Intended for California Designated Representative 3PL license applicants and their supervisors.
$525 per student - Buy now! - California Designated Representative 3PL Training Course

• 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 (accepted by the Board) by taking any one of our courses.
• Approved by the California State Board of Pharmacy. Covers all the required topics specified by the license application form.
• Online training classroom available 24 x 7
• More than 7,000 students have taken our state license-related courses

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California Designated Representative 3PL Training Course

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

• People also search for FDA CGMP online training classes provided by SkillsPlus Intl Inc.

Current Good Manufacturing Practice Training: A New Generation Series 
In 8 one-hour segments, learn what the experts know about the CGMPs for Pharmaceutical and Biotech manufacturing.

If you are visiting here, ask yourself these three questions:

• Do you need to conduct CGMP Training on a limited budget? 
• Do you want employees to learn the CGMPs from an expert using real examples? 
• 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.

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

Take action today!

• Learn more about our New Generation GMP online training series
• Call us:  (415) 948-5220

Recommendations About the Use of Dental Amalgam in Certain High-Risk Populations: FDA Safety Communication - FDA.org

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

Updated April 11, 2024

The original link broke.

You might also be interested in:

Dental Amalgam Fillings - FDA.gov

---  the original post follows below  --

Read the full FDA Safety Communication:  

Recommendations About the Use of Dental Amalgam in Certain High-Risk Populations: FDA Safety Communication - FDA.org

According to the communication:

"The U.S. Food and Drug Administration (FDA) is providing recommendations about the use of dental amalgam in certain groups of people who may be at greater risk to the potential adverse health effects of mercury exposure, to include:

• Pregnant women and their developing fetuses;
• Women who are planning to become pregnant;
• Nursing women and their newborns and infants;
• Children, especially those younger than six years of age;
• People with pre-existing neurological disease;
• People with impaired kidney function; and
• People with known heightened sensitivity (allergy) to mercury or other components of dental amalgam."

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

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FAQ: Where can I find California Board of Pharmacy Designated Representative training courses?

Here's the answer to the FAQ:  Where can I find California Board of Pharmacy Designated Representative training?

• Wholesaler Training Course
• 3PL Training Course
• Reverse Distributor Training Course

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California Board of Pharmacy Designated Representative Training Courses (by SkillsPlus Intl Inc.)

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
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FDA Warns Companies Illegally Selling Hangover Remedies - FDA.gov

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Read the full news release:  FDA Warns Companies Illegally Selling Hangover Remedies - FDA.gov

According to the article:

... "the U.S. Food and Drug Administration announced it has issued warning letters to seven companies for illegally selling unapproved products labeled as dietary supplements that claim to cure, treat, mitigate or prevent hangovers, in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The warning letters were issued to: Double Wood LLC; Ebnsol Inc.; Vita Heaven LLC (doing business as Hangover Heaven); Happy Hour Vitamins; LES Labs; Mind, Body & Coal LLC; and Purple Biosciences LLC."

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

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
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FDA Advances Work Related to Cannabidiol Products with Focus on Protecting Public Health, Providing Market Clarity - FDA.gov

• FDA GMP QSR cGMP online training courses taught by SkillsPlus International Inc.

According to the FDA Statement:

"Today, we are providing updates on our efforts in this area, including several new steps in areas of education, research and enforcement with the ultimate goal of continuing to protect the public health and working to provide market clarity."

Read the full FDA Statement:  FDA Advances Work Related to Cannabidiol Products with Focus on Protecting Public Health, Providing Market Clarity - FDA.gov

You might also be interested in:
FDA Finally Sends Overdue CBD Enforcement Update To Congress - Marijuana Moment

According to the Marijuana Moment article:

"While the process remains ongoing, the agency announced that it is actively exploring pathways to allow for the marketing of cannabidiol as a dietary supplement and is developing enforcement discretion guidance. It will also be reopening a public docket to solicit additional scientific information about the risk and benefits of the cannabis compound."

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FDA cGMP Training - online training courses by SkillsPlus International Inc.

FDA GMP Training - online training classes by SkillsPlus Intl Inc.

Benefits

• Use in the classroom as a training video
• Standardize content delivery
• Reduce training expense with our online learning pricing
• Use in one-on-one training environments
• Make these classes a part of corrective and preventive actions 

Details

• $50 per individual course 
• Once a course is purchased, you'll be able to view the course one-time (within 48 hours from the time of purchase). 
• Call us about Annual Global License pricing.
• Interested in a course? Give us a call:  (415) 948-5220

Courses Available

• 21 CFR 211: Pure, Safe, and Effective  - This program reviews 21 CFR 211 with the reminder that all these rules help us produce a product that is pure, safe and effective. This program is a must for new employee orientation training at all levels of the organization.
• Documentation Practices  - This program provides a most interesting review of proper documentation practices for both paper-based and electronic record environments. 
• Equipment and CGMPs - This topic discusses the requirements of 21 CFR211 Subpart D - Equipment, specifically the design and construction requirements for equipment including lubrication and coolants. The class addresses cleaning and maintenance requirements including automatic and electronic equipment. The class also covers the requirements for equipment identification, and required documentation.

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Retail Sales of Tobacco Products - FDA.gov

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

Read the full article:  Retail Sales of Tobacco Products - FDA.gov

"Note:
On December 20, 2019, the President signed legislation to amend the Federal Food, Drug, and Cosmetic Act, and raise the federal minimum age of sale of tobacco products from 18 to 21 years. It is now illegal for a retailer to sell any tobacco product – including cigarettes, cigars and e-cigarettes – to anyone under 21. FDA will provide additional details on this issue as they become available."

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

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
Designated Rep Certification Class
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Exemptee Certification Class
FL CDR Exam Prep
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FDA cGMP QSR GMP Online Training Courses by SkillsPlus International Inc.

• Recommended FDA CGMP online training courses and programs by SkillsPlus Intl Inc.

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

FDA cGMP QSR GMP Online Training

Benefits

• Use in the classroom as a training video
• Standardize content delivery
• Reduce training expense with our online learning pricing
• Use in one-on-one training environments
• Make these classes a part of corrective and preventive actions 

Details

• $50 per individual course 
• Once a course is purchased, you'll be able to view the course one-time (within 48 hours from the time of purchase). 
• Call us about Annual Global License pricing.

• Interested in a course? Give us a call:  (415) 948-5220

Courses Available

    View the details.

• 21 CFR 211: Pure, Safe and Effective - Subparts A-K  
• Your Personal Responsibilities - Subpart B  
• Foundation to Facilities - Subpart C  
• Maintaining Compliant Equipment Practices - Subpart D  
• Supplier to Plant - Subpart E
• Plant to Production - Subpart F
• Plant to Patient - Subpart G, H, & K
• Laboratory to Release - Subpart I
• Proper Documentation Practices - Subpart J

Senate confirms oncologist Stephen Hahn as FDA commissioner - The Washington Post

• FDA cGMP GMP online training courses by SkillsPlus International Inc.

Read the full article:  Senate confirms oncologist Stephen Hahn as FDA commissioner - The Washington Post

Texas doctor faces contentious issues as he assumes helm of sprawling agency

"Stephen Hahn, an oncologist and top official at MD Anderson Cancer Center, was confirmed Thursday as commissioner of the Food and Drug Administration. The Senate vote was 72 to 18.

Hahn, 59, takes over as the FDA juggles vexing political and health issues, including the Trump administration’s still-unresolved response to a surge in underage vaping over the past two years."

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Simple Ways To Prevent Falls In Older Adults - NPR.org

• FDA cGMP QSR GMP online training courses by SkillsPlus International Inc.

Read the full article:  Simple Ways To Prevent Falls In Older Adults - NPR.org

According to the article:

"What are some of the interventions you've used that can help seniors?

You can do so many things. First of all, I tell everybody you've got to do some balance training. Tai chi is probably the best exercise to prevent falls, but whatever works for you. And, interestingly, just walking does not reduce your risk for falling. So a lot of doctors will say, "Just get out and walk 20 minutes every day, and that'll keep you safe. That'll help you stay healthy." Walking is great for your heart; it's great for your brain; it's great for lots of it. But in order to really reduce your risk for falls, you've got to do something specific to balance."

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Health Fraud Scams (video) - FDA.gov

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

Health Fraud Scams (video) - FDA.gov

The FDA says, "Health fraud scams refer to products that claim to prevent, treat, or cure diseases or other health conditions, but are not proven safe and effective for those uses. Health fraud scams waste money and can lead to delays in getting proper diagnosis and treatment. They can also cause serious or even fatal injuries."

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FDA Conducts Anticipated Hearing on the Regulation of CBD Products - FrierLevitt.com

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

Read the full article:  FDA Conducts Anticipated Hearing on the Regulation of CBD Products - FrierLevitt.com

"At the hearing, Acting Commissioner Dr. Ned Sharpless delivered opening remarks and reiterated that recent changes to federal and state law, and the explosion of CBD products in the marketplace, have not affected FDA’s view that CBD cannot be lawfully added to any FDA-regulated consumer product. While the Agriculture Improvement Act of 2018 (the “Farm Bill”) generally legalized CBD derived from hemp (defined as cannabis with THC content below 0.3% by dry weight), the Farm Bill explicitly preserved FDA’s authority to regulate foods, drugs, dietary supplements and cosmetics containing CBD."

Still more to follow, as the entire country holds its breath on personal use and big business making huge money investments and gambles.

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

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
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Statement on FDA’s scientific work to understand per- and polyfluoroalkyl substances (PFAS) in food, and findings from recent FDA surveys - FDA.gov

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

Read the full article:  Statement on FDA’s scientific work to understand per- and polyfluoroalkyl substances (PFAS) in food, and findings from recent FDA surveys - FDA.gov

"PFAS are a family of human-made chemicals that are found in a wide range of products used by consumers and industry. There are nearly 5,000 types of PFAS, some of which have been more widely used and studied than others. Many PFAS are impermeable to grease, water and oil. For this reason, beginning in the 1940s, PFAS have been used for many different applications including in stain- and water-resistant fabrics and carpeting, cleaning products, paints and fire-fighting foams, as well as in limited, authorized uses in cookware and food packaging and processing, referred to as food contact substances."

" ... the FDA has been working to develop new methods to quantify certain per- and polyfluoroalkyl substances (PFAS) in foods. We have employed these new methods to test samples of foods Americans typically consume for certain types of PFAS, and today we are making available recently analyzed data from these initial testing initiatives.

Overall, our findings did not detect PFAS in the vast majority of the foods tested. In addition, based on the best available current science, the FDA does not have any indication that these substances are a human health concern, in other words a food safety risk in human food, at the levels found in this limited sampling. These data give our scientists a benchmark to use as we continue our critical work studying this emerging area of science."

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FDA cGMP QSR GMP Training Courses by SkillsPlus International Inc.

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
Designated Rep Certification Class
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SkillsPlus International Inc. Announces Online GMP e-Learning Courses

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

SkillsPlus International Inc. proudly announces  the reintroduction and updating of our very popular GMP e-learning courses. 

FDA cGMP QSR GMP Training Courses by SkillsPlus Intl Inc.

Do you need . . . ?

• New employee GMP training awareness that is quick and easy?
• Annual refresher training that is on a flexible schedule for team members?
• Training solutions that are responsive to a demanding production environment?

Our LMS GMP Training solution is the answer to your needs!

• A current list of topics is available.
• 24-7 Availability
• An ever growing list of topics is planned.
• Our pricing is structured for today’s tight budgets

Additional Features

• Private classrooms allow your company trainer to share notes to all your employees.
• Trainers can be identified as classroom monitors to tracking student grades and completion.

Online Courses Currently Available - and view the details

• 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.

Email us for a quote:  skillsplus@aol.com

FDA approves first two-drug complete regimen for HIV-infected patients who have never received antiretroviral treatment - FDA.gov

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

Read the full press release:

FDA approves first two-drug complete regimen for HIV-infected patients who have never received antiretroviral treatment - FDA.gov

The U.S. Food and Drug Administration . . .

"approved Dovato (dolutegravir and lamivudine), as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults with no antiretroviral treatment history and with no known or suspected substitutions associated with resistance to the individual components of Dovato. This is the first FDA-approved two-drug, fixed-dose, complete regimen for HIV-infected adults who have never received treatment for HIV. 

“Currently, the standard of care for patients who have never been treated is a three-drug regimen. With this approval, patients who have never been treated have the option of taking a two-drug regimen in a single tablet while eliminating additional toxicity and potential drug interactions from a third drug,” said Debra Birnkrant, M.D., Director of the Division of Antiviral Products. “Having a drug-sparing treatment available that uses fewer drugs is beneficial to patients who may have issues taking multiple medications over a long period of time.”"

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#FDA

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FDA plans first public hearings on legalizing CBD foods in April - CNBC

• cGMP FDA GMP Training Courses by SkillsPlus International Inc.

Read the full article:  FDA plans first public hearings on legalizing CBD foods in April - CNBC

"The Food and Drug Administration will hold its first public hearings on CBD in April as the agency weighs rules allowing companies to add the popular cannabis-based compound to food, Commissioner Scott Gottlieb said Wednesday. 

"We're deeply focused on this. We have taken on other hard challenges before," Gottlieb told the House Appropriations Committee on Wednesday. "You have my commitment I'm focused on this one.""

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Thrills and Pills: Another Top 5 Scary Pharma Flicks - Pharmaceutical Manufacturing

• FDA: QSR and cGMP Training Courses by SkillsPlus International Inc.

Read the full article:

Thrills and Pills: Another Top 5 Scary Pharma Flicks - Pharmaceutical Manufacturing

"It’s that time of year when watching a movie means snuggling up to a blood-curdling tale that will make you want to hide under the covers. And filmmakers love to tap into the collective fear of Big Pharma, bad medicines, and drug experiments gone horribly awry."

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FDA approves first autologous cellularized scaffold for the repair of cartilage defects of the knee - FDA.gov

Press Announcements > FDA approves first autologous cellularized scaffold for the repair of cartilage defects of the knee - FDA.gov:

"The U.S. Food and Drug Administration today approved Maci (autologous cultured chondrocytes on porcine collagen membrane) for the repair of symptomatic, full-thickness cartilage defects of the knee in adult patients. Maci is the first FDA-approved product that applies the process of tissue engineering to grow cells on scaffolds using healthy cartilage tissue from the patient’s own knee."

'via Blog this'


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GMP Training - FDA cGMP QSR GMP - Courses, classes, workshops, seminars

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2016 FDA Guidance Documents You Should Know | MDDI Medical Device and Diagnostic Industry News Products and Suppliers

View the annotated list:  2016 FDA Guidance Documents You Should Know | MDDI Medical Device and Diagnostic Industry News Products and Suppliers:

"This year FDA again issued several guidance documents that have substantial, positive implications for portfolio productivity and strategy. The following 2016 guidance documents merit careful consideration by every device manufacturer." . . .

'via Blog this'

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