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.

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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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FDA and OSHA Team Up to Publish Checklist to Assist Food Industry During COVID-19 | FDA .gov

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

According to the update:

"To assist the food industry as it navigates changes to operations related to COVID-19, the FDA has teamed up with OSHA to develop the “Employee Health and Food Safety Checklist for Human and Animal Food Operations During the COVID-19 Pandemic.” The checklist pulls from existing guidance provided by the FDA, CDC, and OSHA and serves as a quick reference to help the food industry assess employee health, social distancing, and food safety within workplaces as operations may be impacted by COVID-19. 

The checklist is broken into two distinct sections. The first section focuses on employee health, screening, and operation configuration for social distancing to prevent or minimize the spread of COVID-19 based on guidelines provided by CDC and OSHA. The second section highlights food safety requirements, found in existing regulations, that can help the food industry assess the potential impact of COVID-19-related operational changes on food safety practices. Some operational changes that could impact food safety include closures, changes among food safety staff, or changes to suppliers or ingredients."

Read the full source article: 
FDA and OSHA Team Up to Publish Checklist to Assist Food Industry During COVID-19 | FDA .gov

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

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
Designated Rep Certification Class
CA Designated Representative Training Program
California Designated Representative Training Program
California HMDR Exemptee Training
Exemptee Certification Class
FL CDR Exam Prep
SkillsPlus Intl Inc. - The Leader in Compliance Training
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FDA Warns Companies Illegally Selling Hangover Remedies - FDA.gov

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

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
Designated Rep Certification Class
CA Designated Representative Training Program
California Designated Representative Training Program
California HMDR Exemptee Training
Exemptee Certification Class
FL CDR Exam Prep
SkillsPlus Intl Inc. - The Leader in Compliance Training
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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

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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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SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
Designated Rep Certification Class
CA Designated Representative Training Program
California Designated Representative Training Program
California HMDR Exemptee Training
Exemptee Certification Class
FL CDR Exam Prep
SkillsPlus Intl Inc. - The Leader in Compliance Training
The Health, Drug, Prescription, and GMP Supersite Gift Store 

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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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

Not Recommended Internet Drug Sites - AWARxE

Read the full article & browse the list of sites: Not Recommended Sites - Safe Acquisition - Get Informed.® - AWARxE:

"Ordering drugs from these not recommended Web sites puts you and your family at risk.

Not Recommended Sites are those Internet drug outlets that appear to be out of compliance with state and federal laws or patient safety and pharmacy practice standards used by the National Association of Boards of Pharmacy® (NABP®). NABP has reviewed over 10,900 sites and found nearly 97% of those sites to be out of compliance."

'via Blog this'

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FDA Patient Network - What We Do

What We Do | Patient Network:

"You can use this Web site to learn more about how FDA works and how you can participate in the drug and medical device approval process."

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SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
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The Exemptee Institute
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FDA Changes Its Food Webpages

Updated June 26, 2024

The original links broke.

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New Era of Smarter Food Safety - FDA.gov

---  the original post follows below  ---

News & Events > Learn About the Changes to FDA.gov/Food:

"Welcome to FDA.gov/Food. If you have used this website before, you may have noticed that we’ve made some changes since your last visit. This page explains why we made changes to the Food section of FDA.gov. It also highlights the major changes so that you can quickly navigate to some of our most popular content.

• Why did you make changes to the Food section?
• What happened to some of the pages I used to frequent?
• What improvements have you made?
• What content has moved and where is it now?
• Have a question or suggestion?

'via Blog this'


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SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog

The Exemptee Institute
The Designated Representative Institute

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Select e-Learning That Is Pure, Safe and Effective

Watch out for PowerPoint slides full of nothing but text. Buy a book if that's what you want!

SkillsPlus International Info:

"Selecting an online e-Learning course is really rather simple.

1. Identify the course you really need. An Internet search is a great way to learn what is offered.
2. If they boast about being the least expensive, remember that you get what you pay for. The best business advice I ever got from one of my accountants was, never purchase cheap.
3. Compare the objectives of each course versus your requirements.
4. Call the vendor and ask if there is a handout. If not, begin to wonder if the vendor is afraid that the lesson content may not be accurate and not stand up to a critical review.
5. Ask to see a preview of the course. If they do not offer a free preview, question what they are hiding. Be concerned that you will be paying a lot of money to read a book on your computer screen.

Demand more!"

'via Blog this'

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Online Pharmacy Dangers Lurk

Beware, if you search for pharmacies online, there's a good chance you'll encounter infected websites, and rogue and illegal pharmacies: http://consumer.healthday.com/Article.asp?AID=655839

Homeland Security Cracks Down On Counterfeit Drugs

I'm glad to see that the Department of Homeland Security is stepping up efforts to combat counterfeit drugs, according to this news release, PhRMA Statement on Department of Homeland Security Efforts to Crack Down on Counterfeiting Crimes.

PhRMA states:  "The most common mechanism for counterfeit drugs to enter the U.S. drug supply is through purchases made on illegal online pharmacy sites that are operated by criminals in other countries with known counterfeiting problems. Cracking down on these illegal sites can help protect patient safety and help ensure that the closed U.S. drug supply system is not compromised."

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FDA Unapproved Drugs Initiative

There are prescription and over-the-counter (OTC) drugs marketed illegally without FDA approval. The manufacturers of drug products have not received FDA approval and do not conform to a monograph for making OTC drugs. These manufacturers circumvent the FDA approval process. The lack of evidence demonstrating that these unapproved drugs are safe and effective is a significant public health concern. The FDA has serious concerns that drugs marketed without required FDA approval may not meet modern standards for safety, effectiveness, quality, and labeling. Therefore, the FDA has crafted an entire suite of web pages that help manufacturers of unapproved drugs navigate the regulatory landscape, Unapproved Drugs: Drugs Marketed in the United States That Do Not Have Required FDA Approval. 

Here's what you can find: FDA's Concerns About Unapproved Drugs Background Information Unapproved Drugs Initiative Compliance Policy Guide Enforcement Actions Important Documents Publications Industry Information Unapproved Drug Decision Tree Unapproved Drugs Coordinator Letter to Branded Pharmaceutical Association Regarding Unapproved Drugs Coordinator Marketed Unapproved Drugs Workshop Required reporting of adverse events Health Care Professional Information Determining if a drug is FDA approved Orange Book NDC Directory http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/SelectedEnforcementActionsonUnapprovedDrugs/ssLINK/ucm119742.htm#drugsatfda Legal mechanisms to access unapproved drugs Reporting of adverse events Consumer Information But best of all, they offer a FDA WebLearn Course: Bringing an Unapproved Drug into Compliance. You can get a sense of the content by scanning the companion FDA's Bringing an Unapproved Drug into Compliance - Course Script (PDF). 

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Flu.gov Updated by HHS - New Resources Added

The government's Department of Health and Human Services (HHS) unveiled several new resources on the federal government's one-stop resource for flu information -- https://www.cdc.gov/flu/. Some of the new items include:

• A self-evaluation guide
• A myth and facts section

Stay well!

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FDA Website Redesigned

The FDA reports that "Through collaboration with users in testing site-wide designs, we made improvements to make FDA.gov easier and more satisfying to use." That may well be true as they describe their thinking on the redesign, About the FDA.gov Redesign - Why did FDA change its Website? Unfortunately, one unintended adverse effect impacts this blog. So, my apologies to folks who use and follow this blog . . . The FDA redesign has broken many links to FDA images, documents, and webpages. Here's to hoping they won't be redesigning the site again, any time soon. Peace.

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Asbestos.com - HONcode Certified

I've been doing a bunch of reading on mesothelioma and asbestos these days. It's hard to find balanced information. I often rely on the HONcode certification 'seal of approval' (principles) to help me discern more trusted sources of information. I mention this because I'm trying to find information sources that I think I can trust, such as Asbestos.com - The leading mesothelioma cancer resource. Do you rely on the HONcode? 

Related Posts: Reputable Mesothelioma Resources Are Nanoparticles Dangerous Like Asbestos? 

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Epidemic Teen Addiction To Prescription Drugs (video)

Updated December 31, 2020

The original link broke.

You might also be interested in:

Teenagers Abusing RX Drugs - CBS

- - -  original post follows below  - - -

It's shocking! Teens are finding it easier to obtain prescription drugs than alcohol, reports this MSNBC News Video, "Teens abusing prescription drugs." It turns out that the internet is a great teacher and source for obtaining prescription drugs without a prescription. I find this a very provocative video. What do you think? 

Previous Posts: Parents, Get A Clue About Teen Drug and Alcohol Abuse 

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