Friday, August 9, 2019

California HMDR Exemptee Online Training Certification Class

California requires home medical device retailers (HMDR) to retain an on-site Exemptee  to conduct their business.  The Exemptee must be physically present during all hours of operation. This course is recommended by the California Department of Public Health as it meets the training requirements specified for HMDR Exemptee license applicants, and covers:
California HMDR Exemptee Online Training Certification Class. Earns a course completion certificate accepted by the California Department of Public Health - Food and Drug Branch. For home medical device retailers.
California HMDR Exemptee Training Class
  • State and Federal laws relating to the distribution of dangerous drugs and dangerous devices
  • State and Federal laws relating to the distribution of controlled substances
  • Knowledge and understanding of quality control systems
  • The United States Pharmacopoeia standards relating to the safe storage and handling of drugs
  • The safe storage and handling of home medical devices
  • Prescription terminology, abbreviations, and format

To meet the requirements, we offer a web-based, self-study class and the final exam for this certification. The class is fast, to the point, and has helped thousands of potential California Exemptees get licensed. More than 6,000 students have taken our state license-related training courses.

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California HMDR Exemptee Online Training Certification Class. Earns a course completion certificate accepted by the California Department of Public Health - Food and Drug Branch. For home medical device retailers.
California HMDR Exemptee Online Training Certification Class. Earns a course completion certificate accepted by the California Department of Public Health - Food and Drug Branch. For home medical device retailers.

SkillsPlus Intl Inc. - The Best GMP Training & cGMP Training Around
FDA cGMP QSR GMP Training Catalog & eBrochure - Courses, classes, workshops, and seminars
Free GMP Training Tips
Root Cause Analysis - GMP Training
Deviation Investigation Report Writing - GMP Training
Qualstar Simulation - Advanced GMP Training That's Fun!

 

Tuesday, July 23, 2019

FDA warns company marketing unapproved cannabidiol products with unsubstantiated claims - FDA.gov

Read the full news release:  FDA warns company marketing unapproved cannabidiol products with unsubstantiated claims to treat cancer, Alzheimer’s disease, opioid withdrawal, pain and pet anxiety - FDA.gov


Agency is expediting work to evaluate regulatory policies related to cannabis and cannabis-derived ingredients like CBD

According to the news release:
"... the U.S. Food and Drug Administration announced that it has issued a warning letter to Curaleaf Inc., of Wakefield, Massachusetts, for illegally selling unapproved products containing cannabidiol (CBD) online with unsubstantiated claims that the products treat cancer, Alzheimer’s disease, opioid withdrawal, pain and pet anxiety, among other conditions or diseases."  ... 
"The FDA has previously sent warning letters to other companies illegally selling CBD products that claimed to prevent, diagnose, treat, or cure serious diseases, such as cancer. Some of these products were in further violation of the Federal Food, Drug and Cosmetic Act because they were marketed as dietary supplements or because they involved the addition of CBD to food."

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FDA cGMP QSR GMP Training Catalog & eBrochure - Courses, classes, workshops, and seminars
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Qualstar Simulation - Advanced GMP Training That's Fun!

 

Friday, July 12, 2019

Report On The State Of Pharmaceutical Quality - FDA.gov


Center For Drug Evaluation And Research - Office Of Pharmaceutical Quality

Report On The State Of Pharmaceutical Quality - FDA.gov

Assuring quality medicines are available for the American public


The report is a good read.  It's data-rich, and provides a good overview.

This comes from the report's introduction:

"The Office of Pharmaceutical Quality (OPQ) in the Center for Drug Evaluation and Research (CDER) in the U.S. Food and Drug Administration (FDA) monitors the quality of CDER-regulated drugs legally marketed in the U.S. A quality drug is consistently safe and effective, free of contamination and defects. Patients and consumers expect quality drugs with every dose they take. The ‘State of Pharmaceutical Quality’ is a yearly snapshot of the pharmaceutical manufacturing industry’s ability to deliver quality pharmaceutical products."

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FDA cGMP QSR GMP Training Catalog & eBrochure - Courses, classes, workshops, and seminars
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Qualstar Simulation - Advanced GMP Training That's Fun!

 

Thursday, July 11, 2019

What You Need to Know (And What We’re Working to Find Out) About Products Containing Cannabis or Cannabis-derived Compounds, Including CBD - FDA.gov

Read the FDA article: What You Need to Know (And What We’re Working to Find Out) About Products Containing Cannabis or Cannabis-derived Compounds, Including CBD - FDA.gov


According to the FDA article:

"The FDA is committed to sound, science-based policy. The FDA is raising these safety, marketing and labeling concerns with you now because we want you to know what we know. We hope that you will provide any data that you have to the public docket.
Today’s Consumer Update includes a practical summary of what we know to date. As we learn more, our goal is to update you with the information you need to make smart choices about CBD products. Also, as the regulatory pathways are clarified we will take care to notify all stakeholders as quickly as possible.

Saturday, May 11, 2019

SkillsPlus International Inc. Announces Online GMP e-Learning Courses

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


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

  1. 21 CFR 211: Pure, Safe and Effective – An overview to of the Current Good Manufacturing Practice Regulation.
  2. Proper Documentation Practices – An explanation of the GDPs for paper and electronic records.
  3. Equipment – A review of equipment related GMPs.
  4. Root Cause Analysis – An in-depth examination of the most effective tools for investigation deviations. Individual deviation specific feedback and coaching is available.
  5. Investigation Report Writing – This course offers an in-depth examination of the FDA and QA expectations for writing a comprehensive investigation report. Individual report specific feedback and coaching is available.


Email us for a quote:  skillsplus@aol.com

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


Saturday, April 6, 2019

FDA & FTC Crack Down on CBD False Medical Claims - HealthcarePackaging.com

Read the full article:  FDA & FTC Crack Down on CBD False Medical Claims - HealthcarePackaging.com

"The FDA and FTC sent warning letters to three CBD companies making false claims about treating diseases like cancer and Alzheimer’s." 
"The letters claim the companies are falsely advertising the effectiveness of supplements to treat diseases including cancer, Alzheimer’s, fibromyalgia, and neuropsychiatric disorders. This marks the first time the FDA and FTC have issued a joint warning letter together."


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SkillsPlus Intl Inc. - The Best GMP Training & cGMP Training Around
FDA cGMP QSR GMP Training Catalog & eBrochure - Courses, classes, workshops, and seminars
Free GMP Training Tips
Root Cause Analysis - GMP Training
Deviation Investigation Report Writing - GMP Training
Qualstar Simulation - Advanced GMP Training That's Fun!

 

Friday, March 1, 2019

FDA Issues Guidance On Continuous Manufacturing

Quality Considerations for Continuous Manufacturing - Guidance for Industry


The guidance provides information regarding the FDA’s current thinking on the quality considerations for continuous manufacturing of small molecule, solid oral drug products that are regulated by the Center for Drug Evaluation and Research (CDER). The guidance describes several key quality considerations and provides recommendations for how applicants should address these considerations in new drug applications (NDAs), abbreviated new drug applications (ANDAs), and supplemental NDAs and ANDAs, for small molecule, solid oral drug products that are produced via a continuous manufacturing process. FDA supports the development and implementation of continuous manufacturing for drug substances and all finished dosage forms where appropriate, including those submitted in NDAs, ANDAs, drug master files (DMFs), biologics license applications (BLAs), and nonapplication over-the-counter (OTC) products. Scientific principles described in the guidance may also be applicable to continuous manufacturing technologies used for these drugs. However, the guidance is not intended to provide recommendations specific to continuous manufacturing technologies used for biological products under a BLA.

Source:  Quality Considerations for Continuous Manufacturing - FDA Guidance for Industry (PDF)

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SkillsPlus Intl Inc. - The Best GMP Training & cGMP Training Around
FDA cGMP QSR GMP Training Catalog & eBrochure - Courses, classes, workshops, and seminars
Free GMP Training Tips
Root Cause Analysis - GMP Training
Deviation Investigation Report Writing - GMP Training
Qualstar Simulation - Advanced GMP Training That's Fun!

 

Monday, February 11, 2019

FDA Signals Strengthening Regulation of Dietary Supplements - FDA.gov


Read the full press announcement:  Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s new efforts to strengthen regulation of dietary supplements by modernizing and reforming FDA’s oversight

Snippets from the FDA Commissioner's statement:
". . . we are announcing a new plan for policy advancements with the goal of implementing one of the most significant modernizations of dietary supplement regulation and oversight in more than 25 years.

As the popularity of supplements has grown, so have the number of entities marketing potentially dangerous products or making unproven or misleading claims about the health benefits they may deliver.

One of my top goals is ensuring that we achieve the right balance between preserving consumers’ access to lawful supplements, while still upholding our solemn obligation to protect the public from unsafe and unlawful products, and holding accountable those actors who are unable or unwilling to comply with the requirements of the law.

As part of our comprehensive efforts, today we sent 12 warning letters and five online advisory letters to companies  whose products, many of which are marketed as dietary supplements, are being illegally marketed as unapproved new drugs because the products bear unproven claims to prevent, treat or cure Alzheimer’s disease, as well as a number of other serious diseases and health conditions, including diabetes and cancer."


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SkillsPlus Intl Inc. - The Best GMP Training & cGMP Training Around
FDA cGMP QSR GMP Training Catalog & eBrochure - Courses, classes, workshops, and seminars
Free GMP Training Tips
Root Cause Analysis - GMP Training
Deviation Investigation Report Writing - GMP Training
Qualstar Simulation - Advanced GMP Training That's Fun!

 

Friday, December 28, 2018

FDA releases statement underlining their powers to manage a selection of cannabis products

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Read the entire press release:  FDA issues statement underlining their powers to manage a selection of cannabis products on FDA.gov


"Today, the Agriculture Improvement Act of 2018 was signed into law. Among other things, this new law changes certain federal authorities relating to the production and marketing of hemp, defined as cannabis (Cannabis sativa L.), and derivatives of cannabis with extremely low (less than 0.3 percent on a dry weight basis) concentrations of the psychoactive compound delta-9-tetrahydrocannabinol (THC). These changes include removing hemp from the Controlled Substances Act, which means that it will no longer be an illegal substance under federal law. 
Just as important for the FDA and our commitment to protect and promote the public health is what the law didn’t change: Congress explicitly preserved the agency’s current authority to regulate products containing cannabis or cannabis-derived compounds under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and section 351 of the Public Health Service Act. In doing so, Congress recognized the agency’s important public health role with respect to all the products it regulates. This allows the FDA to continue enforcing the law to protect patients and the public while also providing potential regulatory pathways for products containing cannabis and cannabis-derived compounds."

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SkillsPlus Intl Inc. - The Best GMP Training & cGMP Training Around
FDA cGMP QSR GMP Training Catalog & eBrochure - Courses, classes, workshops, and seminars
Free GMP Training Tips
Root Cause Analysis - GMP Training
Deviation Investigation Report Writing - GMP Training
Qualstar Simulation - Advanced GMP Training That's Fun!

 

Tuesday, December 25, 2018

As Partial Shutdown Continues, FDA Prepares To Furlough Employees - NPR.org

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Read the full article:   As Partial Shutdown Continues, FDA Prepares To Furlough Employees - NPR.org

"Although most of the agency's employees weren't working over the weekend and on Monday and Tuesday because of federal holidays, FDA will furlough some 40 percent of its staff starting Wednesday. 
However, much of the agency's workforce will continue through the shutdown, with more than 10,000 FDA employees — nearly 60 percent — reporting to work, according to numbers released by the agency Friday."

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SkillsPlus Intl Inc. - The Best GMP Training & cGMP Training Around
FDA cGMP QSR GMP Training Catalog & eBrochure - Courses, classes, workshops, and seminars
Free GMP Training Tips
Root Cause Analysis - GMP Training
Deviation Investigation Report Writing - GMP Training
Qualstar Simulation - Advanced GMP Training That's Fun!

 

Thursday, December 20, 2018

Data Integrity and Compliance With Drug CGMP Questions and Answers - FDA.gov

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Read the entire FDA guidance (pdf):  Data Integrity and Compliance With Drug CGMP Questions and Answers Guidance for Industry - FDA.gov

"In recent years, FDA has increasingly observed CGMP violations involving data integrity during CGMP inspections. This is troubling because ensuring data integrity is an important component of industry’s responsibility to ensure the safety, efficacy, and quality of drugs, and of FDA’s ability to protect the public health. These data integrity-related CGMP violations have led to numerous regulatory actions, including warning letters, import alerts, and consent decrees. The underlying premise in §§ 210.1 and 212.2 is that CGMP sets forth minimum requirements to assure that drugs meet the standards of the FD&C Act regarding safety, identity, strength, quality, and purity. Requirements with respect to data integrity in parts 211 and 212 include, among other things: . . . "

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FDA cGMP QSR GMP Training Catalog & eBrochure - Courses, classes, workshops, and seminars
Free GMP Training Tips
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Deviation Investigation Report Writing - GMP Training
Qualstar Simulation - Advanced GMP Training That's Fun!

 

Wednesday, October 10, 2018

Friday, October 5, 2018

FDA Released 3 DSCSA-Related Guidances - Healthcare Packaging

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Read the full article:   ICYMI: FDA Released Three DSCSA-Related Guidances - Healthcare Packaging

According to the article, the FDA released the following guidances:
  1. Product Identifiers Under the Drug Supply Chain Security Act- Questions and Answers Guidance for Industry (PDF)
  2. Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier (PDF)
  3. Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance Policy (PDF)

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California Designated Representative Training Courses (approved by the California State Board of Pharmacy)
California Designated Representative Training Courses (approved by the California State Board of Pharmacy) - Earn a training affidavit

For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):
     Florida:

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

Monday, August 13, 2018

GMP Trainer Awareness, Certification, and Master Trainer Certification Course

This online self-study course leads participants through many different ways to teach cGMPs and QSRs. Learn what a class instructor thinks while delivering a training session to students, so you can repeat that training approach in your own organization.
GMP Trainer Courses

How This Course Is Implemented


This course is implemented in three phases: Awareness, Certification, and Master Trainer.
  1. GMP Trainer Awareness - Students view presentations covering the course objectives below.
  2. GMP Trainer Certification - Students view the “Awareness” presentations. Students then prepare elements of a training session demonstrating the application of the content taught in the awareness course, or in some cases, capture and submit video segments of an actual or practice training session. All information submitted will be reviewed and critiqued by a team of Master Trainers. This course is taken simultaneously with the Awareness course.
  3. GMP Master Trainer - Learn GMP content to assure you know the basic GMP rules. This phase of the program is under development.
This is NOT a public seminar workshop. Our public seminar was so popular; we turned it into an online self-study course that fits into your busy schedule.


In this course, you will learn how to:

  • Apply a Participant Centered Approach to training
  • Write course objectives
  • Development a course assessment
  • Describe the difference between ice breakers and activities
  • Describe and develop ice breakers for a class
  • Describe and develop activities for a class
  • Explain the role of the instructor during activities
  • Develop an activity debriefing strategy
  • Describe various strategies for forming groups
  • Design a course presentation
  • Identify and demonstrate effective presentation skills
  • Develop stories for a class and how to deliver the story
  • Develop discussion questions
  • Develop and implement discussion follow-up strategies
  • Demonstrate the management of disruptive behavior
  • Identify the elements of a course assessment validation plan
  • Identify the elements of a course evaluation form
  • Develop a course evaluation form
Keywords:  #FDA #cGMP #GMP #QSR Train The Trainer T4T

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SkillsPlus Intl Inc. - The Best GMP Training & cGMP Training Around
FDA cGMP QSR GMP Training Catalog & eBrochure - Courses, classes, workshops, and seminars
Free GMP Training Tips
Root Cause Analysis - GMP Training
Deviation Investigation Report Writing - GMP Training
Qualstar Simulation - Advanced GMP Training That's Fun!