Saturday, April 25, 2020

Florida Certified Designated Representative (CDR) Training, Exam Prep, And More!


Over the years, we've fielded many questions revolving around the Florida Certified Designated Representative license.  Of chief interest, is how to go about preparing for the State of Florida Certified Designated Representative Laws & Rules Examination.

I've invited Dr. Sharon B. Roberts* (an expert in the regulatory realm of pharmaceuticals and wholesale drug distribution, and founder of CDR Resource Center) to share some thoughts and introduce the services that CDR Resource Center can provide:

  • Florida Certified Designated Representative (CDR) laws and rules examination preparation
  • Consulting expertise in prescription drug regulations and wholesale distribution compliance

Online Florida CDR Training By CDR Resource Center - Automated Online Training & Testing


All Prescription Drug Wholesale Distributors (including virtual BROKER -ONLY), companies that are seeking to do business in or with the State of Florida, are required to have a full-time Florida licensed Certified Designated Representative, (CDR). To become a FL licensed CDR a candidate must pass a laws and rules exam administered by the State of Florida.  CDR Resource Center has been training FL CDR candidates for over 12 years for the very difficult State exam.

Training for the State exam is offered in three ways:
  1. CDR Resource Center offers online virtual training allowing the candidate to study at their own pace from any computer.  The virtual training consists of 15 modules of educational and study materials, 100s of sample test questions and timed mock 40 question final exam. Register for FREE on our website - Try a quick FREE sample of the module style online training
  2. For the student who would prefer a live instructor, CDR Resource Center offers an 8 hour Webex with a live trainer.  The live training includes a bound law and rules manual, a pre-test, 7 hours of lecture and a post-test.   The live training can be purchased online in the Compliance Consulting section of the cdrresourcecenter.com
  3. For the candidate who has taken the State exam already and does not want to take a full course, we offer hourly consulting.  Bring us all your questions and purchase as much time as you’d like.  We can discuss your questions and point you to the correct answers. 

Additional CDR Resource Center Services


CDR Resource Center also provides state licensing support for the drug industry. Our company's licensing support services is unique to the industry allowing companies to pay as they go with no upfront onboarding fees or contracts


*About Our Guest Blogger - Sharon B. Roberts


Sharon Roberts, PharmD, JD, CDR
Sharon Roberts, PharmD, JD, CDR
Sharon Roberts, PharmD, JD, CDR has over 25 years in the Pharmaceutical industry as a Registered Pharmacist and practicing Florida lawyer. She then became licensed as a Certified Designated Representative (CDR) and worked for the Department of Business and Professional Regulation Drug, Device and Cosmetics Program of the State of Florida where she was a State Inspector/Drug Agent inspecting businesses involved in the manufacture, purchase, storage and sale of prescription and over-the-counter drugs, devices and cosmetics. As part of this experience she became intimately familiar with the Florida Drug, Device and Cosmetic Act. The contents of this Act are the basis of the studies required to become a State Certified Designated Representative (CDR). Combining all her experience, she founded CDR Resource Center which offers over 25+ years of experience in the regulatory realm of pharmaceuticals and wholesale drug distribution.

Wednesday, April 1, 2020

The Most Popular GMP Courses Taught By SkillsPlus International Inc.

SkillsPlus International Inc. was originally incorporated in 1991. While serving the needs of over 500 clients and customers world-wide, it is our mission to provide quality training and consulting services that meet the needs of the client organization.

Allan Dewes, President of SkillsPlus International Inc., possesses over 30 years experience in identifying training needs, and creating and delivering practical, cost-effective training solutions for CGMP, GCP, GLP, QSR, management, and supervisory development.  Mr. Dewes and his training team facilitate classes for all levels of the organization.  

What follows below is a small selection of our most popular cGMP training courses.


Root Cause Analysis & Deviation Investigation Report Writing


You asked for it, so we delivered!

The most popular class with Allan Dewes, "Root Cause Analysis and Investigation Report Writing" is now available as an online self-study course. In 3-1/2 hours you'll learn about the tools used to conduct a thorough deviation investigation. You'll also learn great tips and get clear guidance on how to write a deviation investigation report. This class is not just theory and offers clear examples. Private email-based coaching is also available.

Fees


About The Coaching Option (an advanced option) 


This optional purchase enables the student to practice each tool or report section. Each item is submitted to Allan for his review and evaluation. The student receives feedback. The purchase buys the student 4-hours of email-based coaching from Allan. Additional 4-hour blocks can be purchased if needed.

Questions?


Call us: (415) 948-5220


GMP Trainer Awareness, Certification, and Master Trainer Courses


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. 

How This Course Is Implemented


This course is implemented in three phases: Awareness, Certification, and Master Trainer. 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.

GMP Trainer Awareness – Students view presentations covering the course objectives below.

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.

GMP Master Trainer – Learn GMP content to assure you know the basic GMP rules. This phase of the program is under development.

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



GMP eLearning - Online  Courses


About Our Online Training Courses


  • $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 Currently 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.

Courses Coming Soon


  • Buildings and Facilities
  • Surviving an FDA Inspection
  • Understanding Validation
  • Contamination Control
  • Materials and CGMP
  • Organization and Personnel
  • Production and Process Control


Return to SkillsPlus International Info Blog - Home

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!

 

Saturday, March 21, 2020

California Designated Representative Courses

California Designated Representative

California Designated Representative Courses - for wholesalers, 3PL, reverse distributors

  • online training courses available 24 x7
  • approved by the California State Board of Pharmacy
  • 3 distinct courses for:  wholesalers, 3PL, reverse distributor
  • prices start at $525 per student
  • earns a training affidavit recognized by the Board
  • more than 6,000 students have taken our state license-related training programs
California Designated Representative Courses - for wholesalers, 3PL, reverse distributors
California Designated Representative Courses - for wholesalers, 3PL, reverse distributors

Thursday, March 19, 2020

Coronavirus (COVID-19) Update: FDA Focuses on Safety of Regulated Products While Scaling Back Domestic Inspections - FDA.gov

Read the full FDA Statement:  Coronavirus (COVID-19) Update: FDA Focuses on Safety of Regulated Products While Scaling Back Domestic Inspections - FDA.gov


In the statement:
"Today, we’re announcing that for the health and well-being of our staff and those who conduct inspections for the agency under contract at the state level, and because of industry concerns about visitors, we have temporarily postponed all domestic routine surveillance facility inspections. These are facility inspections the FDA traditionally conducts every few years based on a risk analysis. Importantly, all domestic for-cause inspection assignments will be evaluated and will proceed if mission-critical. We will continue to respond to natural disasters, outbreaks and other public health emergencies involving FDA-regulated products."

Return to SkillsPlus International Info Blog - Home

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, February 4, 2020

Exemptee Training - SkillsPlus Intl Inc

California HMDR Exemptee online training certification class

  • for home medical device retailers
  • $525 per student
Earns a course completion certificate accepted by the California Department of Public Health - Food and Drug Branch. Covers required topics specified in the Exemptee license application form.
"More than 6,000 students have taken our state license-related training programs."
— Allan Dewes - President of SkillsPlus International Inc.

California HMDR Exemptee online training certification class - $525 per student
California HMDR Exemptee online training certification class - $525 per student

Saturday, December 28, 2019

Friday, December 13, 2019

It's official: New FDA Commissioner Hahn wins Senate confirmation - FiercePharma

Read the full article:  It's official: New FDA Commissioner Hahn wins Senate confirmation - FiercePharma

According to the article:

"The FDA has been plenty busy without an official commissioner since former head Scott Gottlieb stepped down earlier this year, but now it has a new chief to take on the job.

Stephen Hahn, formerly chief medical officer of the University of Texas MD Anderson Cancer Center, secured confirmation from the Senate Thursday in a 72-18 vote, according to reports. He takes over the agency's sprawling brief, which covers pharmaceuticals, food safety, medical devices and tobacco."

Return to SkillsPlus International Info Blog - Home

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, 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.

Return to SkillsPlus International Info Blog - Home

--------------------

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."

Return to SkillsPlus International Info Blog - Home

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, 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."

Return to SkillsPlus International Info Blog - Home

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, 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."


Return to SkillsPlus International Info Blog - Home

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)

Return to SkillsPlus International Info Blog - Home

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."


Return to SkillsPlus International Info Blog - Home

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!