Saturday, July 11, 2020

Pharmaceutical Quality Resources Updated - FDA.gov

Pharmaceutical Quality Resources Updated - FDA.gov


The content on the FDA webpage mentioned above was recently updated.

It's a nice landing page of jump off points for most things related to quality.

If you need an overview:

"This  white paper provides additional background regarding OPQ and the FDA’s oversight of pharmaceutical quality."

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SkillsPlus Intl Inc. - The Best GMP Training & cGMP Training Around
Root Cause Analysis - GMP Training



 

Tuesday, July 7, 2020

Designated Representative License Application - California State Board of Pharmacy

Designated Representative - California Board of Pharmacy - License Application Forms

Here's where to find the Board's collection of California Designated Representative personal license application forms:
  • Wholesaler/Non-Resident Wholesaler
  • 3PL (third-party logistics provider)
  • Reverse Distributor

California Board of Pharmacy Designated Representative Training Course(s)

If you are applying for a California Designated Representative license, you're also going to need training specified by the Board.

A complete California Designated Representative license application consists of several forms and documents. The Board requires proof of training documentation, specifically, a training affidavit. A training affidavit is typically provided by a training company upon successful course completion.

Here's how to learn more and register for a Board-approved California Board of Pharmacy Designated Representative training course (wholesaler, 3PL, reverse distributor). Presented by SkillsPlus International Inc. Board approved. Earns a training affidavit accepted by the Board. Online course pricing starts from $525 per student.

Here's how to learn more and register for a Board-approved California Board of Pharmacy Designated Representative training course (wholesaler, 3PL, reverse distributor). Presented by SkillsPlus International Inc. Board approved. Earns a training affidavit accepted by the Board. Online course pricing starts from $525 per student.
Here's how to learn more and register for a Board-approved California Board of Pharmacy Designated Representative training course (wholesaler, 3PL, reverse distributor). Presented by SkillsPlus International Inc. Board approved. Earns a training affidavit accepted by the Board. Online course pricing starts from $525 per student.


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Saturday, April 25, 2020

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

Updated May 29, 2026

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


Photo of 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.

Pricing | Questions? - Call us (415) 948-5220


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.




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. 

Pricing | Questions? - Call us (415) 948-5220

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


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


Ask yourself these three questions:

  1. Do you need to conduct CGMP Training on a limited budget? 
  2. Do you want employees to learn the CGMPs from an expert using real examples? 
  3. 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.

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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!

 

Saturday, March 21, 2020

California Designated Representative Courses

Updated August 8, 2026

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
  • nearly 10,000 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."

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Tuesday, February 4, 2020

Exemptee Training - SkillsPlus Intl Inc

Updated May 27, 2026

California HMDR Exemptee online training certification class

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. 

If you are applying for a California Exemptee license, you'll need to include proof of required training in your license application. Take this online course to earn a course completion certificate accepted by the CDPH - include it in your license application.

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.
Nearly 10,000 students have taken our state license-related training programs.


California HMDR Exemptee online training certification class - $525 per student
California HMDR Exemptee online training certification class - $525 per student. No extra fees to retake quizzes.

Saturday, December 28, 2019

Retail Sales of Tobacco Products - FDA.gov

Updated August 22, 2026

You might also like: 

Tobacco Products:
https://www.fda.gov/tobacco-products

---  the original post follows below  ---

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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SkillsPlus Intl Inc. - The Best GMP Training & cGMP Training Around

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
Free GMP Training Tips
Root Cause Analysis - GMP Training
Deviation Investigation Report Writing - GMP Training
Qualstar Simulation - Advanced GMP Training That's Fun!