Make A New Year Resolution - Take A GMP Trainer Certification Course

Updated December 19, 2025

You might also be interested in the online distance learning version of our highly popular GMP Trainer Certification Course - taught by SkillsPlus International Inc:

GMP Trainer Awareness, Certification, and Master Trainer Courses

. 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.

- - -   original post follows below   - - -

SkillsPlus Intl Inc.'s next public seminar of the highly popular GMP Trainer Certification Course is May 5-9, 2014 in Fort Lauderdale, FL.  Learn more: http://www.skillsplusinc.com/Pub_Sem.htm

This is a life-changing five-day class in which participants experience many different ways to teach CGMPs and QSRs. Learn what your instructor is thinking about during sessions, so that you can repeat that training approach in your organization.

Students make 2 presentations demonstrating their skills during the class. This class is suitable for food and dietary supplement manufacturers also.

1. Upon course completion, participants will be able to:
2. Explain the essentials of the CGMP/QSR regulations. 
3. Use the philosophical basis for the rules and interpretation to respond to CGMP/QSR related questions. 
4. Demonstrate techniques to present CGMP/QSR content in memorable ways.
5. Design and conduct activities that reinforcement learning. 
6. Facilitate discussions and questions like a pro. 
7. Respond to difficult questions.
8. Deal successfully with difficult students. 
9. Manage class room media. 

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FDA Issues Final Guidance on Mobile Medical Apps | Medical Connectivity

• Trusted FDA CGMP online training courses provided by SkillsPlus International Inc.

FDA Issues Final Guidance on Mobile Medical Apps | Medical Connectivity:

"In this final guidance, FDA has chosen to use two factors to distinguish between mobile medical apps that are low risk that they do not intend to regulate, and higher risk apps that will be regulated. FDA will regulate those mobile medical apps intended:

• to be used as an accessory to a regulated medical device; or
• to transform a mobile platform into a regulated medical device."

You might also be interested in:
Mobile Medical Applications - FDA Guidance for Industry and Food and Drug Administration Staff (PDF - 269KB)

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Unique Device Identification (UDI) System - FDA Final Rule

Press Announcements > FDA finalizes new system to identify medical devices:

" . . . the U.S. Food and Drug Administration announced a final rule for the unique device identification system (UDI) that, once implemented, will provide a consistent way to identify medical devices.

The UDI system has the potential to improve the quality of information in medical device adverse events reports, which will help the FDA identify product problems more quickly, better target recalls, and improve patient safety. The FDA has worked closely with industry, the clinical community and patient and consumer groups in the development of this rule."

Follow this link to view the Unique Device Identification System - Final Rule (PDF)

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Exemptee Training - HME DME - Meets CDPH HMDR Requirements

California HMDR Exemptee Training Certification Course  
Buy now - SkillsPlus International Inc.'s California Exemptee Training Course is accepted by the California Department of Public Health (Food & Drug Branch)

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. 

 

The HMDR Exemptee Plays A Vital Role:

• In order to dispense prescription (Rx) devices from your HMDR (Home Medical Device Retailer) facility you must employ either a licensed pharmacist, or a licensed HMDR Exemptee. For a description of HMDR Exemptee requirements, refer to the California Health and Safety Code, Division 104, Part 5, Section 111656.4 (a).

Background:

• A HMDR facility is defined as any area, place, or premises [other than a licensed pharmacy] in and from which prescription (Rx) devices, home medical devices, or home medical device services are stored, sold, fitted, or dispensed pursuant to a prescription at retail.
• A HMDR warehouse is owned by the HMDR facility and is a separate place where prescription (Rx) home medical devices are stored and transported to the firm's existing licensed HMDR facility (NOT direct to patients’ homes). There may not be any fitting, display, or sales at this facility. The warehouse is used for storage only.
• An individual may submit an application for an Exemptee license on their own behalf or a licensed HMDR operator may submit an Exemptee license application for a current employee for the purpose of dispensing prescription medical devices from that particular facility. In either case, the applicant must meet the required knowledge and training mandated by California Health and Safety Code, Division 104, Part 5, Section 111656.4 (a). This law requires one year of work experience in a facility where dangerous drugs and/or dangerous devices are dispensed, evidence of high school graduation or GED equivalent, and evidence that the applicant has completed a training course that addresses areas of HMDR knowledge and training.
• The HMDR Law can be found in the California Health and Safety Code, Sections 111656 through 111656.13 of the Sherman Food, Drug, and Cosmetic Law

Visit the HMDR Program Website for the most current information.

You might also be interested in:

• California Exemptee HMDR and DME Providers Certification Course - this course meets the "training course" requirement mentioned above
• The Exemptee Institute

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FDA - Hurricane Preparedness Free Tips

Updated April 24, 2024

You can still read about the same topic here:

Hurricanes: Health and Safety - FDA.gov

---  the original link broke  ---

Be safe, be prepared. Follow the link below to the FDA's tips on hurricane preparedness.

Public Health Focus > Hurricane Safety Checklist:

"The FDA reminds consumers to take precautions for storing water and ensuring the safety of their food and medical supplies for themselves, their families, and their pets during and after any hurricane-related rain, possible flooding and power outages.

The agency also reminds consumers that it is important to have a plan in place for emergency medication and medical supplies for both people and animals. This is especially true for those with health concerns, particularly if the power goes out.

In general, FDA encourages consumers to: . . . "

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2013 Plan For FDA CDRH Guidance Documents

The CDRH is considering developing a variety of guidance documents in fiscal year 2013. Specific topics and status as final and draft guidance document, are provided in the two lists:

---

Prioritized medical device guidance documents that the Agency intends to publish in FY 2013 ("A-list")

Final Guidance Topics

• Refuse to Accept (RTA) Policy for 510(k) Submissions
• Acceptance and Filing Review for Premarket Approval Applications
• Investigational Device Exemptions (IDE) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies
• In Vitro Companion Diagnostic Devices
• Design Considerations for Pivotal Clinical Investigations for Medical Devices
• De Novo Classification Process (Evaluation of Automatic Class III Designation)
• The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications
• CDRH Appeals Processes
• Medical Device Classification Product Codes
• The Pre-Submission Program and Meetings with FDA Staff
• Mobile Medical Applications
• eCopy
• Premarket Notification [510(k)] Submissions for Medical Devices that Include Antimicrobial Agents

Draft Guidance Topics

• Distinguishing and Reporting Medical Device Recalls from Product Enhancements
• Types of Communication During the Review of Medical Device Submissions
• FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations
• eCopy
• Appropriate Use of Voluntary Consensus Standards in Premarket Submissions

---

Device guidance documents that the Agency intends to publish, as the Agency’s guidance-development resources permit each in FY 2013 ("B-list")

Final Guidance Topics

• Finalizing existing draft guidance documents.

Draft Guidance Topics

• Benefit-Risk Determinations in Premarket Notifications (510(k)s)
• Direct to Consumer (DTC) Genetic Testing: IVDs
• Transfer of Ownership of a Premarket Notification (510(k)) - Questions and Answers
• Custom Devices

Reference:  FDA CDRH Fiscal Year 2013 (FY 2013) Proposed Guidance Development

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GHTF Archives Can Be Found On The IMDRF Website

• FDA cGMP QSR GMP Online Training Courses

"The Global Harmonization Task Force (GHTF), the global medical device harmonization body no longer exists. The GHTF has been permanently replaced by the IMDRF (International Medical Device Regulators Forum), a successor organization comprised of officials from regulatory agencies around the world. The GHTF website no longer exists. Fortunately, the GHTF Archives are now housed on the IMDRF website. These archives (follow the hyperlink below) should be considered historic information, no longer current, and therefore, should not be acted upon.

http://www.imdrf.org/ghtf/ghtf-archives.asp "

'via Blog this'

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Regulators, Industry Discuss Potential Impact of IMDRF

• FDA cGMP QSR GMP Online Training Courses

Updated June 16, 2023

The original link broke.

You might also be interested in:

International Medical Device Regulators Forum (IMDRF) - FDA.gov

---  the original post follows below  ---

The International Medical Device Regulators Forum (IMDRF) may be the newest global harmonization body.

Regulators, Industry Discuss Potential Impact of IMDRF > RAPS > News - Article View:

"Unlike GHTF, which was a blend of agency regulators and industry representatives, IMDRF relegates industry to a consultation role while keeping regulators in the drivers' seat. "After 20 years, time for a change," said Minor

This desire for accelerated change is written into the agency's mission, observed Trautman, speaking to the session by video link after an East Coast hurricane prevented her from attending in person. "The mission of the IMDRF is to strategically accelerate international medical device regulatory convergence to promote an efficient and effective regulatory model for medical devices that is responsive to emerging challenges in the sector while protecting and maximizing public health and safety," she relayed, quoting its mission statement."

'via Blog this'


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Consider On-Site Training - Popular GMP Classes and QSR Courses

Updated March 10, 2021

Given the COVID-19 pandemic, you might also be interested in CGMP online training:

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

- - -

Comprehensive master training plans often take advantage of a 'blended' training approach . That is, a mixture of multiple training modalities, including online training and live instructor-led classes.

As 2013 approaches, you might want to consider and/or justify bringing in SkillsPlus Intl Inc. to deliver your on-site in-person training classes.

Learn more about SkillsPlus Intl Inc On-Site QSR Classes & GMP Training Courses

Consider these features and benefits of live, on-site, in-person training.

Convenient, Flexible, & Interactive 

• You get to pick the date, time, & location – adjust for shifts, or number of days that works best for your employees; select your facility, plant, training center, or other desired location 
• In-person training engages students – with the right instructor on-site training encourages interaction according to class size and level of training, ensures consistent messages, and fosters team building 

Content That Fits Your Needs 

• Your training needs are addressed - training content & activities are adjusted, based on students’ prerequisite & current skill levels, and the organization’s specific needs, objectives, issues, and challenges. Tailoring the content ensures that training is unique & relevant. 
• Confidential issues can be covered - Training on-site means you can candidly discuss your organization's unique challenges and opportunities. Sensitive company information can be shared by participants and used as concrete examples during interactive and workshop sessions in complete confidence. 

Great Value 

• Avoid having to leave the building - Without ever leaving the building, staff can gain new skills, boost their confidence, and improve their productivity. Since on-site training takes place at client’s premises, there is no travel, no time away from the plant, and no unrelated expenses that are often associated with public courses (e.g. travel, hotel, subsistence, etc.). 
• You get live in-person expert instruction! The best on-site teachers are skilled facilitators and/or consultants. With the right instructor, you get the added advantage of getting expert advice alongside the training.

You won't be disappointed by selecting SkillsPlus Intl Inc. to deliver your on-site training. Our past students say that they love our interactive style, learn a lot that they can put into immediate use, and recommend us to their industry friends.

Learn more about SkillsPlus Intl Inc On-Site QSR Classes & GMP Training Courses

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Olympics for Medical Device Manufacturers - Onsite QSR Training Class

This class gets students engaged, energized, and so excited that they'll be up out of their seats!

Olympics for Medical Device Manufacturers - Onsite QSR Training by SkillsPlus International Inc.

This course takes QSRs to a deeper level of understanding through a series of challenging activities. Past students would say this training is fun!  This instructor led class is taught on-site in-house at client plant locations.

By the end of class, students will be able to:
1. List the hottest issues in QSR compliance.
2. Locate items of interest in 21CFR820.
3. Explain the 21CFR211 rationale for specific 483 observations.
4. Demonstrate knowledge of common CGMP practices and details.
5. State the consequences of not following QSR.

For more information, visit:
Olympics for Medical Device Manufacturers - Onsite QSR Training by SkillsPlus International Inc.

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Essentials for Medical Device Manufacturers - QSR training class

Updated June 5, 2025

This specific course is no longer offered.

You might also be interested in these online training programs:

https://skillsplusinc.com/cbpresent.htm

---  the original post follows below  ---

In this original or refresher training, experience fun learning the regulations.

Essentials for Medical Device Manufacturers by SkillsPlus International Inc. is an instructor-led training class, taught on-site in-house at client plant locations.  This is useful as a new employee basics course, and can be used as a refresher course.

Purpose:
This class teaches employees how to identify the essential elements of QSR for beginning work in the medical device industry.

Objectives:
Upon class completion, students will be able to . . .
1. State the historical development of QSR regulations.
2. Explain the role and function of standard operating procedures.
3. Describe the personal role for contamination control.
4. Identify the sources of contamination.
5. List the common QSR documentation practices.
6. Explain material controls.
7. State the common practices of production and process controls.
8. Explain the importance of an adequate, appropriate, and sufficient building design.
9. State the requirements of equipment design and construction.
10. List the requirements for building, and equipment cleaning and maintenance.
11. Explain the role of the quality management system.
12. Explain the role of the laboratory.

Topics:

• Heard on the street
• Past, present, and future
• Legal issues
• Personnel responsibilities
• Standard operating procedures
• Contamination
• Personal hygiene
• Cleaning
• Documentation
• Materials
• Process control
• Buildings and facilities
• Equipment
• Validation
• Calibration
• Laboratory
• Quality management system

For more information about this class:
Essentials for Medical Device Manufacturers by SkillsPlus International Inc

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Additional Keywords: biotech, cGMP, class, compliance, course, device,energizing, engaging, exciting, FDA, GMP, instructor, interactive, international, manufacturer, medical, QSR, seminar, SkillsPlus,trainer,training

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Live Onsite QSR Training - Olympics for Medical Device Manufacturers

Updated January 10, 2025

The "Olympics" course is no longer available.

You might also be interested in:

https://gmpprof.com/cgmp-training-a-new-generation/

---  the original post follows below  ---

Olympics for Medical Device Manufacturers - onsite QSR training by SkillsPlus International Inc. is an exciting, energizing, and engaging on-site class that can be held at a client in-house location.

This challenging class takes QSRs to a deeper level of understanding through a series of challenging activities.

Upon class completion, students will be able to:

1. List the hottest issues in QSR compliance. 
2. Locate items of interest in 21CFR820. 
3. Explain the 21CFR211 rationale for specific 483 observations. 
4. Demonstrate knowledge of common CGMP practices and details. 
5. State the consequences of not following QSR.

For more information:

Olympics for Medical Device Manufacturers - onsite QSR training by SkillsPlus International Inc.

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Additional Keywords: affordable, class, compliance, course, device, energizing, engaging, exciting, FDA, interactive, manufacturer, medical, QSR, SkillsPlus,

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Live Onsite QSR Training - Essentials for Medical Device Manufacturers

Here's one of our popular onsite QSR training classes:
Essentials for Medical Device Manufacturers by SkillsPlus International Inc.

This live class can be taught at the client site location of your choice.

This class teaches employees how to identify the essential elements of QSR for beginning work in the medical device industry.

Upon completion of this class, students will be able to:

1. State the historical development of QSR regulations. 
2. Explain the role and function of standard operating procedures. 
3. Describe the personal role for contamination control. 
4. Identify the sources of contamination. 
5. List the common QSR documentation practices. 
6. Explain material controls. 
7. State the common practices of production and process controls. 
8. Explain the importance of an adequate, appropriate, and sufficient building design. 
9. State the requirements of equipment design and construction. 
10. List the requirements for building, and equipment cleaning and maintenance. 
11. Explain the role of the quality management system. 
12. Explain the role of the laboratory.

Learn more about this class:
Essentials for Medical Device Manufacturers - On-site training by SkillsPlus International Inc.

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California HMDR Exemptee - Online Training

• California Exemptee Training - for home medical device retailers (HMDR). $525 per student. State approved by the CDPH. Earns a course completion certificate to accompany your Exemptee license application.

Updated February 27, 2026

SkillsPlus International Inc. is a long running provider of training to home medical device retailers (HMDR) and durable medical equipment (DME) wholesalers. Since 2002, SkillsPlus has provided up-to-date training for their clients. Our website page, California Exemptee HMDR and DME Providers Certification Course by SkillsPlus Intl Inc.,  provides information specific to the California Exemptee certification course.

California requires home medical device retailers 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 Department of Public Health as it meets training requirements for this training. To meet this requirement, 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.

• California Exemptee Training - for home medical device retailers (HMDR). $525 per student. State approved by the CDPH. Earns a course completion certificate to accompany your Exemptee license application.

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California Home Medical Device Retailer Exemptee License Application

• People also buy California Exemptee license training certification

Updated July 26, 2026

Application For California Home Medical Device Retailer Exemptee License

The application for the HMDR exemptee is provided for firms who wish to sell prescription Rx devices such as respiratory equipment, medical oxygen and other equipment identified as dangerous or legend devices under California law.  

You might also be interested in:
The California Exemptee HMDR and DME Providers Certification Course

Training program for California Home Medical Device Retailer (HMDR) Exemptee license applicants - Earn a completion certificate

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Energizing Online GMP-QSR Training

Image via WikipediaOnline training gets a bad rap, because there's so much bad stuff out there. Don't settle for simple page turners, or slides of boring content.  ... there's better training out there!

Our SkillsPlus International Inc. online training offerings are:

• engaging
• energizing
• exciting

SkillsPlus knows that you expect something social, movie interactive, and NOT BORING!  

Check out SkillsPlus International Inc. online training.

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Our New Home Page - SkillsPlus Intl Inc.

Never stand still.

We've been updating the SkillsPlus International Inc. home page.

The revamp is intended to make it easier for you to navigate to the products or services that you need.

Did we hit the mark?

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Select e-Learning That Is Pure, Safe and Effective

Buy Now! |  Current Good Manufacturing Practice Training: A New Generation Series - CGMP Online Courses

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!

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GMP and QSR Online Computer-Based Training (CBT) by SkillsPlus International Inc.

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An E-learning Black Box Warning: Caution, This Course May Be Hazardous to Your Sanity

• People think highly of FDA GMP Online Training - respected FDA CGMP online training courses provided by SkillsPlus International Inc.

I have taken many e-learning courses over many years.

Recently I purchased an e-learning course that really needed to carry a black box warning: Caution this course may be… After purchasing the class I signed in and after some struggling I finally found the first lesson. I clicked the link that said “start.” Well it did, sort of. A PowerPoint slide popped up. Now, I like PowerPoint if done well. However, this slide was full of text so small that I could not read it except by switching to my large screen monitor. There were two paragraphs of text. Now I must admit that I am getting a little older and perhaps the eye glasses need an update. So I waited for something to happen. I waited and waited, until I realized this was it. Read the text baby. So read I did, clicked continued, and finally got to the quiz. While taking the quiz, I wanted to review some content. No, that was not allowed. I responded to the questions the best that I could. If I missed the answer, the only feedback I got was, Incorrect!.

After one lesson I decided that there had to be a better way to learn. I found someone who offered the course in a true online e-learning environment.

Watch tomorrow’s blog to learn how to choose an e-learning provider.

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GMP and QSR Online Computer-Based Training (CBT) by SkillsPlus International Inc.

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Not All E-learning Is The Same

Everybody wants to offer online e-learning solutions for their staff training and development needs. But not all e-learning is the same. E-learning should go beyond reading a book on a computer screen. Honestly, if I am going to read the words on a page I would rather be under a fluffy blanket, and be curled up on the couch with a pot of hot tea and some butter cookies. E-learning should make full use of the technology of the computer.

• I want the instructor to talk to me, preferably, on the screen.
• Add some pictures, or better yet, add some live action video and animation.
• Provide some interaction to keep me fully engaged and challenged.
• Provide a handout to go along with the course so I can use that as a memory jogger after I have completed the course.

1. E-learning developers, challenge yourself to go beyond republishing the text book on the computer screen.
2. E-learning purchasers, demand more from your providers.

Watch for tomorrow’s post for an e-learning black box warning.

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SkillsPlus Intl Inc. - GMP Compliance Training Experts

GMP and QSR Online Computer-Based Training (CBT) by SkillsPlus Intl Inc.

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