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

Return to SkillsPlus International Info Blog - Home

SkillsPlus Intl Inc. - The Best GMP & QSR Compliance Training Around

Designated Representative Training | Education

• California Designated Representative Training (approved by the California State Board of Pharmacy)
• Florida Certified Designated Representative - CDR Exam Prep Course

Training Program For California Designated Representative License Applicants

SkillsPlus International Inc.'s California Designated Representative training courses are accepted by the California State Board of Pharmacy.

California requires drug and device wholesalers to retain a CA-licensed pharmacist or Designated Representative, on-site, to conduct their business. The pharmacist or Designated Representative must be physically present during all hours of operation.

Florida requires Designated Representatives working at drug and device wholesalers to be trained in specific Florida pharmacy laws.

---

Follow this link, to learn more about pharmacy Designated Representative training, on the Designated Representative Institute website

Note:
In CA, the pharmacy Designated Representative was formerly called the Exemptee.

Return to SkillsPlus International Info Blog - Home

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

• CA HMDR Exemptee online internet-based training certification by SkillsPlus Intl Inc.
• The Exemptee Institute

• CA Designated Representative-3PL online training certification by SkillsPlus Intl Inc.- We'll send you the 3PL training affidavit upon successful course completion.
• CA Designated Representative online web-based training certification by SkillsPlus Intl Inc. - Available around-the-clock 24 x 7
• FL Certified Designated Representative (CDR) online exam prep course - Lots of practice exams - Practice makes perfect!
• The Designated Representative Institute

• The Designated Rep and Exemptee Professionals Blog
• SkillsPlus Intl Info Blog

Stop Blaming The Same Old "False" Root Causes

Updated May 19, 2022

Now offered as an online training program!

View advanced cGMP training courses taught by SkillsPlus International Inc.

---  the original post follows below  ---

Pinpointing the wrong cause (for example, a "false" root cause) can result in ineffective immediate, corrective, and preventive actions.

• Throwing fixes at the wrong things might not fix the problem.
• Blaming and overusing human error as the root cause can result in incomplete and ineffective root cause analysis.

By taking our courses, you'll more confidently identify the real root causes, and craft clearer and more concise investigation reports.

.

These highly popular cGMP & QSR training classes are taught at the location of your choice, as a client on-site in-house training. You might be interested in two of our highly inter-related courses.

1. Root Cause Analysis for Better Investigations, and
2. Deviation Investigation Reports

- - - FIRST - - -

Root Cause Analysis for Better Deviation Investigations: On-site Training by SkillsPlus International Inc.:

"Purpose:

• To conduct or facilitate an individual or team-based investigation that solves problems and gets results, and complies with FDA expectations in the pharmaceutical and biotech industries. 

Objectives
1. Use tools and techniques to effectively identify the deviation statement.
2. Identify the root cause of the deviation.
3. Generate and objectively select the best corrective and preventive actions.
4. Assess the risk of implementing the corrective action and preventive action.
5. Develop a contingency plan to preventive action implementation.
6. Create corrective actions and preventive action metrics. 

About the Class
1. This class uses current deviations to practice the techniques taught.
2. The optional final exam is approximately 25 questions.
3. Each student receives a student guide containing a representation of the program's
slides and graphics with space provided for note taking.
4. This class can accommodate up to 25 people.
5. Duration: 8 hours."

'via Blog this'

- - - SECOND - - -

Deviation Investigation Reports: On-Site Training by SkillsPlus International Inc.:

Purpose:

• To use the data collected in an investigation to write a report and answer management and FDA questions.

 Objectives 

1. Increase investigation report suitability for FDA review. 
2. Decrease the number of reports returned by internal reviewers. 
3. Write supported deviation statements. 
4. Provide a detailed background statement to include related information, investigations, affected materials and references. 
5. Document deviation investigation findings. 
6. State the root cause with supporting facts. 
7. Generate supported, plausible, and defensible corrective actions. 
8. Develop effectiveness measures for the corrective actions. 
9. Generate realistic preventive actions. 
10. Develop effectiveness measures for the preventive actions. 
11. Develop a follow up plan for corrective and preventive actions. 
12. Write accurate executive summary statements. 

 About the Class

1. In-house deviation reports will be used to demonstrate and practice the skills and principles of this class.
2. This course is best taught in a computer lab. We can ship computer labs to your site if needed.
3. This course is customized to reflect your company procedure on writing deviation investigation reports. As we review that document we will make any recommendations to for change that we feel would be helpful.
4. The optional final exam is approximately 25 questions.
5. Each student receives a student guide containing a representation of the program's  slides and graphics with space provided for note taking.
6. This class can accommodate up to 12 people.
7. Duration: 8 hours as a minimum.

For more information:

• Root Cause Analysis for Better Deviation Investigations: On-site Training by SkillsPlus International Inc.
• Deviation Investigation Reports: On-Site Training by SkillsPlus International Inc.

Return to SkillsPlus International Info Blog - Home

SkillsPlus Intl Inc. - GMP & QSR Compliance Training Experts website

FDA Considers New Quality Metrics

FDA Seeking Industry Input on Quality Metrics to Help Rationalize Its Review and Inspection System | IPQ Newsletter:

"Based on its review of all the responses submitted on the metrics issue, FDA has chosen three that it is considering using and is seeking additional feedback on:

• batch failure rate
• right first time, and
• out-of-specification (OOS)/laboratory failure investigation rates"

Return to SkillsPlus International Info Blog - Home

SkillsPlus Intl Inc. - The Best GMP & QSR Compliance Training Around

FDA Gets EC Waiver To Export APIs

Press Announcements > FDA obtains waiver from European Commission to facilitate export for U.S. pharmaceutical manufacturers:

" . . . the U.S. is now a “listed” country with the European Commission (EC) so that U.S. companies need not obtain an export certificate from the FDA before shipping certain pharmaceutical products to Europe.

Without the waiver, all U.S. companies shipping active pharmaceutical ingredients (APIs) to Europe after July 1, 2013 would have had to first submit documentation from the FDA that the product was manufactured in accordance with Europe’s good manufacturing practices."

Return to SkillsPlus International Info Blog - Home

SkillsPlus Intl Inc. - The Best GMP & QSR Compliance Training Around

MRI Screening - After Contaminated Injections - JAMA

JAMA Network | JAMA | Magnetic Resonance Imaging Screening to Identify Spinal and Paraspinal Infections Associated With Injections of Contaminated Methylprednisolone AcetateFinding Infections After Contaminated Injections:

"Conclusions and Relevance :  Among patients who underwent screening MRI to look for infection at the site of injection of contaminated methylprednisolone, 21% had an abnormal MRI, and all but one met CDC criteria for probable or confirmed fungal spinal or paraspinal infection. Screening MRI led to identification of patients who had minimal or no symptoms of spinal or paraspinal infection and allowed early initiation of medical and surgical treatment."

Return to SkillsPlus International Info Blog - Home

CA Designated Representative online web-based training certification by SkillsPlus Intl Inc.
FL Designated Representative online e-Learning exam preparation by SkillsPlus Intl Inc.
The Designated Representative Institute

SkillsPlus Intl Inc. - The Best GMP & QSR Compliance Training Around

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: . . . "

Return to SkillsPlus International Info Blog - Home

SkillsPlus Intl Inc. - The Best GMP & QSR Compliance Training Around

FDA : Draft Guidance - Contract Manufacturing Arrangements for Drugs: Quality Agreements; Availability

• People also need FDA GMP Online Training - recommended FDA CGMP online training classes offered by SkillsPlus International Inc.

Comments are due to FDA by July 29, 2013.

Federal Register | Draft Guidance for Industry on Contract Manufacturing Arrangements for Drugs: Quality Agreements; Availability:

"This guidance describes our current thinking on defining, establishing, and documenting the responsibilities of each party (or all parties) involved in the contract manufacturing of drugs subject to Current Good Manufacturing Practice (CGMP). In particular, we describe how parties involved in the contract manufacturing of drugs can utilize Quality Agreements to delineate their responsibilities and assure drug quality, safety, and efficacy."

Return to SkillsPlus International Info Blog - Home

SkillsPlus Intl Inc. - The Best GMP & QSR Compliance Training Around

Food or Dietary Supplement - Therapeutic Claims = Drugs

FDA Law Blog: Using Scientific Literature in Food or Dietary Supplement Marketing? Proceed with Caution:

"Recent actions by FDA and the FTC serve as reminders that both agencies will consider the use of scientific literature in determining whether marketing for a food or dietary supplement conveys disease treatment or prevention.

FDA recently issued a warning letter to a company that sells eye health dietary supplements. FDA alleged that the company’s website included “therapeutic claims” that established that its products were unapproved new drugs."

Return to SkillsPlus International Info Blog - Home

SkillsPlus Intl Inc. - The Best GMP & QSR Compliance Training Around

Choose Live On-Site Instructor-Led GMP Training - - Benefits

Updated March 10, 2021

Given the COVID-19 pandemic, people also search for CGMP online training such as:

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

- - -  the original post follows below  - - -

On-site training, taught live by an instructor, is the perfect choice for companies that need to train groups of employees.

The Benefits of Live On-Site Instructor-Led cGMP Training:

You'll . . .

1. Get a maximum number of employees trained in new skills in a minimal amount of time on the date, and location of your choice. 
2. Be able to deliver the same customized message & course content at the same time, ensuring everybody gets on the same page. 
3. Ensure knowledge & skills transfer from classroom to workplace.
4. Get an expert trainer's insights and hear real-world examples.
5. Experience face-to-face interaction with real-time feedback.
6. Get a more comfortable training environment that supports the learning of complex material.

Taking advantage of onsite instructor-led training classes gives you the optimal balance of facilitation, group exercises, case studies, and practical application exercises. Learn more, call: (415) 948-5220.


Return to SkillsPlus International Info Blog - Home

SkillsPlus Intl Inc. - GMP and QSR Compliance Training Experts website

 

Additional Keywords: affordable, based, biotech, CA, CBT, CDPH, CDR, certification, certified, Certified Designated Representative, cGMP, class, compliance, computer, computer-based training, cosmetics, course, DBPR, DDC, designated, designated representative, device, DME, drug, eCourse, e-Course, elearning, e-learning, energizing, engaging, etraining, e-training, exam, examination, exemptee, exciting, FDA, FL, Florida, glossary, GMP, HMDR, HME, IBT, instructor, interactive, International, internet, manufacturer, medical, movie, online, Pearson VUE,pharmaceutical, prep, preparation, provider, public, QSR, representative, resources, seminar, SkillsPlus, social, trainer, training, video, WBT