November is Natl Home Care and Hospice Month

• Buy now! California Exemptee Training Course.
• California HMDR Exemptee online training certification. Designated Representative Training | Exemptee Training. California Designated Representative online training courses. Florida CDR training and examination preparation. California HMDR Exemptee online training certification.
  

California Association for Health Services at Home:

"November is National Home Care & Hospice Month

Celebrate the Heroes of Home Care
Each November, the California Association for Health Services at Home (CAHSAH) along with the entire home care industry throughout the country celebrates National Home Care and Hospice Month to honor care giving heroes who make a remarkable difference in the lives of patients and the families they serve. It is an important opportunity to recognize the health care administrators, nurses, clinicians, therapists, aides, homemakers, chore workers, companions and other home care professionals who assist some of our most frail citizens and help them to remain at home and in the community.

“During National Home Care and Hospice month, we take time to honor the thousands of individuals in home care and hospice who, on a daily basis, provide remarkable care in people’s homes. Thank you for all that you do.” - - - CAHSAH President Joe Hafkenschiel"

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You might also be interested in:
CA HMDR Exemptee online training certification - for HME DME retailers
The Designated Representative and Exemptee Blog

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CA Designated Representative internet-based training certification by SkillsPlus Intl Inc.
FL Designated Representative web-based exam preparation.

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

CA HMDR Exemptee Training - The Best Course Around

• Buy Now! - California HMDR Exemptee license training certification course

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.

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

SkillsPlus International Inc. is a long running provider of training to home medical device retailers (HMDR) and durable medical equipment (DME) providers.

Since 2002 SkillsPlus has provided up-to-date training for their clients. This website page, California Exemptee Training Certification Course,  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, and meets the training requirements of, the CA Department of Public Health, and covers:

• California Code of Regulations 
• Business and Professions Code 
• Prescription Drug Laws 
• Controlled Substances 
• USP Storage Conditions 
• Health and Safety Code 

Prospective Exemptees can meet the training requirement by taking SkillsPlus Intl Inc.'s web-based, self-study class (that includes a final exam) for training certification. The class is fast, to the point, and has helped thousands of potential California Exemptees get licensed.

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• What Is A Pharmacy Designated Representative? (skillsplusinfo.blogspot.com)

What Is A Pharmacy Designated Representative?

• California Designated Representative online training courses. Designated Representative Training | Exemptee Training. California Designated Representative online training courses. Florida CDR training and examination preparation. California HMDR Exemptee online training certification.
• Buy a California Designated Representative course now, for:
        Wholesalers | 3PL | Reverse Distributors

Updated June 27, 2018

California Designated Representative Licenses

Now there are more California Designated Representative license types (including, but not limited to):

• California Designated Representative - Wholesaler
• California Designated Representative - 3PL (third-party logistics provider)
• California Designated Representative - Reverse Distributor

If you're applying for any one of these licenses, you might be interested in the following training courses. Successful completion earns a training affidavit (accepted by the California Board of Pharmacy):

Training programs for California Designated Representative license applicants  -  Earn a training affidavit

- -  the original post follows below  - -

If you're new to the pharmacy world of the Designated Representative, maybe this quick introduction will help. I'm going to explain, using the California (CA) State Board of Pharmacy as the example.

According to the CA Designated Representative application form:

A designated representative is an individual who performs clerical, inventory control, housekeeping, delivery, maintenance, or similar functions related to the distribution or dispensing of dangerous drugs or dangerous devices. To work as a designated representative, you must possess and keep a current certificate as a designated representative.

There are quite a number of requirements that have to be met in order to qualify, including the following training requirements listed on the application form:

Complete a training program that, at a minimum, addresses each of the following subjects:
(A) Knowledge and understanding of California and federal law relating to the distribution of dangerous drugs and dangerous devices.
(B) Knowledge and understanding of California and federal law relating to the distribution of controlled substances.
(C) Knowledge and understanding of quality control systems.
(D) Knowledge and understanding of the United States Pharmacopoeia standards relating to the safe storage and handling of drugs.
(E) Knowledge and understanding of prescription terminology, abbreviations, dosages and format.

The trick then becomes finding a way to fulfill the training program requirement.

SkillsPlus International Inc. offers designated representative training for California and Florida, so you might be interested in:

CA Designated Representative online training certification - for drug wholesalers

FL Designated Representative online exam preparation - for drug wholesalers

The Designated Representative and Exemptee Blog

CA Home Medical Device Retailer (HMDR) Exemptee online CBT training certification by SkillsPlus Intl Inc.

SkillsPlus Intl Info Blog

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Medical device firms growing in South Florida

Medical device firms growing in South Florida - South Florida Sun-Sentinel.com:

"Florida is the fastest-growing state in creating new biotech companies and ranks second in medical device firms, according to global research firm Battelle. The southeastern region of the state, which includes Broward and Palm Beach counties, has the largest number of bioscience companies in Florida, as tracked by a University of Florida life science database.

Venture capitalists and investors are taking notice, listening to pitches at last week's BioFlorida conference from local firms seeking partners and funding. But there are many hurdles to success.

For medical devices, those challenges include ongoing financing of research, completing successful clinical trials, paying for expensive regulatory approvals, and ultimately getting hospitals and doctors to use the products."

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PDA Biennial Training Conf - Oct 2012 - A success!

Just got back from a great PDA meeting in Bethesda: the PDA Biennial Training Conference - From training to learning - Improving performance in a regulated environment.

I took advantage of the opportunity to go on a tour of the PDA offices and TRI (training and research institute).  Very impressive learning labs and classroom facility.

It was great to re-connect with our industry friends. Needless to say, there was very palpable interest in e-Learning,

For those interested in finding our cGMP and QSR e-Learning courseware, I've included the following links to collections of what SkillsPlus Intl Inc. has to offer:

e-Learning Courses offered by SkillsPlus International Inc.
e-Learning Courses offered by SkillsPlus International Inc. - Course Descriptions (PDF)

For more information about the PDA (Parenteral Drug Association)

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FDA - ANDA Stability Testing - New Draft Guidance Document

• FDA cGMP online training classes, courses, and programs offered by SkillsPlus International Inc.

Updated October 31, 2022:

The FDA just released a new draft guidance document pertaining to stability testing of generic drug products and substances which calls for sponsors to rely on five existing standards promoted by the International Conference on Harmonisation (ICH).

Guidance for Industry: ANDAs: Stability Testing of Drug Substances and Products

The following existing ICH guidances address stability for new drug substances and products, and are referred to in the FDA guidance:

1.     Q1A (R2) Stability Testing of New Drug Substances and Products.
2.     Q1B Photostability Testing of New Drug Substances and Products.
3.     Q1C Stability Testing for New Dosage Forms.
4.     Q1D Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products.
5.     Q1E Evaluation of Stability Data 

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QSR and cGMP Trainer Certification - 2012 Public Seminar - Registration Ends Soon

Updated March 14, 2021

Announcing:

GMP Trainer Awareness, Certification, and Master Trainer Certification Course

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

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. 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, Certification, and Master Trainer Course - a train-the-trainer course for FDA QSR cGMP trainers

 - -   original post follows below  - -

Next week is the registration deadline for the cGMP & QSR Trainer Certification Public Seminar in San Francisco (October 22-26, 2012).

For more information:
cGMP/QSR Trainer Certification Program - A public seminar by SkillsPlus International Inc.:

This is a five-day class in which participants experience many different ways to teach CGMPs and QSRs. Students get to see and learn what the instructor is thinking about during sessions, so that the training approaches can be applied back at the student's company. Students make two presentations demonstrating their skills during the class. This class is also suitable for food and dietary supplement manufacturers.

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cGMP & QSR Trainer Certification - 2012 Public Seminar - Seats Nearly Gone

Updated March 14, 2021

You might also be interested in our online version of the course:

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

--- original post follows below  ---

Don't delay!

Our annual public seminar is nearly sold out.

Register now for this very popular in-person course:

CGMP/QSR Trainer Certification Program - Public Seminar by SkillsPlus International Inc.

This public seminar will be held October 22-26, 2012 in beautiful San Francisco.


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

Highly Recommended QSR & GMP Trainer Certification

Updated June 12, 2025

GMP Trainer Awareness, Certification, and Master Trainer Courses (online 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. 

Questions? Call us: (415) 948-5220

- - -  original post follows below  - - -

GMP & QSR Trainer Certification Program
(offered as a public seminar Oct 22-26, 2012 in San Francisco, CA)

Refine your skills and become the best QSR or GMP trainer that you can be!

Learn about things to do in San Francisco:  San Francisco Travel for Visitors

This is a five-day class where participants experience many different ways to teach CGMPs and QSRs. Then 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.

For more details, check-out the brochure: CGMP/QSR Trainer Certification Program (PDF)

To register for the class: Register for the CGMP/QSR Trainer Certification Program

Public Seminar Schedule and Course Description:  SkillPlus International Inc.

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FDA 483s Can Form Basis of Class Action Lawsuit

• Trusted FDA cGMP online training programs and courses offered by SkillsPlus Intl Inc.

In the long list of things that are inadvisable to regulatory professionals, making misleading statements to the authority in charge of regulating your business likely ranks near the top. Those found to have misled the U.S. Food and Drug Administration (FDA) have in the past been publicly warned, fined, imprisoned, shut down and barred from participating in federal programs.

Now KV Pharmaceuticals is facing the prospect of an additional action: a class-action shareholder lawsuit as the result of an FDA inspection report. This is an important event, and here's why . . .

Judge: Regulatory Inspection Report Can Form Basis of Class Action Lawsuit - RAPS - News - Article View:

"On Monday, 4 June a federal appeals court ruled a securities fraud class action lawsuit could proceed against pharmaceutical manufacturer KV Pharmaceuticals for purportedly causing $1.5 billion in shareholder losses after first misleading FDA about manufacturing problems at a facility and later shutting down the facility’s manufacturing operations."

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What's important to note is that this decision is a marked reversal from existing precedence, which has found Form 483 reports to be immaterial to federal securities law.

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