Sunday, October 28, 2012

CA HMDR Exemptee Training - The Best Course Around

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.

To get a flavor of the web-based training, watch this snippet:

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

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Wednesday, October 17, 2012

What Is A Pharmacy Designated Representative?

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:

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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Tuesday, October 16, 2012

Medical device firms growing in South Florida

Medical device firms growing in South Florida - South Florida

"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."

'via Blog this'

You might also be interested in:
Essentials for Medical Device Manufacturers - Onsite Training This course teaches employees about the essential elements of the FDA's QSR regulations for starting work in the medical device industry

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SkillsPlus Intl Inc. website - GMP & QSR Compliance Training - Popular and Highly Regarded
SkillsPlus Intl Inc. - Sign-up for our announcements via Constant Contact

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Wednesday, October 10, 2012

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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SkillsPlus Intl Inc. - GMP & QSR Compliance Training Experts website
SkillsPlus Intl Inc. - Sign-up for our announcements via Constant Contact

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Monday, October 1, 2012

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

Updated August 16, 2018


GMP Trainer Awareness, Certification, and Master Trainer Certification Course

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