Saturday, December 31, 2011

Don't Get Caught Without A California HMDR Exemptee

Avoid jeopardizing your business.
  • Don't get caught without a California Department of Public Health (CDPH) Home Medical Device Retailer (HMDR) Exemptee.
  • It's a wise investment to have more than just one Exemptee, so that you have additional Exemptees for backup and cross-covering.
  • The cost of training another Exemptee is very reasonable, in contrast to having to close down the business.
Here's a free tip:
One of many minimum qualifications to become a California HMDR Exemptee is work experience. Applicants must have one or more years paid experience. Training must have been supervised by a licensed exemptee, Pharmacist-In-Charge or equivalent. No exceptions!

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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
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Thursday, December 22, 2011

2012 cGMP QSR Trainer Certification Course - Public Seminar

Updated May 6, 2014:


Did you miss our public seminar? We also offer this program as an on-site course conducted at your location. Give us a call: (415) 487-3500, or learn more:  http://www.skillsplusinc.com/Pub_Sem.htm

---
Announcing our 2012 offering in scenic San Francisco:
cGMP/QSR Trainer Certification Program - a 2012 Public Seminar by SkillsPlus International Inc.

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.

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

SkillsPlus Intl Inc. - GMP Compliance Training Experts website
SkillsPlus Intl Inc. - Sign-up for our announcements via Constant Contact
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
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Wednesday, December 14, 2011

Florida Designated Representative - Online Exam Preparation Course

Florida Designated Representative Exam Preparation Course: SkillsPlus International Inc.:
"Florida requires Designated Representatives working at drug and device wholesalers to be trained in specific Florida Pharmacy Laws. SkillsPlus offers an on line self study course that helps prospective Designated Representatives to prepare for the examination. Simply enroll and follow the links in a confirmation email and you are on your way."
'via Blog this'

Here's a free preview of the course:


You might also be interested in:
Selecting e-Learning that is Pure, Safe, and Effective


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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
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Wednesday, December 7, 2011

California HMDR Exemptee - Online CBT Training

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. For those seeking two certifications, this course also meets the requirements for the California Designated Representative. 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.


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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
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Tuesday, December 6, 2011

e-Pedigree - CA Board of Pharmacy Mtg 9/7/2011

Skillsplusinc's Channel - YouTube:

The CA Board of Pharmacy finally posted the minutes to this meeting.

It includes:
Discussion on the Implementation of California’s Electronic Pedigree Requirements for Prescription Drug (PDF)

'via Blog this'

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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

Monday, December 5, 2011

Human Errors - cGMP Training

Learn how to overcome human errors as a root cause to deviations, when human errors are the wrong diagnosis:
Human Errors: Overcoming the Challenges - a SkillsPlus International Inc. training class
Upon class completion, students will be able to:

  1. State what the cGMPs imply regarding human errors. 
  2. State the FDA's current thinking about human errors and deviations. 
  3. Describe the basics of root cause determination. 
  4. List the possible root causes to human errors.
The course covers the following topics:

Introduction
1. Activity: Heard on the street
2. What the FDA says about human errors and deviations
3. How many human errors are too many
4. Recent 483 observations relating to human error

Understanding human error
1. The psychology of human error
2. Sources of human error

Investigating human error
1. Activity: A simple human error
2. 5-Why's
3. Sequence of events
4. Distinctions
5. Walk through analysis
6. Fish bone diagramming and root cause analysis
7. Types of root causes

Preventing human errors
1. CAPA (Corrective Action and Preventive Action)
2. Control barrier analysis
3. CGMP Challenge: Human Errors

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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

Wednesday, November 23, 2011

Deviation Investigation Reports - Training Class

Food and Drug Administration logo
Image via Wikipedia
Many FDA observations are caused by failures in deviation management and CAPA.

We can help you in this area, through this course:
Deviation Investigation Reports - a SkillsPlus Intl Inc. training class

This class teaches students how to use the data collected in an investigation to write a report and answer management and FDA questions.

After completing the class, students will be able to:
  1. Increase investigation report suitability for FDA review. 
  2. Decrease the number 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.
This class is energizing and exciting, and uses the following teaching approaches:
  • In-house deviation reports will be used to demonstrate and practice the skills and principles of this class. 
  • This course is best taught in a computer lab. We can ship computer labs to your site if needed. 
  • 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.
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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

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Tuesday, November 22, 2011

Time To Start Planning Your 2012 cGMP and QSR Training

The new year is almost upon us.

Don't delay. Get a jump on planning your 2012 training offering.

Check out our training options and offerings on the SkillsPlus International Inc. web site - we're the The Leader in Compliance Training: cGMP, QSR and State Licenses.

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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
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Monday, November 21, 2011

It's Not Too Late To Spend Your 2011 Training Funds

2011 is coming to an end.

Do you still have 2011 training funds that you need to spend (or lose!)?

Then check out our training options and offerings on the SkillsPlus International Inc. web site - we're the The Leader in Compliance Training: cGMP, QSR and State Licenses.  

You might be especially interested in our catalog of engaging & energizing online computer-based training (CBT) courses.

  • avoid the hassle of coordinating a last minute on-site class
  • avoid the bother of trying to deal with your trainer's travel expenses, and more
  • have students take the online classes by computer, without totally disrupting the production line

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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



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Wednesday, November 16, 2011

Root Cause Analysis - cGMP Training Class

Learn how 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.

Root Cause Analysis for Better Investigations is a live training class. Upon course completion, students will be able to:

  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.

In-house projects will be used to demonstrate and practice the skills and principles of this class.

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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
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Tuesday, November 15, 2011

Batch Record Review Training - a live cGMP class

Learn how to review batch records to identify errors and issues.

Faster Product Release Through Efficient Batch Record Review is a live training class. Upon course completion, students will be able to:
  1. State the source of batch record requirements for both US and EU 
  2. Distinguish between the production and QA batch record review 
  3. List best practices in Batch Record Review 
  4. Demonstrate at least 5 different batch record review activities
In-house projects will be used to demonstrate and practice the skills and principles of this class.

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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
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Monday, November 14, 2011

Pearson VUE: Florida Certified Designated Representative

Pearson VUE: Florida Certified Designated Representative - Drugs, Devices and Cosmetics:  'via Blog this'

The Pearson VUE website contains specific information about Florida Certified Designated Representative - Drugs, Devices and Cosmetics testing. Register for your next exam, find test information, or download handbooks/applications/forms from this page.

You might be interested in:
Florida Certified Designated Representative Study Course - an online training

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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
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Wednesday, November 9, 2011

CA HMDR Facilities Must Have Policies and Procedures

The CA Home Medical Device Retailer (HMDR) licensing program is governed by law sections found in the California Sherman Food, Drug and Cosmetic Law. The Sherman Law was amended in the 1999-2000 legislative session to establish the HMDR licensing program. The applicable sections can be found in an abstract of the Sherman Law on this CDPH HMDR Sherman Law and FAQ Links webpage.

Section 111656.3 starts out with:
"Each home medical device retail facility shall have written policies and procedures related to home medical device handling and, if authorized by the department pursuant to Section 111656.4, the dispensing of prescription devices. Those written policies and procedures shall be adequate to assure compliance with this article and shall include, but not be limited to . . . "
Notice the phrase, " . . . shall have written policies and procedures . . . "

Not quite sure how to begin, and start writing them?

Then you might be interested in:
Buy Now: Writing Procedures: Drug and Device Wholesalers and HMDR 
 - an online training course from SkillsPlus International Inc.
Learn to write procedures quickly and thoroughly. Allan shares his experiences and techniques for writing procedures. This class is based on 30 years of experience writing procedures and teaching others to write them. This class is only for drug and device wholesalers, DME's and home medical device retailers. Pharmacists and pharmacy technicians responsible for procedures in their firm may also benefit. 

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SkillsPlus Intl Inc. - The Best GMP Training & cGMP Training Around
Root Cause Analysis - GMP Training
Deviation Investigation Report Writing - GMP Training
Qualstar Simulation - Advanced GMP Training That's Fun!

 


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
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Tuesday, November 8, 2011

Find Nearest Test Center for FL Certified Designated Representative Exam

Find The Nearest Test Center for The FL Certified Designated Representative Exam - Pearson VUE:    'via Blog this'
A link to help you locate a test center near you for the Florida CDR (Certified Designated Representative) Exam.
You might also be interested in:
Florida Designated Representative Study Course by SkillsPlus

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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
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Monday, November 7, 2011

CA Home Medical Device Retailer Exemptee License Application

Application For CA Home Medical Device Retailer Exemptee License | Designated Representative and Exemptee:     'via Blog this'
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

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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
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Wednesday, November 2, 2011

FDA GMP QSR Public Seminar - East or West Coast Location?

Updated May 6, 2014:


Did you miss our public seminar? We also offer this program as an on-site course conducted at your location. Give us a call: (415) 487-3500, or learn more:  http://www.skillsplusinc.com/Pub_Sem.htm

---
We need your input for planning purposes.

SkillsPlus International Inc. has been proud to offer the CGMP/QSR Trainer Certification Program (a public seminar by SkillsPlus Intl Inc.) for quite a long time without having to cancel a publicized class.

Our students just love this program! Just read some testimonials about SkillsPlus International Inc. training offerings.

We want to make sure there's enough demand for our public seminar in the right places, specifically, East versus West coast.

Here's what we'd like.  We need to hear from you!

Is there enough demand to offer our train the trainer certification course on the East, West, or both coasts?

Please sound off by commenting to this post.

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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
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Thursday, October 13, 2011

FL Certified Designated Representative - Oct 2011 Candidate Info Booklet

Topographic map of the State of Florida, USA (...Image via Wikipedia
- - - - -
6/29/2012 update.

CAUTION - there are old versions of the candidate information booklet (CIB) that can be found on the internet. Be sure you're referencing the most current version. The most current version, as of today, is the June 2012 edition. Here's how I found it.

Go to the home page of the Florida Department of Business and Professional Regulation:  http://www.myflorida.com/dbpr

In the search box, enter "CDR CIB"   In the search results, click on "Candidate Information" and there you have it!

For your quick reference, here's the June 2012 CDR CIB:  http://www.myfloridalicense.com/dbpr/servop/testing/documents/CDR.CIB.pdf
- - - - -

Here's the latest version of the CIB:
State of Florida - Candidate Information Booklet (CIB) for the Certified Designated Representative Laws and Rules Examination - Oct 2011.

Beware, there are older versions out there.

If you're preparing to take the Florida CDR Exam (Certified Designated Representative), make sure you're referencing the latest and most current version of the CIB (candidate information booklet).

While simply Googling, I ran across three different versions of the CIB.  One was the outdated October 2010 version, another was dated March 2011.

Bottomline, be sure you find and reference the most current version of the CIB.

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Additional Keywords: affordable, based, biotech, CA, CBT, CDR, certification, certified, Certified Designated Representative, cGMP, class, compliance, computer, computer-based training, course, 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, pharmaceutical, prep, preparation, provider, public, QSR, representative, resources, seminar, SkillsPlus, social, trainer, training, video, WBT
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Wednesday, October 12, 2011

Energizing Online GMP-QSR Training

Online education and Financial AidImage 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!  


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Additional Keywords: affordable, based, biotech, CA, CBT, CDR, certification, certified, Certified Designated Representative, cGMP, class, compliance, computer, computer-based training, course, 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, pharmaceutical, prep, preparation, provider, public, QSR, representative, resources, seminar, SkillsPlus, social, trainer, training, video, WBT
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Monday, October 10, 2011

Our New Home Page - SkillsPlus Intl Inc.

Never stand still.


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

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Wednesday, October 5, 2011

Select e-Learning That Is Pure, Safe and Effective

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.

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

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Tuesday, October 4, 2011

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

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

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

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Monday, October 3, 2011

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.

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

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Monday, September 26, 2011

PDA FDA - Interesting Manufacturer Statistics

At the recent international PDA/FDA meeting, some very interesting statistics were shared. Drug products are manufactured in over 130 countries. In those 130 countries, there are over 300,000 manufacturers. Those manufacturers work through 130,000 importers. It is no surprise that the FDA requires drug manufacturers to audit suppliers and assure that the plant shown is the plant that will manufacturer the drug product. The FDA wants to make sure that there are no "shadow plants" being operated out of CGMP compliance.

To learn more about current GMP rules, visit our website:
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Additional Keywords: affordable, based, biotech, CA, CBT, CDR, certification, certified, Certified Designated Representative, cGMP, class, compliance, computer, computer-based training, course, designated, designated representative, device, DME, drug, elearning, e-learning, etraining, e-training, exam, examination, exemptee, FDA, FL, Florida, glossary, GMP, HMDR, HME, IBT, instructor, interactive, International, internet, manufacturer, medical, online, pharmaceutical, prep, preparation, provider, public, QSR, representative, resources, seminar, SkillsPlus, trainer, training, video, WBT

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Thursday, September 22, 2011

Ready For Drug Pedigree Rules?

I recently attended a conference that included representatives from the European, Asian, and U.S. regulatory agencies. At that meeting there was much discussion around pedigree rules.

Some of the concerns expressed begin with importing drugs and bulk actives (now called active pharmaceutical ingredients (APIs)). At this level, manufacturers are required to qualify supplies. This means that a manufacturer must actually visit the API manufacturing site to assure themselves, and the public, that the production facility shown to the auditor is the actual site of manufacture, and that there is no "shadow site" where the real work takes place.

Internationally, there are different approaches to the pedigree. In Europe there is exploration with a "book ends" approach. This approach requires the manufacturer to issue the initial pedigree. The next pedigree touchpoint is at the pharmacy when the product is dispensed to the patient. The thinking is that if the product is moving between known distribution channels, then the product is protected. The U.S. requirement is to document every change in ownership. This means that every touchpoint is documented. Yes, regulators in Europe realize that this approach probably provides better assurance of the supply chain. However, they are also concerned about how much work to pass on to the smaller distributors who may not be staffed for this level of documentation.

Learn more about e-Pedigree in our online computer-based training (CBT) courses:

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Monday, September 19, 2011

Online GMP Training - 21 CFR 820: Essential Elements

An example of the stent used in an EVAR procedureImage via WikipediaTake this online CBT (computer based training) if you need to review the 21 CFR 820 regulations from the perspective of being inside a medical device manufacturing facility. Learn the rules affecting medical device manufacturing, while getting a glimpse of medical device production techniques.
This class is appropriate for all employees of medical device manufacturing organizations. Upon the completion of the class, employees will be able to summarize the 15 subparts.

Online computer-based training (CBT) is the way to complete required training at minimal cost.

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

Monday, September 12, 2011

FL Certified Designated Representative - Use The Most Current CIB

An enlargeable map of the 67 counties of the S...Image via WikipediaFL CDR - Caution - Use the most current CIB | Designated Representative and Exemptee: 'via Blog this'

- - - - -
6/29/2012 update.

CAUTION - there are old versions of the candidate information booklet (CIB) that can be found on the internet. Be sure you're referencing the most current version. The most current version, as of today, is the June 2012 edition. Here's how I found it.

Go to the home page of the Florida Department of Business and Professional Regulation:  http://www.myflorida.com/dbpr

In the search box, enter "CDR CIB"   In the search results, click on "Candidate Information" and there you have it!

For your quick reference, here's the June 2012 CDR CIB:  http://www.myfloridalicense.com/dbpr/servop/testing/documents/CDR.CIB.pdf
- - - - -

We continue to see two versions of the Florida Certified Designated Representative (CDR) Candidate Information Booklet (CIB) out on the internet.

Make sure you are looking at the most current version of the CIB. There's an older October 2010 version floating around. At the time of this post, there's a more current version, March 2011 that's been published.

Reference:
CANDIDATE INFORMATION BOOKLET for the Florida CERTIFIED DESIGNATED REPRESENTATIVE LAWS AND RULES EXAMINATION COMPUTER BASED TEST (CBT) MARCH 2011

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Monday, September 5, 2011

e-Pedigree - CA Board of Pharmacy

We'll be attending the Sept 7th CA Board of Pharmacy meeting, where one of the agenda items is e-Pedigree ...




Updated 12/6/2011:
The minutes finally got posted. You can find them here, and they include:
Discussion on the Implementation of California’s Electronic Pedigree Requirements for Prescription Drug

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Monday, August 29, 2011

CA Pharmacy Designated Representative - Online CBT Training

We offer a very popular online training course, California Designated Representative Training by SkillsPlus International Inc. This program is CBT (computer based training).


You should consider this online training course, because it's so convenient!
  1. It's available to you 24/7, anytime you want.
  2. It's online computer-based training (CBT) that you can take in the comfort of your home or office
  3. There's no need for you to travel!
This class meets the requirements for the State of California Designated Representative.
This is an on-line self-study pre-recorded presentation with animation and text.
Each presentation is followed by the final exam for that section of the class.


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