Wednesday, November 23, 2011

Deviation Investigation Reports - Training Class

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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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