Showing posts with label sop. Show all posts
Showing posts with label sop. Show all posts

Wednesday, December 9, 2015

Need Annual Refresher Training? - Designated Representatives & Exemptees

Have a Designated Representative or HMDR Exemptee that needs refresher training?

You might have said yes, if:
  • it's been several years since they've reviewed applicable regulations 
  • ongoing training hasn't kept pace with company standard operating procedures (SOPs)
  • an inspector or auditor recommends that annual or refresher training needs to be taken, or
  • a recent violation results in mandated remedial training

Return Home:  The Designated Representative and Exemptee Blog

For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):
     Florida:

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):


Thursday, January 24, 2013

Dirk Rodgers on Inference

Another excellent article by Dirk Rodgers and touchpoints with California law.  The following snippet just happened to catch my eye.

How Should Inference Work?:

" . . . Companies will need to create and document their Standard Operating Procedures (SOPs) for making use of the container serial number hierarchy when they infer the contents in each business process.  According to the law, this will need to include some kind of statistical sampling process for determining the accuracy of the aggregation information provided to them.  The SOPs will need to be available for the Board to review them. . . ."

'via Blog this'

You might also be interested in:
Writing Procedures: Drug & Device Wholesalers and HMDR - Online Study Course

Return Home:  The Designated Representative and Exemptee Blog

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

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

SkillsPlus Intl Info Blog





Enhanced by Zemanta

Wednesday, April 4, 2012

California HMDR Facility - Policies and Procedures

Policy And Procedure Writing - An Online Training Course

California HMDRFs shall have written policies and procedures.

Make sure you know how to write them, have them in place, and follow them.

CA HMDR Facilities Must Have Policies and Procedures | SkillsPlus International Info:  'via Blog this'
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 . . . "
You might also be interested in:
Buy Now: Writing Procedures: Drug and Device Wholesalers and HMDR - an online training course

Return Home:  The Designated Representative and Exemptee Blog

---------

Training program for California HMDR Exemptee license applicants

Tuesday, September 8, 2009

Writing Standard Operating Procedures - Course Announced

The Board of Pharmacy and HMDR require folks to have SOPs (standard operating procedures). If you don't have any, you should. If you're writing them, or revising them, read on. I've just learned about this new course offering by SkillsPlus International Inc., Writing Procedures: Drug and Device Wholesalers and HMDR's. 

 Here's how the course is described:
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.

Return Home: Designated Representative and Exemptee Blog 
Custom Search

From SkillsPlus International Inc.