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

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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

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• The Exemptee Institute just launched (skillsplusinfo.blogspot.com)

Policies and Procedures - California HMDR Facilities Must Have Them

• Register now to take this course: California HMDR Exemptee Training Certification Course for Home Medical Device Retailers (accepted by the California Department of Public Health - Food and Drug Branch)

Updated September 8, 2021

A link broke in the original post. Here's how to enroll in the SOP Course.

Pricing – Standard Operating Procedures Course

• $100 per student when co-purchased with our California Exemptee training course.
• Select our Writing Standard Operating Procedures (SOP) Course as an optional “add-on” course when you purchase our California HMDR Exemptee license training certification course (in other words, buy the Exemptee course, then add the optional SOP course during registration).

---  the original post follows below  ---

Policies And Procedures For California HMDR Facilities

California HMDR facilities shall have written policies and procedures.  Make sure you know how to write them, have them in place, and follow them. Your staff should be well-versed with them, and you want to make sure that they are following them.  You might want to consider taking:
Writing Procedures: Drug and Device Wholesalers and HMDR - an online training course

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 . . . "

Return Home:  The Designated Representative and Exemptee Blog

---------------

California HMDR Exemptee Training Certification Course for Home Medical Device Retailers (accepted by the California Department of Public Health - Food and Drug Branch

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

     California (earn a training affidavit):

• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training  
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

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

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute

Related articles

• CA HMDR Facilities Must Have Policies and Procedures (skillsplusinfo.blogspot.com)
• CA Pharmacy Designated Representative - Online CBT Training (skillsplusinfo.blogspot.com)
• CA Home Medical Device Retailer Exemptee License Application (skillsplusinfo.blogspot.com)
• Problems With Standard Operating Procedures? We've Got Templates (skillsplusinfo.blogspot.com)

CA HMDR Facilities Must Have Policies and Procedures

-----------------------

• California HMDR Exemptee Training Certification Course (accepted by the California Department of Public Health - Food and Drug Branch)

• California Designated Representative Training Courses (accepted by the California State Board of Pharmacy)

-----------------------

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:
Writing Procedures: Drug and Device Wholesalers and HMDR - an online training course

Return Home:  The Designated Representative and Exemptee Blog

----------------------------------------

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

     California (earn a training affidavit):

• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training - New!
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

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

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute

Related articles

• CA HMDR Facilities Must Have Policies and Procedures (skillsplusinfo.blogspot.com)
• CA Pharmacy Designated Representative - Online CBT Training (skillsplusinfo.blogspot.com)
• CA Home Medical Device Retailer Exemptee License Application (skillsplusinfo.blogspot.com)
• Problems With Standard Operating Procedures? We've Got Templates (skillsplusinfo.blogspot.com)