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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• Ready For Drug Pedigree Rules? (skillsplusinfo.blogspot.com)

Ready For Drug Pedigree Rules?

Updated November 10, 2022

The original post didn't age well.

You might also be interested in:

• Board-approved California Designated Representative courses: 

• Wholesaler Training Course 

• 3PL Training Course 

• Reverse Distributor Training Course

---  the original post follows below  ---

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:

• CA Designated Representative Certification Course by SkillsPlus International Inc.
• FL Designated Representative Training Course by SkillsPlus International Inc.

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SkillsPlus Intl Inc. - GMP Compliance Training Experts

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Online GMP Training - 21 CFR 820: Essential Elements

Updated October 28, 2018

The original post didn't age very well.

You might be interested in the current selection of SkillsPlus International Inc's FDA QSR cGMP training courses and workshops

- - -  original post follows below  - - -

Take 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.

21 CFR 820: Essential Elements on the Computer-Based Training page by SkillsPlus International Inc.

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

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FL Certified Designated Representative - Use The Most Current CIB

• Online Florida Certified Designated Representative Training Course - CDR Resource Center Training Solutions

FL CDR - Caution - Use the most current CIB | Designated Representative and Exemptee: 'via Blog this'

- - - - -

Updated May 29, 2026

Florida Certified Designated Representative Candidate Information Booklet (CDR CIB)

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. Here's how to find it.

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

In the search box, enter "candidate information booklets."  Choose English. Then click "DDC – Certified Designated Representative."

- - -  original post follows below  - - -

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.

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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, 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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e-Pedigree - CA Board of Pharmacy

• California Board of Pharmacy Designated Representative Training Courses  |  by SkillsPlus International Inc.
• Register for an online course now:
• California Designated Rep Wholesaler online training course 
• California Designated Representative 3PL online training course 
• California Designated Rep Reverse Distributor training course   
• California HMDR Exemptee online training certification course

Updated August 30, 2020

You might also be interested in:  Epedigree - Wikipedia

- - -  the original post follows below  - - -

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

CA State Board of Pharmacy - Board and Committee Meeting Agendas and Materials

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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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, 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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CA Pharmacy Designated Representative - Online CBT Training

Updated June 10, 2026

Training Program For California Designated Representative License Applicants

SkillsPlus International Inc. is the ONLY Board-approved provider of all three of the following online training programs.

• Buy now! California Designated Representative training courses for:
        Wholesalers | 3PL | Reverse Distributors
• The largest selection of Board-approved California Designated Representative online training courses. Three (3) distinct training classes for wholesalers, 3PL, reverse distributors. Earns a training affidavit suitable for your Designated Representative license application.

If you are applying for a California Designated Representative license, then you’re also going to need to include proof of required training (specifically, a training affidavit) in your license application packet. Earn a training affidavit by taking any one of our California Designated Representative training courses.

SkillsPlus International Inc.'s California Designated Representative training courses are accepted by the California State Board of Pharmacy.

We offer a very popular online training course for wholesalers, California Designated Representative Training by SkillsPlus International Inc. 

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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SkillsPlus Intl Inc. - GMP Compliance Training Experts

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

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

     California (earn a training affidavit):

• CA Designated Representative Wholesaler Training - Open 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

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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, 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

GMP-QSR Trainer Certification Public Seminar

Updated March 14, 2021

You might also be interested in our online version of the course:

GMP Trainer Awareness, Certification, & Master Trainer Course. This online self-study course leads participants through many different ways to teach cGMPs and QSRs. Learn how your class instructor thinks about delivering a training session to students, so you can repeat that training approach in your own organization.

--- original post follows below  ---

We want to see you!

Don't miss out. This popular course is almost sold out, 2011 GMP/QSR Trainer Certification Program by SkillsPlus International Inc.

There's only 1 (one) seat left. Sign up quick before we close this annual public seminar.

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Problems With Standard Operating Procedures? We've Got Templates

Are you struggling with writing standard operating procedures (SOPs)?

Then we've got your solution!

Check-out our online CBT (computer-based training) course, Writing Procedures: Drug and Device Wholesalers and HMDR.

Buy our Writing Standard Operating Procedures (SOP) Couse as an optional “add-on” course when you purchase one these courses:

• California Designated Representative Training
• California Exemptee License Training Certification

For all inquiries, give us a call:  (415) 948-5220

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Go to our website: http://www.skillsplusinc.com/

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Florida Certified Designated Representative Glossary Gadget

Updated June 7, 2021

The glossary widget is no longer available.

People also look for Florida Certified Designated Representative training for wholesalers by CDR Resource Center. Learn more today. Florida Certified Designated Representative (CDR) laws and rules examination preparation. Consulting expertise in prescription drug regulations and wholesale distribution compliance. State licensing support.

---  the original post follows below  ---

Are you studying for the Florida Certified Designated Representative (FL CDR) exam? Then use our free Florida Certified Designated Representative glossary widget (by SkillsPlus International Inc.) to search for terms and definitions. The previous hyperlink is provided because this blog page might limit how much of the widget to display. 

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CA HMDR Exemptee - Online Training and Certification

Exemptee Certification for California Home Medical Device Retailer (HMDR) - Buy Now!

This training program is intended for employees that must meet the required knowledge and training mandated by California Health and Safety Code and the associated Home Medical Device Retailer (HMDR) Licensing Program. The CA HMDR Program licenses all California and Out-of-State facilities and businesses who supply medical devices or durable medical equipment for use in the home to treat acute or chronic illnesses or injuries.

Upon successful completion of this web-based course, you'll submit your request to us for training documentation (that prompts us to complete and mail your Certificate of Completion).

California Home Medical Device Retailer (HMDR) FAQs

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