Tuesday, July 21, 2009

CA - Forms for Drug Wholesalers and Designated Representatives

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There will be times when you need to submit new or revised forms to the CA State Board of Pharmacy. Here's a collection of forms that might be useful to drug wholesalers, and designated representatives.

Just a tip, make sure to pay attention to the requirements for when some of these forms need to be submitted. For example, changes in the designated representative in charge need to be reported within 30 days of a change.

Go to the California Board of Pharmacy - Applications and Forms Page

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Tuesday, July 14, 2009

Watch Your Back - I mean safety!

We all do some heavy lifting from time to time, so it's critical to pay attention to back safety. Here's a useful article from the NAW, Material Handling - Do's and Don'ts. The article frames the situation in this way:
Manual handling, and the twisting and turning that occur when they perform these tasks, can lead to musculoskeletal disorders (MSDs) or cumulative disorders (CTDs), such as injuries to the back, shoulder and neck. The cumulative effect of even minor injuries of this nature can become more pronounced over time.

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Thursday, July 9, 2009

Reinforce Key Regulatory Messages - Use Posters

GMP Posters. Suitable for training and quality efforts.
Drug wholesaler designated representatives and medical device exemptees often need to recruit the help of staff around them to ensure the company complies with regulatory requirements.

If you're looking to make your company's training or quality programs more robust, consider using posters to reinforce your key messages.

SkillsPlus International Inc. announces, "Poster! Posters! and More Posters!" in the release of their brand new GMP poster series, SkillsPlus International Inc. - GMP Good Manufacturing Practice and QSR Quality System Regulation - Large Posters (23" x 35"). Alternatively, you can also scan their offerings in the SkillsPlus GMP Poster Catalog. I find these posters strikingly beautiful, and convey very simple and understandable messages.

By the way, if you think these posters don't apply to your work situation, I encourage you to think twice. Many of them apply to many diverse work settings. Folks have been clamoring for more work-related posters, so it's great to see these new additions to poster offerings. Check it out!

Other GMP posters I've found on the web:
ISPE GMP Posters
Compliance Insight GMP Motivational Posters

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Tuesday, July 7, 2009

CA HMDR FAQs

The Sumerian god Ningizzida was the patron of ...Image via Wikipedia
Here's something you might find helpful, The CA Home Medical Device Retailer (HMDR) licensing program Frequently Asked Questions (FAQs)

Here are the questions that are answered:
  1. What is an HMDR business and who needs an HMDR license from the DHS, Food and Drug Branch?
  2. Where can I get an HMDR license application and what are the fees?
  3. Are there exceptions to the kinds of facilities that are required to have an HMDR license?
  4. What is the licensing process and how long does the process take?
  5. Can I operate my HMDR business without a valid license?
  6. After my facility is inspected, how long afterwards must I wait for my facility license?
  7. If my facility fails to meet compliance standards, what happens?
  8. If I move or sell my business, can my license be transferred?
  9. What is a Temporary License, and what are the criteria for receiving one?
  10. What are dangerous or “legend” devices?
  11. I wish to dispense legend medical devices from my HMDR. Do I need a special license?
  12. How can I obtain an HMDR exemptee license?
  13. Can I obtain an exemptee license without working at a HMDR facility?
  14. What about HMDR renewal inspections? How frequently are they conducted, and what are some common violations found?
  15. How can I get a copy of the HMDR Law and/or guidance on requirements?
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