Monday, July 26, 2021

California Designated Representative 3PL Training Course

California Designated Representative Third-Party Logistics (3PL) Training Course

The Designated Representative-3PL protects the public health and safety in the handling, storage, warehousing, distribution, and shipment of dangerous drugs and dangerous devices in the third-party logistics provider’s place of business. 

California Designated Representative Third-Party Logistics (3PL) Training Course. Image of a lighthouse on the California coast.
Purchase now to take this California
Designated Representative 3PL
training course
.

3PL Course Topics

Importantly, this course covers all topics specified on the California Designated Representative license application form, and focuses on knowledge and understanding of:

  • California and federal laws regarding the distribution of: dangerous drugs and dangerous devices, and controlled substances
  • quality control systems
  • United States Pharmacopoeia standards or federal Food and Drug Administration standards relating to the safe storage, handling and transport of dangerous drugs and dangerous devices

Course Details

  • Students may complete the course from a personal computer, laptop, iPad, and may complete the course from multiple devices at work or at home. In other words, study wherever you like.
  • Students are prompted to resume where they left-off from the last training session.
  • Quizzes started and not yet finished can be saved to the next sign-in session. In addition, there are no extra fees to retake the quizzes.
  • Course takes approximately 7-8 hours depending on the speed the student responds to quiz questions.
  • Course fee: $525. Purchase now to take this California Designated Representative 3PL training course.
  • Above all, if you have questions, please e-mail us for the fastest response at jennifer.payne@skillsplusinc.com

Benefits of Our California Designated Representative 3PL Course

  • Online internet-based e-learning, to fit your schedule, 365 x 24 x 7. Come and go as needed. What is e-learning? Therefore, our courses are convenient and flexible.
  • We’ve added something new, closed captioning. Students can read what the course instructor is teaching. This feature helps ESL (English as a second language) students, and hard of hearing students. Similarly, this makes our courses more accessible.
  • Nearly 10,000 students have taken our state license-related courses. In other words, our courses are very popular!
  • We have offered a California Designated Representative training course continuously since 2002. Therefore, we have a long record of experience.

Return Home:  The Designated Representative and Exemptee Blog

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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):

Monday, July 19, 2021

New DSCSA Related Guidance Docs

According to this FDA In Brief quote by Donald D. Ashley, J.D., Director of the Office of Compliance for FDA's Center for Drug Evaluation and Research:

"Ensuring the quality of prescription drugs and safeguarding the integrity of pharmaceutical distribution are crucial roles the FDA plays in protecting the health of the American public. Illegitimate and unsafe products must be kept out of the U.S. drug supply chain.

Since 2013, when the FDA began phasing in new requirements added by the Drug Supply Chain Security Act (DSCSA), we have helped create a supply chain that is better at preventing and detecting the introduction of illegitimate products. The new requirements can also enable stakeholders and the FDA to respond rapidly when such products are found.

To help our stakeholders understand these requirements, we are issuing guidance documents intended to assist trading partners in complying with the law and achieving a safer, more secure and more trusted drug supply chain. We are also soliciting feedback for further improving the way our drug supply chain operates within the DSCSA framework. We view these guidance recommendations as an important part of implementing the robust enhanced system envisioned under DSCSA.

We look forward to continuing open conversations on DSCSA-related issues and providing future guidance to stakeholders as part of our efforts to protect American patients and the drug supply chain we all rely on."

Read more and see the links to the four (4) newly added guidance documents: 
FDA In Brief: FDA provides new guidance to further enhance the security of prescription drugs in the U.S. supply chain - FDA.gov

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):

Wednesday, July 14, 2021

Wholesaler Self-Assessments Due Before July 1

Self-Assessment Forms

California State Board of Pharmacy

Has your facility completed a self-assessment form? 

PICs are required to complete a self-assessment before July 1 of each odd-numbered year. 

View the current self-assessment forms and updated self-assessment draft forms. Although licensees are required to complete currently adopted self-assessment forms, either the current or draft forms are acceptable.

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):

Tuesday, July 6, 2021

FDA Issues Safety Communication About Philips Recall - Sleep Review

According to the article:

"The US Food and Drug Administration (FDA) is alerting people who use Philips Respironics ventilators, BiPAP, and CPAP machines and their health care providers that Philips Respironics has recalled certain devices (see table below) due to potential health risks. The polyester-based polyurethane (PE-PUR) sound abatement foam, which is used to reduce sound and vibration in these affected devices, may break down and potentially enter the device’s air pathway. If this occurs, black debris from the foam or certain chemicals released into the device’s air pathway may be inhaled or swallowed by the person using the device.

If you use one of these affected devices (see table below), talk to your health care provider to decide on a suitable treatment for your condition and follow the recommendations listed below.

Philips Respironics is recalling the following affected devices manufactured between 2009 and April 26, 2021."

Read the full source article:  FDA Issues Safety Communication About Philips Recall - Sleep Review

Related news:


- - -

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):

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From SkillsPlus International Inc.