Tag Archives: 3PL

California Designated Representative Training Programs

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Find California Designated Representative Training Programs – Earn a training affidavit

Question:  Who offers California Designated Representative training courses?

Answer:  SkillsPlus International Inc. offers these popular online classes:

Go to DREprof.com: The Designated Representative and Exemptee Training Website

New ATA report takes a deep dive into the ongoing truck driver shortage – Logistics Management

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“So, what about those future numbers? You may want to cover your eyes, as they are not pretty. According to the ATA, the driver shortage is projected to hit 50,000 by the end of 2017, with the possibility, if things remain the same, that the number could exceed 174,000 by 2026.”

Source: New ATA report takes a deep dive into the ongoing truck driver shortage – Logistics Management

Go to DREprof.com: The Designated Representative and Exemptee Training Website

FDA Clarifies DSCSA Entities And Trading Partners

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Entities & Trading Partners Defined Under The DSCSA

“The Food and Drug Administration (FDA or the Agency) is issuing this guidance to assist industry and State and local governments in understanding how to categorize the entities in the drug supply chain in accordance with the Drug Supply Chain Security Act (DSCSA). DSCSA establishes product tracing requirements for certain trading partners in the drug supply chain, including manufacturers, repackagers, wholesale distributors, and dispensers. DSCSA also requires that trading partners of manufacturers, wholesale distributors, dispensers, and repackagers must meet the applicable requirements for being “authorized trading partners.” DSCSA also requires FDA to issue regulations that establish Federal standards for the licensing of wholesale drug distributors (WDDs) and third-party logistics providers (3PLs). The Agency is currently drafting these regulations. This guidance, when finalized, will explain FDA’s current thinking on how licensing and certain other requirements apply to entities that may be considered trading partners in the drug supply chain.

This guidance is intended to (1) assist industry and State and local governments in understanding the applicability of DSCSA requirements to the various types of entities that take part in the distribution of prescription drugs in the United States, and (2) help clarify for industry whether they are engaged in activities that require licensure and annual reporting, as well as other requirements related to being an authorized trading partner in the drug supply chain. The guidance does not address all requirements described in DSCSA, but is limited to describing the activities that would determine what type of trading partner an entity may be and the applicable requirements under DSCSA.”

Source:
Identifying Trading Partners Under the Drug Supply Chain Security Act – Guidance for Industry – DRAFT GUIDANCE (PDF)

Go to DREprof.com: The Designated Representative and Exemptee Training Website

California Third-Party Logistics Provider License – 3PL

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California 3PL Provider License – CA Board of Pharmacy

ICYMI – The California Board of Pharmacy oversees 3PL providers and their Designated Representative-3PL.

“Third-party logistics provider” means an entity that provides or coordinates warehousing or other logistics services for a dangerous drug or dangerous device in intrastate or interstate commerce on behalf of a manufacturer, wholesaler, or dispenser of the dangerous drug or dangerous device, but does not take ownership of the dangerous drug or dangerous device, nor have responsibility to direct its sale or disposition. … The Designated Representative-3PL Responsible Manager must file a separate application with the board if he or she is not already licensed as a Designated Representative-3PL in California. The application form is available by selecting the following link Designated Representative-3PL Application.

Source:  Third-Party Logistics Provider/Nonresident Third-Party Logistics Provider License – California Board of Pharmacy

You might also be interested in:  Designated Representative – 3PL License – California Board of Pharmacy

Go to DREprof.com: The Designated Representative and Exemptee Training Website

California Designated Representative-3PL – Training Program

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Earn a training affidavit. Training program for CA Designated Representative-3PL license applicants.

The California Board of Pharmacy says,

“To be licensed as a Designated Representative – 3PL in California, you must satisfy the requirements under Business and Professions Code section 4053.1. Each place of business of a third-party logistics provider shall be supervised and managed by a responsible manager. The responsible manager shall be responsible for the compliance of the place of business with state and federal laws governing third-party logistics providers and with the third-party logistics provider’s customer specifications, except where the customer’s specifications conflict with state or federal laws. The responsible manager shall maintain an active license as a designated representative-3PL with the board at all times during which he or she is designated as the responsible manager.”

A complete license application package includes submission of a training affidavit, as proof of training program completion.

Go to DREprof.com: The Designated Representative and Exemptee Training Website

RK Logistics Group Earns CA Board of Pharmacy Certification – PR Newswire

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“for its Fremont, CA headquarters facility where it provides full-spectrum supply chain support solutions in the Tri-Valley and San Jose for hi-tech, pharmaceutical and biomedical devices firms”

Source: RK Logistics Group Earns CA Board of Pharmacy Certification – PR Newswire

Go to DREprof.com: The Designated Representative and Exemptee Training Website

Self-Assessment Forms – California State Board of Pharmacy

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Self-Assessment Forms – CA St Board of Pharmacy

 

“The assessment shall be performed before July 1 of every odd-numbered year. The self-assessment forms must remain on-site at the facility. Only submit the form to the board if requested by board staff.  The board is in the process of updating the Self-Assessment forms through a formal rulemaking.  The updates include references to statutory and regulatory changes that occurred between 2014 and 2016.  The last time the forms were formally updated was 2014.Current regulation requires a pharmacy or wholesaler to complete the 2014 version of the Self-Assessment form.  Please be advised, however, the board will accept completion of either the 2014 version OR the 2016 version.  The latter version is likely to be a more helpful assessment to the pharmacy or wholesaler completing it.”

Source: Self-Assessment Forms – California State Board of Pharmacy

Go to DREprof.com: The Designated Representative and Exemptee Training Website

GS1 US Workshop Series Offers Pharmaceutical Industry Professionals DSCSA Implementation Assistance | Healthcare Packaging

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“Specifically, how to mark pharmaceutical products with a National Drug Code (NDC), serial number, lot number, and expiration date in both machine-readable and human-readable format will be covered, as will the use of GS1 identifiers, application identifiers, and data carriers.”

Read the full article (Source): GS1 US Workshop Series Offers Pharmaceutical Industry Professionals DSCSA Implementation Assistance | Healthcare Packaging

Go to DREprof.com: The Designated Representative and Exemptee Training Website

Training affidavit for CA Designated Representative license applicants

Training affidavit for CA Designated Representative license applicants

Training Affidavit For California Designated Representatives

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Training affidavit for CA Designated Representative license applicants

Training affidavit for CA Designated Representative license applicants

Looking for a California Designated Representative training program?

YOU NEED A TRAINING AFFIDAVIT – If you need a training affidavit as proof of completing a training program, as part of your California Designated Representative or  CA Designated Representative-3PL license application, then keep reading.

WE CAN HELP YOU
Buy one of our courses:  Designated Representative Training Programs by SkillsPlus Intl Inc.  –  These online self-study courses are $525 per student, and they are approved by the California Board of Pharmacy. Learn more about our CA Designated Representative training programs. When you’ve successfully completed a program, simply request your copies of completed training affidavits.

Go to DREprof.com: The Designated Representative and Exemptee Training Website

How to Become a California Board of Pharmacy Designated Representative | StupidLicense.com

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“Some companies need more than one designated representative. That is because every moment that the business is operating, at least one rep must be there. So with vacations and days off and maybe multiple shifts, it’s not possible in many cases for one of these wholesale drug or device companies to fulfill their requirements with only one designated rep.”

Read the full article:  Source: How to Become a California Board of Pharmacy Designated Representative | StupidLicense.com

Go to DREprof.com: The Designated Representative and Exemptee Training Website

Designated Representative and Exemptee Training

Training Certification Class for Designated Representative and Exemptee license applicants