Showing posts with label program. Show all posts
Showing posts with label program. Show all posts

Tuesday, July 2, 2024

Popular cGMP Online Training Courses Updated

Popular Training Classes Updated!

Our most popular cGMP online training programs have been updated: 1) 21 CFR 211: Pure, Safe and Effective – Overview of 21 CFR 211, and 2) Proper Documentation Practices – 21 CFR 211 – Subpart J. 

Here's what a recent student says, "Awesome! Great job with the new course, it is much easier to navigate, and has a much better look and feel to it!"

Learn more about these specific courses, and more, or contact Jennifer Payne - SkillsPlus International Inc. by email.

Monday, August 1, 2022

California Designated Representative 3PL Training Course

California Designated Representative
3PL Training

Online training (approved by the California State Board of Pharmacy) for Designated Representative third-party logistics provider license applicants & their managers

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 of our California Designated Representative training courses.

About this California Designated Representative 3PL training program

  • Price:  $525 per student
  • California Designated Representative 3PL Training. Online training (approved by the California State Board of Pharmacy) for Designated Representative third-party logistics provider license applicants & their managers.
    Calif Des Rep 3PL Training
    Enter our online classroom to take the course. Available 24 x 7.
  • This course is approved by the California State Board of Pharmacy.
  • The course covers all required topics specified in the Board's license application.
  • Successful course completion earns a training affidavit accepted by the Board.
  • Nearly 10,000 students trained!

Take action!

About the Designated Representative 3PL License:

#CaliforniaDesRep #CaliforniaDesignatedRepresentative

Monday, December 13, 2021

California Designated Representative Training Course For 3PL (third-party logistics providers)

Updated May 27, 2026

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

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.

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 of our California Designated Representative training courses.

State-approved by the California State Board of Pharmacy. Nearly 10,000 students have taken one of our state license-related training classes!

This course covers all topics specified on the California Designated Representative 3PL license application form.

California Designated Representative Training Course For 3PL - Learn more >>

California Designated Representative Training Course For Third-Party Logistics Providers (3PL). Image of backlit palm trees at sunset on a California ocean beach.
California Designated Representative Training Course For 3PL (third-party logistics providers).
Enroll now!

#CaliforniaDesRep #CaliforniaDesignatedRepresentative

Thursday, August 19, 2021

California Designated Representative Training Course

Designated Representative - Wholesaler License - California State Board of Pharmacy


According to the Board, "To be licensed as a Designated Representative in California, you must satisfy the requirements under Business and Professions Code section 4053. Wholesale operations that distribute dangerous drugs or dangerous devices must be supervised by a registered pharmacist or an individual approved by the board as a designated representative. These companies may not operate unless the pharmacist or designated representative is physically on the licensed premises. To ensure proper control at all times, the board recommends that there be more than one person approved to supervise operations."

Download the Designated Representative - Wholesaler License Application Form - California State Board of Pharmacy

California Board of Pharmacy Designated Representative Wholesaler Training Course 


If you are applying for a California Designated Representative Wholesaler license, then you’re also going to need to include proof of required training in your license application packet.

The proof of required training is a form called the training affidavit. You can earn a training affidavit by taking a California Designated Representative training course approved by the Board.

Learn more and purchase this California Board of Pharmacy Designated Representative Wholesaler Training Course — presented by SkillsPlus International Inc.

  • This course is approved by the California Board of Pharmacy.
  • Designed specifically for drug/device wholesalers
  • Successful class completion earns a training affidavit accepted by the Board, to include in your Designated Representative license application.
  • More than 7,000 students have taken our courses
  • SkillsPlus International Inc. has deep experience, offering a Designated Representative training course continuously (without interruption) since 2002.
  • Our online courses run on popular devices and operating systems.

Learn more and buy California Board of Pharmacy Designated Representative Wholesaler Training Course - presented by SkillsPlus International Inc. - $525 per student. Board Approved.  Image of the Golden Gate Bridge.
Learn more and buy California Board of Pharmacy Designated Representative Wholesaler Training Course - presented by SkillsPlus International Inc. - $525 per student. Board Approved. 


Keywords and Phrases
California Board of Pharmacy; California State Board of Pharmacy; designated representative; approved; accepted; recognized; certified; training; affidavit; certificate; certification; program; course; class; webinar; seminar; workshop; event; license; application; form; online; web; eLearning; provider; vendor; seller; taught by; presented by; buy; purchase; enroll; register; wholesaler

Thursday, April 1, 2021

California Designated Representative 3PL Course

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

Updated February 27, 2026:

California Designated Representative-3PL Training Course

If you are applying for a California Designated Representative 3PL license, then you’re also going to need to include proof of required training (specifically, a training affidavit) in your California Designated Representative-3PL license application packet. Earn a training affidavit by taking any of our California Designated Representative training courses.

About this online training course:

  • Price: $525 per student
  • Enter our online classroom to take the course. Available 24 x 7.
  • This course is approved by the California State Board of Pharmacy.
  • The course covers all required topics specified in the Board's license application.
  • Successful course completion earns a training affidavit accepted by the Board, to include in your California Designated Representative 3PL license application.
  • Sign-Up Now! California Designated Representative 3PL online training course

 

California Designated Representative-3PL Training Course. Image of a glowing blue laptop against a dark background.
Register for this class, California Designated Representative-3PL Training Course.
Earns a training affidavit accepted by the California Board of Pharmacy.

Sunday, August 23, 2020

Online DRIC Training Courses - California Designated Representative Training Courses

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

Updated May 29, 2026

California Board of Pharmacy Designated Representative Training Courses for DRIC* by SkillsPlus Intl Inc.

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 (accepted by the Board) by taking any one of our courses.

SkillsPlus International Inc. proudly offers three (3) distinct Board-approved Designated Representative online training courses. Each one is specifically designed for:

  • drug/device wholesalers
  • 3PL (third-party logistics providers)
  • reverse distributors

About Our Courses:

  • All 3 of our online training programs are approved by the California State Board of Pharmacy
  • Online training classroom available 24 x 7
  • Nearly 10,000 students have taken our state license-related courses
  • Offered continuously since 2002

California Board of Pharmacy Designated Representative Training Courses for DRIC* by SkillsPlus Intl Inc.

Learn more or buy now:  California Board of Pharmacy Designated Representative Training Courses by SkillsPlus International Inc. - for wholesalers, 3PL, or reverse distributors. Board Approved!


* DRIC:

DRIC
Designated Representative In Charge (California)

Keywords and Phrases:

California Board of Pharmacy; California State Board of Pharmacy; designated representative; approved; accepted; recognized; certified; training; affidavit; certificate; certification; program; course; class; webinar; seminar; workshop; event; license; application; online; web; eLearning; provider; vendor; seller; DRIC, 2026, 2027, 2028

Tuesday, August 11, 2020

Designated Representative - Wholesaler License - California State Board of Pharmacy

Updated June 4, 2026

Designated Representative - Wholesaler License - California State Board of Pharmacy


According to the Board, "To be licensed as a Designated Representative in California, you must satisfy the requirements under Business and Professions Code section 4053. Wholesale operations that distribute dangerous drugs or dangerous devices must be supervised by a registered pharmacist or an individual approved by the board as a designated representative. These companies may not operate unless the pharmacist or designated representative is physically on the licensed premises. To ensure proper control at all times, the board recommends that there be more than one person approved to supervise operations."

Download the Designated Representative - Wholesaler License Application Form - California State Board of Pharmacy

California Board of Pharmacy Designated Representative Wholesaler Training Course 


If you are applying for a California Designated Representative Wholesaler license, then you’re also going to need to include proof of required training in your license application packet.

The proof of required training is a form called the training affidavit. You can earn a training affidavit by taking a California Designated Representative training course approved by the Board.

Learn more and enroll in California Board of Pharmacy Designated Representative Wholesaler Training Course — presented by SkillsPlus International Inc.

  • This course is approved by the California Board of Pharmacy.
  • Designed specifically for drug/device wholesalers
  • Successful class completion earns a training affidavit accepted by the Board, to include in your Designated Representative license application.
  • Nearly 10,000 students have taken our courses
  • SkillsPlus International Inc. has deep experience, offering a Designated Representative training course continuously (without interruption) since 2002.
  • Our online courses run on popular devices and operating systems.

Learn more and buy California Board of Pharmacy Designated Representative Wholesaler Training Course - presented by SkillsPlus International Inc. - $525 per student. Board Approved.


Keywords and Phrases
California Board of Pharmacy; California State Board of Pharmacy; designated representative; approved; accepted; recognized; certified; training; affidavit; certificate; certification; program; course; class; webinar; seminar; workshop; event; license; application; form; online; web; eLearning; provider; vendor; seller; taught by; presented by; buy; purchase; enroll; register; wholesaler; 2026; 2027; 2028

Wednesday, July 15, 2020

Designated Representative - 3PL License - California State Board of Pharmacy

SkillsPlus International Inc. is the ONLY Board-approved provider of all three of the following online training programs.
Updated July 26, 2026

Designated Representative - 3PL License - California State Board of Pharmacy


According to the Board, "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."

Download the Designated Representative - 3PL License Application Form - California State Board of Pharmacy

California Board of Pharmacy Designated Representative 3PL Training Course 


If you are applying for a California Designated Representative 3PL license, then you’re also going to need to include proof of required training in your license application packet.

The proof of required training is a form called the training affidavit. You can earn a training affidavit by taking a California Designated Representative training course approved by the Board.

Learn more and enroll in California Board of Pharmacy Designated Representative 3PL Training Course — presented by SkillsPlus International Inc.

  • This course is approved by the California Board of Pharmacy.
  • Designed specifically for third-party logistics providers (3PL)
  • Successful class completion earns a training affidavit accepted by the Board, to include in your Designated Representative license application.
  • Nearly 10,000 students have taken our courses
  • SkillsPlus International Inc. has deep experience, offering a Designated Representative training course continuously (without interruption) since 2002.
  • Our online courses run on popular devices and operating systems.

California Board of Pharmacy Designated Representative 3PL Training Course - presented by SkillsPlus International Inc. - $525 per student. Board Approved.
Learn more and buy California Board of Pharmacy Designated Representative 3PL Training Course - presented by SkillsPlus International Inc. - $525 per student. Board Approved. 

Keywords and Phrases
California Board of Pharmacy; California State Board of Pharmacy; designated representative; approved; accepted; recognized; certified; training; affidavit; certificate; certification; program; course; class; webinar; seminar; workshop; event; license; application; form; online; web; eLearning; provider; vendor; seller; taught by; presented by; buy; purchase; enroll; register; 3PL; third-party logistics provider

Monday, July 13, 2020

HMDR Exemptee Application: CDPH 8695

California Department of Public Health (CDPH)— Food and Drug Branch — HMDR Exemptee Application: CDPH 8695 for home medical device retailers


  • Register to take California HMDR Exemptee Certification Training — an online training class presented by SkillsPlus International Inc.  - - -  $525 per student. No extra fees to retake quizzes. Earns a course completion certificate accepted by the CDPH.

  • Download The HMDR Exemptee Application


    HMDR Exemptee Training Certification


    If you’re looking for, or need, the Exemptee application form, then you might also need a California HMDR Exemptee Training Certification Course. The Exemptee application process requires submitting proof that you’ve taken a class that covers required training topics specified on the Exemptee application.

    Upon successful completion of California HMDR Exemptee Training — presented by SkillsPlus International Inc. you’ll earn a course completion certificate accepted by the CDPH, to include with your HMDR Exemptee application packet. This course is approved by the CDPH.



    FAQ - California HMDR Exemptee Training

    Question: Who offers California HMDR Exemptee Training Certification?
    Answer: SkillsPlus International Inc. is a highly recommended provider of California Exemptee certified training for home medical device retailers (HMDR).

    Keywords & Phrases
    California Department of Public Health. Food and Drug Branch. Home Medical Device Retail. Home Medical Device Retailer. #HMDR #HME #DME #HMDRexemptee #Exemptee #accepted #approved #certified #online #web #training #program #certificate #certification #course #class #webinar #seminar #workshop #event #provider #vendor #seller #presenter #registration #enroll #register #buy #purchase

    Saturday, July 11, 2020

    Pharmaceutical Quality Resources Updated - FDA.gov

    Pharmaceutical Quality Resources Updated - FDA.gov


    The content on the FDA webpage mentioned above was recently updated.

    It's a nice landing page of jump off points for most things related to quality.

    If you need an overview:

    "This  white paper provides additional background regarding OPQ and the FDA’s oversight of pharmaceutical quality."

    Return to SkillsPlus International Info Blog - Home

    SkillsPlus Intl Inc. - The Best GMP Training & cGMP Training Around
    Root Cause Analysis - GMP Training



     

    Tuesday, July 7, 2020

    Designated Representative License Application - California State Board of Pharmacy

    Designated Representative - California Board of Pharmacy - License Application Forms

    Here's where to find the Board's collection of California Designated Representative personal license application forms:
    • Wholesaler/Non-Resident Wholesaler
    • 3PL (third-party logistics provider)
    • Reverse Distributor

    California Board of Pharmacy Designated Representative Training Course(s)

    If you are applying for a California Designated Representative license, you're also going to need training specified by the Board.

    A complete California Designated Representative license application consists of several forms and documents. The Board requires proof of training documentation, specifically, a training affidavit. A training affidavit is typically provided by a training company upon successful course completion.

    Here's how to learn more and register for a Board-approved California Board of Pharmacy Designated Representative training course (wholesaler, 3PL, reverse distributor). Presented by SkillsPlus International Inc. Board approved. Earns a training affidavit accepted by the Board. Online course pricing starts from $525 per student.

    Here's how to learn more and register for a Board-approved California Board of Pharmacy Designated Representative training course (wholesaler, 3PL, reverse distributor). Presented by SkillsPlus International Inc. Board approved. Earns a training affidavit accepted by the Board. Online course pricing starts from $525 per student.
    Here's how to learn more and register for a Board-approved California Board of Pharmacy Designated Representative training course (wholesaler, 3PL, reverse distributor). Presented by SkillsPlus International Inc. Board approved. Earns a training affidavit accepted by the Board. Online course pricing starts from $525 per student.


    Keywords and Phrases
    California Board of Pharmacy; California State Board of Pharmacy; designated representative; approved; accepted; recognized; certified; training; affidavit; certificate; certification; program; course; class; webinar; seminar; workshop; event; license; application; form; online; web; eLearning; provider; vendor; seller; taught by; presented by; buy; purchase; enroll; register

    Wednesday, April 1, 2020

    The Most Popular GMP Courses Taught By SkillsPlus International Inc.

    SkillsPlus International Inc. was originally incorporated in 1991. While serving the needs of over 500 clients and customers world-wide, it is our mission to provide quality training and consulting services that meet the needs of the client organization.

    Allan Dewes, President of SkillsPlus International Inc., possesses over 30 years experience in identifying training needs, and creating and delivering practical, cost-effective training solutions for CGMP, GCP, GLP, QSR, management, and supervisory development.  Mr. Dewes and his training team facilitate classes for all levels of the organization.  

    What follows below is a small selection of our most popular cGMP training courses.


    Root Cause Analysis & Deviation Investigation Report Writing


    You asked for it, so we delivered!

    The most popular class with Allan Dewes, "Root Cause Analysis and Investigation Report Writing" is now available as an online self-study course. In 3-1/2 hours you'll learn about the tools used to conduct a thorough deviation investigation. You'll also learn great tips and get clear guidance on how to write a deviation investigation report. This class is not just theory and offers clear examples. Private email-based coaching is also available.

    Pricing | Questions? - Call us (415) 948-5220


    About The Coaching Option (an advanced option) 


    This optional purchase enables the student to practice each tool or report section. Each item is submitted to Allan for his review and evaluation. The student receives feedback. The purchase buys the student 4-hours of email-based coaching from Allan. Additional 4-hour blocks can be purchased if needed.




    GMP Trainer Awareness, Certification, and Master Trainer Courses


    This online self-study course leads participants through many different ways to teach cGMPs and QSRs. Learn what a class instructor thinks while delivering a training session to students, so you can repeat that training approach in your own organization. 

    Pricing | Questions? - Call us (415) 948-5220

    How This Course Is Implemented


    This course is implemented in three phases: Awareness, Certification, and Master Trainer. This is NOT a public seminar workshop. Our public seminar was so popular; we turned it into an online self-study course that fits into your busy schedule.

    GMP Trainer Awareness – Students view presentations covering the course objectives below.

    GMP Trainer Certification – Students view the “Awareness” presentations. Students then prepare elements of a training session demonstrating the application of the content taught in the awareness course, or in some cases, capture and submit video segments of an actual or practice training session. All information submitted will be reviewed and critiqued by a team of Master Trainers. This course is taken simultaneously with the Awareness course.

    GMP Master Trainer – Learn GMP content to assure you know the basic GMP rules. This phase of the program is under development.

    In this course, you will learn how to:
    • Apply a Participant Centered Approach to training
    • Write course objectives
    • Development a course assessment
    • Describe the difference between ice breakers and activities
    • Describe and develop ice breakers for a class
    • Describe and develop activities for a class
    • Explain the role of the instructor during activities
    • Develop an activity debriefing strategy
    • Describe various strategies for forming groups
    • Design a course presentation
    • Identify and demonstrate effective presentation skills
    • Develop stories for a class and how to deliver the story
    • Develop discussion questions
    • Develop and implement discussion follow-up strategies
    • Demonstrate the management of disruptive behavior
    • Identify the elements of a course assessment validation plan
    • Identify the elements of a course evaluation form
    • Develop a course evaluation form



    GMP eLearning - Online  Courses


    Current Good Manufacturing Practice Training: A New Generation Series - CGMP Online Courses


    Ask yourself these three questions:

    1. Do you need to conduct CGMP Training on a limited budget? 
    2. Do you want employees to learn the CGMPs from an expert using real examples? 
    3. Do you need CGMP Training resources suitable for multiple levels of the organization?

    If you answered YES to any of these three questions then you should take a look at the courses below:

    • 21CFR211 - Learn the highlights of the Current Good Manufacturing Practice Regulations.
    • Your Personal Responsibilities - Part B. Review the requirements for personnel working in the pharmaceutical industry.
    • Foundation to Facility - Part C. Dive into the requirements for the design, cleaning & maintenance of a facility.
    • Maintaining Compliant Equipment Practices - Part D. Examine the requirements for the design, cleaning & maintenance of equipment.
    • Supplier to Plant - Part E. Explore the requirements for the receipt, storage and use of all components.
    • Plan to Production - Part F. Review the requirements for production process controls and validation.
    • Plant to Patient - Part G, H, & K. Examine the requirements for packaging, labeling, warehousing and distribution.
    • Laboratory to Release - Part I. Dive into the requirements for laboratory controls, method validation, stability and more!
    • Proper Documentation Practices - Part J. Examine the requirements for proper paper and electronic documentation practices.

    Return to SkillsPlus International Info Blog - Home

    SkillsPlus Intl Inc. - The Best GMP Training & cGMP Training Around
    Free GMP Training Tips
    Root Cause Analysis - GMP Training
    Deviation Investigation Report Writing - GMP Training
    Qualstar Simulation - Advanced GMP Training That's Fun!

     

    Saturday, March 21, 2020

    California Designated Representative Courses

    California Designated Representative

    California Designated Representative Courses for:
          Wholesalers | 3PL | Reverse Distributors

    • online training courses available 24 x7
    • approved by the California State Board of Pharmacy
    • 3 distinct courses for:  wholesalers, 3PL, reverse distributor
    • prices start at $525 per student
    • earns a training affidavit recognized by the Board
    • more than 7,000 students have taken our state license-related training programs
    California Designated Representative Courses - for wholesalers, 3PL, reverse distributors
    California Designated Representative Courses - for wholesalers, 3PL, reverse distributors

    Wednesday, June 27, 2018

    California Designated Representative Training Courses

    California Designated Representative Training Courses

    SkillsPlus International Inc. is the ONLY Board-approved provider of all three of the following online training programs.
    • Buy a course now for: Wholesalers | 3PL | Reverse Distributors
    • SkillsPlus International Inc.'s California Designated Representative training courses are accepted by the California State Board of Pharmacy.
    • Earn a training affidavit (accepted by the California Board of Pharmacy)

    What is the California Designated Representative training affidavit?

    • The California Designated Representative license application forms are lengthy and involved.  A lot of information needs to be provided, and a lot of documents must be submitted.
    • One document that needs to be submitted is the "Training Affidavit."
    • The training affidavit is one of many forms that makes up the complete license application package.  In order to get a training affidavit, the license applicant needs to go through a training program.  The training program is commonly sold as a training course, training class, or training seminar.  Upon successful completion of a training course, the course administrator issues proof of completion, in the form of a training affidavit.

    How To Earn A Training Affidavit

    1. Find a training program that is accepted by the California Board of Pharmacy.  We suggest our California Designated Representative training courses.
    • Our courses are available online 24 x7
    • We have a long track record. We've trained more than 5,000 students.
    2. Make sure you take the correct course that's appropriate for your license application.  Specifically, there are several types of California Designated Representative license applications (including, but not limited to):
    • California Designated Representative - Wholesaler
    • California Designated Representative - 3PL (third-party logistics provider)
    • California Designated Representative - Reverse Distributor
    3. Complete the training program to earn a training affidavit. Include the training affidavit in your license application package.

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

         California (earn a training affidavit - accepted by the California Board of Pharmacy):
         Florida:

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

         California (earn a training completion certificate - accepted by the CA Dept of Public Health):

    Wednesday, March 29, 2017

    FDA Office of Regulatory Affairs Realignment to Begin in May | RAPS

    Read the full article: FDA Office of Regulatory Affairs Realignment to Begin in May | RAPS:

    "FDA spokesperson Lyndsay Meyer confirmed to Focus that the long-planned program alignment for ORA will kick off on 15 May 2017, saying the office "will be moving away from a geographic (regional) management model and align with a commodity-based program structure. All regional food and drug directors (RFDDs), regional directors and regional staff will transition into other positions in ORA.""

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    SkillsPlus Intl Inc. - The Best GMP Training & cGMP Training Around
    Free GMP Training Tips
    Root Cause Analysis - GMP Training
    Deviation Investigation Report Writing - GMP Training
    Qualstar Simulation - Advanced GMP Training That's Fun!

     

    Tuesday, September 16, 2014

    Foresight is 20/20: The Need For Pharmaceutical Companies to Implement Robust Anti-Corruption Programs - Pharmaceutical Compliance Monitor

    Updated September 4, 2024

    Unfortunately, the original link broke.

    ---  the original post follows below  ---

    More insights in the full article: Foresight is 20/20: The Need For Pharmaceutical Companies to Implement Robust Anti-Corruption Programs - Pharmaceutical Compliance Monitor:

    "In the wake of the recent FCPA enforcement activity, the government has signaled its renewed attention to pharmaceutical companies. It is therefore imperative that pharmaceutical companies doing business abroad assess their individual risks, develop compliance goals, and create and implement a comprehensive compliance program that evolves in conjunction their risk profile and ever-changing enforcement trends."

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    Friday, September 12, 2014

    FDA could be source of innovation, Hamburg says - Denver Business Journal


    Read the full article: FDA could be source of innovation, Hamburg says - Denver Business Journal:

    "The FDA, in the course of approving new drugs and devices and overseeing their safety and effectiveness, gains broad knowledge of what companies are doing, what researchers are discovering about disease and how that relates to medical outcomes.

    Hamburg’s vision is for the FDA to use that position to help researchers and companies make more effective new treatments and prove new medical advances more quickly, she said.

    “We have a lot more to offer than has historically been appreciated,” said Hamburg, U.S. Commissioner of Food and Drugs since 2009. “The regulator has a very different role than the innovator or the academic researcher, but we can be a very effective partner for both.”"

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    SkillsPlus Intl Inc. - The Best GMP & QSR Compliance Training Around

    Tuesday, July 22, 2014

    FDA Abroad - Pharmaceutical Executive

    Updated June 4, 2025

    Sadly, the original link broke.

    --  the original post follows below ---

    Read the full article: FDA Abroad - Pharmaceutical Executive:

    "In India, America's second largest global source of API and finished drug products, some 1,965 manufacturing facilities export to the US, but only around 600 sites are registered with CDER, said Atul Agrawal, supervisory consumer safety officer at FDA's India office. Drug manufacturing capability in India doubled to represent 12% of total US drug imports in 2012, up from 6% in 2008. "India is a major player in the prescription drugs Americans take on a daily basis," said Agrawal, much to the envy of Chinese nationals everywhere. And yet, FDA's operation in India currently consists of five full-time Americans, and two locally employed staffers, spread across two offices, one in New Delhi and one in Mumbai."

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    Monday, June 23, 2014

    Pure Food and Drug Act passes in Congress, June 23, 1906 - POLITICO.com

    English: Theodore Roosevelt, circa 1902
    English: Theodore Roosevelt, circa 1902 (Photo credit: Wikipedia)
    Read the full article: Pure Food and Drug Act passes in Congress, June 23, 1906 - Andrew Glass - POLITICO.com:

    "On this day in 1906, the Pure Food and Drug Act cleared a hurdle toward its passage when the House and Senate both endorsed a joint conference committee report favoring the bill. The House vote was 240-17. President Theodore Roosevelt signed the landmark Progressive Era legislation into law on June 30.

    The statute for the first time regulated food and drugs that moved in interstate commerce and forbade the manufacture, sale or transportation of poisonous patent medicines. It arose, with strong White House support, in the wake of exposés by such muckrakers as Upton Sinclair and Samuel Hopkins Adams."

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    SkillsPlus Intl Inc. - The Best GMP & QSR Compliance Training Around

    Friday, June 6, 2014

    SecuringIndustry.com - USP starts field trials of FDA fake drug screening device

    Read the full article: SecuringIndustry.com - USP starts field trials of FDA fake drug screening device:

    "The US Pharmacopeial Convention has started field testing a new low-cost screening device designed to detect counterfeit and poor quality medicines quickly.

    The handheld CD-3+ unit - originally developed by the US Food and Drug Administration (FDA) - uses multiple light sources to look at packaging using different wavelengths and provide images that can be interpreted by the user to differentiate between genuine and falsified medicines. The approach may also be applicable to individual tablets."

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