Showing posts with label regulations. Show all posts
Showing posts with label regulations. Show all posts

Saturday, January 1, 2022

California Designated Representative Training Courses

Updated January 1, 2026

Start your new year training now!  SkillsPlus International Inc. is the ONLY Board-approved provider of all three (3) of the following training programs. Enroll now in any one of our Board-approved California Designated Representative training courses to earn a training affidavit for your license application:

California Designated Representative Training Courses


Don't get caught flat-footed in the new year! 

Nearly 10,000 Students Have Taken Our Courses!


Here's why our online training programs are so popular and highly recommended:
  • These online training courses are designed for California Designated Representative license applicants and their managers. We make the messy regulatory requirements simple and easy to understand!
  • Earn a Board-accepted training affidavit, for your license application, by taking any one of our courses.
  • No need to schedule your training. Buy the course. Start when you’re ready! Therefore, buy now and start studying!
  • Online internet-based e-learning, easily accessed to make it possible & convenient for you to study from your home or office, in other words, study in any location!
  • Our courses involve more than just reading slides.
  • Available 365 x 24 x 7. Come and go as needed. In other words, our courses are convenient and flexible.
  • Composed of a series of self-study pre-recorded presentations that cover essential and required topics (as specified on their respective California Designated Representative license application form).
  • Designed with a follow-up quiz after each course section. When you finish, you will request your completion documents, specifically, your training affidavit.
  • 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. Therefore, our courses are more accessible.
  • Offered continuously since 2002. Therefore, we have a long record of experience.

Don't get caught flat-footed in the new year! California Designated Representative online training courses by SkillsPlus International Inc.

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Friday, December 15, 2017

FDA Guidance: Regulations Under a Mask? | Bloomberg BNA

Read the full article:  FDA Guidance: Regulations Under a Mask? | Bloomberg BNA:

"The Washington Legal Foundation, a free-market advocacy group and think tank, is charging that the Food and Drug Administration is leaning too heavily on guidance documents in lieu of regulations, undercutting the Administrative Procedure Act and causing excessive burdens on affected industries. The group said the FDA has released more than 2,000 guidance documents and draft documents, far too many for industry to keep track of."

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Thursday, November 6, 2014

It's Not Just You: FDA Regulatory Requirements Really Are Increasing | RAPS


Read the full article: It's Not Just You: FDA Regulatory Requirements Really Are Increasing | RAPS:

"According to data made available by George Mason University's Mercatus Center and analyzed by Regulatory Focus, the number of regulatory requirements imposed by the US Food and Drug Administration (FDA) increased by 15% between the years 2000 and 2012.

While regulatory professionals working with FDA needed to know just 16,329 requirements in 2000, they needed to know 18,777 in 2012, according to the data."

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Monday, November 12, 2012

Regulators, Industry Discuss Potential Impact of IMDRF

Updated June 16, 2023

The original link broke.

You might also be interested in:

---  the original post follows below  ---

The International Medical Device Regulators Forum (IMDRF) may be the newest global harmonization body.

Regulators, Industry Discuss Potential Impact of IMDRF > RAPS > News - Article View:

"Unlike GHTF, which was a blend of agency regulators and industry representatives, IMDRF relegates industry to a consultation role while keeping regulators in the drivers' seat. "After 20 years, time for a change," said Minor

This desire for accelerated change is written into the agency's mission, observed Trautman, speaking to the session by video link after an East Coast hurricane prevented her from attending in person. "The mission of the IMDRF is to strategically accelerate international medical device regulatory convergence to promote an efficient and effective regulatory model for medical devices that is responsive to emerging challenges in the sector while protecting and maximizing public health and safety," she relayed, quoting its mission statement."

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Monday, September 19, 2011

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.
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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