Saturday, December 28, 2019

Retail Sales of Tobacco Products - FDA.gov

Read the full article:  Retail Sales of Tobacco Products - FDA.gov

"Note:
On December 20, 2019, the President signed legislation to amend the Federal Food, Drug, and Cosmetic Act, and raise the federal minimum age of sale of tobacco products from 18 to 21 years. It is now illegal for a retailer to sell any tobacco product – including cigarettes, cigars and e-cigarettes – to anyone under 21. FDA will provide additional details on this issue as they become available."

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FDA cGMP QSR GMP online training courses by SkillsPlus Intl Inc.
FDA cGMP QSR GMP online training courses by SkillsPlus Intl Inc.


SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
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Wednesday, December 18, 2019

FDA cGMP QSR GMP Online Training Courses by SkillsPlus International Inc.

FDA cGMP QSR GMP Online Training Courses by SkillsPlus International Inc.
FDA cGMP QSR GMP Online Training Courses by SkillsPlus International Inc.


FDA cGMP QSR GMP Online Training

Benefits

  • Use in the classroom as a training video
  • Standardize content delivery
  • Reduce training expense with our online learning pricing
  • Use in one-on-one training environments
  • Make these classes a part of corrective and preventive actions 

Details

  • $50 per individual course 
  • Once a course is purchased, you'll be able to view the course one-time (within 48 hours from the time of purchase). 
  • Call us about Annual Global License pricing.

  • Interested in a course? Give us a call:  (415) 948-5220

Courses Available

  • 21 CFR 211: Pure, Safe, and Effective  - This program reviews 21 CFR 211 with the reminder that all these rules help us produce a product that is pure, safe and effective. This program is a must for new employee orientation training at all levels of the organization.
  • Documentation Practices  - This program provides a most interesting review of proper documentation practices for both paper-based and electronic record environments. 
  • Equipment and CGMPs - This topic discusses the requirements of 21 CFR211 Subpart D - Equipment, specifically the design and construction requirements for equipment including lubrication and coolants. The class addresses cleaning and maintenance requirements including automatic and electronic equipment. The class also covers the requirements for equipment identification, and required documentation.

Courses Coming Soon!

  • Buildings and Facilities (Coming 2019) - This topic provides a review of the requirements of Building and Facilities issues well beyond Subpart C, Buildings and Facilities.  This program, uses many video segments from actual plant operations to review the essential elements of this Subpart.
  • Surviving an FDA Inspection  (Coming 2019) - Learn what to expect, how to plan for an inspection, and how to behave. This program has demonstrations of interviews and different response strategies. Some are intended to be humorous, while some are common mistakes made when interacting with the FDA. Use this program to plan for your next inspection.
  • Understanding Validation  (Coming 2019) - Delve into the intricate rules and practices of validation. This course is based on guidance documents on validation. The concepts of validation are explained in simple language. This is a great introduction to validation as well as preparation for the plant's next major validation initiative.
  • Contamination Control  (Coming 2019) - This topic discusses the sources of contamination and methods to prevent contaminating products. This is a great session for new employees needing to learn about the risks and proper behaviors to controlling contamination. Use this program as part of a corrective or preventive action as a result of contamination control breaches.
  • Materials and CGMP  (Coming 2019) -  This topic traces the CGMP requirements from supplier qualification through to manufacturing and packaging. A solid review of 21 CFR 211 Subpart E, Control of Components, Drug Product Containers and Closures.
  • Organization and Personnel  (Coming 2019) -  This topic summarizes the essential elements of 21CFR211 Subpart B, Organization and Personnel. This is a great orientation to this subpart for new employees or serves as a quick refresher.
  • Production and Process Control  (Coming 2019) -  This topic provides a review of the requirements of 21 CFR 211 Subpart F, Production and Process Controls.  This program, uses many video segments from actual plant operations to review the essential elements of this Subpart.
  • Implementing A Successful Change Control Program (Coming 2019) - This program reviews the requirements of change control and components of a successful change control program.

Friday, December 13, 2019

Senate confirms oncologist Stephen Hahn as FDA commissioner - The Washington Post

Read the full article:  Senate confirms oncologist Stephen Hahn as FDA commissioner - The Washington Post

Texas doctor faces contentious issues as he assumes helm of sprawling agency

"Stephen Hahn, an oncologist and top official at MD Anderson Cancer Center, was confirmed Thursday as commissioner of the Food and Drug Administration. The Senate vote was 72 to 18.

Hahn, 59, takes over as the FDA juggles vexing political and health issues, including the Trump administration’s still-unresolved response to a surge in underage vaping over the past two years."

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
FDA cGMP QSR GMP Training Catalog & eBrochure - Courses, classes, workshops, and seminars
Who Offers Live Onsite GMP Training?
Free GMP Training Tips

The Designated Rep and Exemptee Professionals Blog
Designated Rep Certification Class
CA Designated Representative Training Program
California Designated Representative Training Program
California HMDR Exemptee Training
Exemptee Certification Class
FL CDR Exam Prep
SkillsPlus Intl Inc. - The Leader in Compliance Training
The Health, Drug, Prescription, and GMP Supersite Gift Store 

Thursday, December 12, 2019

‘Dump it down the drain’: How contaminants from prescription-drug factories pollute waterways - STAT



Read the full article:  ‘Dump it down the drain’: How contaminants from prescription-drug factories pollute waterways - STAT

According to the article:

"Over the past decade, cocktails of drugs from opioids to antidepressants have been showing up in rivers all over the U.S. Studies have detected these chemicals in the bodies of fish and aquatic insects, altering behaviors that are key to survival. Now, an investigation by STAT and Type Investigations identifies for the first time major drug companies that are likely dumping substantial quantities of drugs from their manufacturing facilities into rivers and streams."

Monday, December 9, 2019

Landmark Marijuana Legislation Moves through Congress - JDSUPRA

Read the full article:   Landmark Marijuana Legislation Moves through Congress - JDSUPRA

According to the article:
"On November 20, 2019, the House Judiciary Committee passed the Marijuana Opportunity Reinvestment and Expungement (MORE) Act of 2019. The historic bill was sponsored by House Judiciary Chairman Jerrold Nadler (D-NY) and can now move to a floor vote in the House of Representatives."

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