FDA Launches the Digital Health Center of Excellence - FDA.gov

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

According to the FDA press release:

"Today, the U.S. Food and Drug Administration announced it is launching the Digital Health Center of Excellence within the Center for Devices and Radiological Health (CDRH). The launch of the Digital Health Center of Excellence is an important step in furthering the agency’s overarching dedication to the advancement of digital health technology, including mobile health devices, Software as a Medical Device (SaMD), wearables when used as a medical device, and technologies used to study medical products.

“Establishing the Digital Health Center of Excellence is part of the FDA’s work to ensure that the most cutting-edge digital health technologies are rapidly developed and reviewed in the U.S.,” said FDA Commissioner Stephen M. Hahn, M.D. “Today’s announcement marks the next stage in applying a comprehensive approach to digital health technology to realize its full potential to empower consumers to make better-informed decisions about their own health and provide new options for facilitating prevention, early diagnosis of life-threatening diseases, and management of chronic conditions outside of traditional care settings. The Digital Health Center of Excellence will provide centralized expertise and serve as a resource for digital health technologies and policy for digital health innovators, the public, and FDA staff.”"

Read the full press release: FDA Launches the Digital Health Center of Excellence - FDA.gov

Go to the: Digital Health Center of Excellence - FDA.gov

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!

 

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

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

In 8 one-hour segments learn what the experts know about the CGMPs for Pharmaceutical and Biotech manufacturing. 

Learn more, and view the details about CGMP Training: A New Generation Series

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.

FDA GMP QSR cGMP Training - online training classes by SkillsPlus International Inc.

Return to SkillsPlus International Info Blog - Home

Provisions of the Executive Order Procurement Requirements for Products Made in the U.S.

• FDA cGMP QSR GMP Training - online training courses by SkillsPlus International Inc.

Read the full source article:  What You Need to Know about President Trump’s Executive Order to Strengthen the Domestic Supply Chain for Essential Drugs and Medical Devices - The National Law Review

According to the article:

"On August 6, 2020, President Trump signed an Executive Order (“Order”) to ensure essential medicines, medical countermeasures, and critical inputs are made in the United States.  The President recognized that reliable domestic supply chains for Essential Medicines, Medical Countermeasures, and Critical Inputs are necessary for the preparedness and protection of United States citizens."

Return to SkillsPlus International Info Blog - Home

---------

FDA cGMP QSR GMP Training - online training courses by SkillsPlus International Inc.

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!