Showing posts with label qsr. Show all posts
Showing posts with label qsr. Show all posts

Tuesday, March 2, 2021

Drug industry pushes FDA to solve growing inspection backlog - Politico

 AD - FDA GMP Online Training Courses by SkillsPlus Intl Inc. - AD

I had to read this snippet very carefully, and re-read it several times to make sure I completely understood the statistics reported. I suggest you do the same.

According to the article:

"From March through September, FDA inspected just three plants outside the U.S., well below the 600-plus it visited in each of the prior two years, the Government Accountability Office said last month. FDA has also struggled to keep up with inspections within U.S. borders, conducting just 52 during the same seven-month period last year, compared with roughly 400 each in 2019 and 2018."

Read the full source article: Drug industry pushes FDA to solve growing inspection backlog - Politico

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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!

 

Wednesday, February 3, 2021

FDA names its first medical device cybersecurity director - Fierce Biotech

According to the article:

"The FDA has appointed its first medical device cybersecurity chief to help guide the agency’s regulatory strategies as more devices become interconnected—and potentially more vulnerable to digital attacks and breaches.

Kevin Fu, an associate professor and research fellow at the University of Michigan, was named to the post. He will serve a one-year term as an expert-in-residence at the agency’s Center for Devices and Radiological Health (CDRH) as well as at its nascent Digital Health Center of Excellence, which launched last fall."

Read the full source article:  FDA names its first medical device cybersecurity director - Fierce Biotech

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FDA GMP QSR cGMP Online Training - recommended GMP online training courses offered by SkillsPlus International Inc.
FDA GMP QSR cGMP Online Training - recommended GMP online training courses offered 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!

 

Thursday, January 14, 2021

FDA Veteran Woodcock Being Considered to Lead Agency Under Biden - Bloomberg News

According to the article:

"Janet Woodcock, a 30-year veteran of the Food and Drug Administration, is being considered by President-elect Joe Biden to serve as commissioner of the agency, according to people familiar with the selection process.

Woodcock is expected to serve as acting head of the drug regulator after Biden’s inauguration next week, while being vetted by the Biden team for the permanent job along with former FDA principal deputy commissioner Joshua Sharfstein, according to the people."

Read the full news article:  FDA Veteran Woodcock Being Considered to Lead Agency Under Biden - Bloomberg News

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Tuesday, December 22, 2020

FDA Picks New Target Date For Releasing Its Draft Harmonized Quality System Regulation - Medtech Insight

Updated March 4, 2021

FDA Misses Fifth Target Date For Issuing Draft Harmonized Quality System Reg - Medtech Insight

---  original post follows below  ---

According to the article:

"February 2021 is the latest target date selected by the US agency for releasing a draft of its retooled QSR, which has been undergoing a facelift for more than two years to harmonize it with international quality systems standard ISO 13485.  ...

This is the fifth in-house deadline the FDA has set for issuing its draft rule, which will harmonize the QSR with international quality systems standard ISO 13485:2016. The agency had previously set deadlines of April 2019, September 2019, April 2020 and October 2020."

Read the full article:  FDA Picks New Target Date For Releasing Its Draft Harmonized Quality System Regulation - Medtech Insight

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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!

 

Monday, November 16, 2020

Resuming Normal Drug and Biologics Manufacturing Operations During the COVID-19 Public Health Emergency - FDA Guidance

View the source FDA Guidance:  Resuming Normal Drug and Biologics Manufacturing Operations During the COVID-19 Public Health Emergency - Guidance for Industry (PDF)

According to the guidance:

"FDA is issuing this guidance to help drug and biological product manufacturers during the COVID-19 public health emergency plan and prioritize current good manufacturing practice (CGMP) activities as they transition from operations impacted by the public health emergency to normal manufacturing operations. This guidance describes how to evaluate and prioritize the remediation of CGMP activities that were necessarily delayed, reduced, or otherwise modified during the public health emergency in order to maintain production and the drug supply."

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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!

 

Monday, October 5, 2020

Replacement of Title 21 CFR Part 820 with ISO 13485-2016 - Clarkston Consulting

Read the full article:   Replacement of Title 21 CFR Part 820 with ISO 13485-2016 - Clarkston Consulting

According to the article:

"The FDA originally published a Notice of Proposed Rule Making (NPRN) in May 2018. The abstract from Regulation Identifier Number (RIN) 0910-AH99 states: “FDA intends to harmonize and modernize the Quality System regulation for medical devices. The revisions will update the existing requirements with the specifications of an international consensus standard for medical device manufactures, ISO 13485:2016. The revisions are intended to promote the use of more modern risk management principles and reduce regulatory burdens on device manufacturers and importers by harmonizing domestic and international requirements.” The NPRM is currently at the Proposed Rule Stage with an action date in October 2020. A panel committee meeting will be held after issuance of the proposed rule."

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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!

 

Wednesday, September 23, 2020

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

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

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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!

 

Wednesday, September 16, 2020

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

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

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.

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Wednesday, August 19, 2020

Medical Device Shortages During the COVID-19 Public Health Emergency - FDA.gov

According to the FDA article:

"One provision of this new statutory authority—section 506J(g) of the FD&C Act— requires the FDA to maintain a publicly-available, up-to-date list of the devices the FDA has determined to be in shortage. In addition, the FDA is providing a list of medical devices for which the FDA has been notified that manufacturing has been permanently discontinued. The list below fulfills this statutory obligation and reflects the categories of devices the FDA has determined to be in shortage at this time, and will be maintained and updated as the COVID-19 public health emergency evolves."

Read the full source article, and view the list:  Medical Device Shortages During the COVID-19 Public Health Emergency - FDA.gov

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FDA GMP QSR cGMP 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!

 

Tuesday, July 14, 2020

FDA complicates 'chaotic' federal COVID-19 response with pledge to resume domestic inspections - Fierce Pharma

Read the full source article:

FDA complicates 'chaotic' federal COVID-19 response with pledge to resume domestic inspections - Fierce Pharma


According to the article:

"The FDA will resume "prioritized" domestic manufacturing inspections the week of July 20 after a four-month moratorium on most on-site walkthroughs, FDA Commissioner Stephen Hahn, M.D., said in a release Friday. 
However, a troubling uptick in new COVID-19 cases and deaths means the agency will weigh local virus activity when deciding which sites to inspect, and that fact had analysts questioning the FDA's announcement."

Read the FDA Statement, Coronavirus (COVID-19) Update: FDA prepares for resumption of domestic inspections with new risk assessment system - FDA.gov

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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!

 

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."

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



 

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, December 28, 2019

Retail Sales of Tobacco Products - FDA.gov

Updated August 22, 2026

You might also like: 

Tobacco Products:
https://www.fda.gov/tobacco-products

---  the original post follows below  ---

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

Friday, December 13, 2019

It's official: New FDA Commissioner Hahn wins Senate confirmation - FiercePharma

Read the full article:  It's official: New FDA Commissioner Hahn wins Senate confirmation - FiercePharma

According to the article:

"The FDA has been plenty busy without an official commissioner since former head Scott Gottlieb stepped down earlier this year, but now it has a new chief to take on the job.

Stephen Hahn, formerly chief medical officer of the University of Texas MD Anderson Cancer Center, secured confirmation from the Senate Thursday in a 72-18 vote, according to reports. He takes over the agency's sprawling brief, which covers pharmaceuticals, food safety, medical devices and tobacco."

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!

 

Tuesday, July 23, 2019

FDA warns company marketing unapproved cannabidiol products with unsubstantiated claims - FDA.gov

Read the full news release:  FDA warns company marketing unapproved cannabidiol products with unsubstantiated claims to treat cancer, Alzheimer’s disease, opioid withdrawal, pain and pet anxiety - FDA.gov


Agency is expediting work to evaluate regulatory policies related to cannabis and cannabis-derived ingredients like CBD

According to the news release:
"... the U.S. Food and Drug Administration announced that it has issued a warning letter to Curaleaf Inc., of Wakefield, Massachusetts, for illegally selling unapproved products containing cannabidiol (CBD) online with unsubstantiated claims that the products treat cancer, Alzheimer’s disease, opioid withdrawal, pain and pet anxiety, among other conditions or diseases."  ... 
"The FDA has previously sent warning letters to other companies illegally selling CBD products that claimed to prevent, diagnose, treat, or cure serious diseases, such as cancer. Some of these products were in further violation of the Federal Food, Drug and Cosmetic Act because they were marketed as dietary supplements or because they involved the addition of CBD to food."

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!

 

Friday, July 12, 2019

Report On The State Of Pharmaceutical Quality - FDA.gov


Center For Drug Evaluation And Research - Office Of Pharmaceutical Quality

Report On The State Of Pharmaceutical Quality - FDA.gov

Assuring quality medicines are available for the American public


The report is a good read.  It's data-rich, and provides a good overview.

This comes from the report's introduction:

"The Office of Pharmaceutical Quality (OPQ) in the Center for Drug Evaluation and Research (CDER) in the U.S. Food and Drug Administration (FDA) monitors the quality of CDER-regulated drugs legally marketed in the U.S. A quality drug is consistently safe and effective, free of contamination and defects. Patients and consumers expect quality drugs with every dose they take. The ‘State of Pharmaceutical Quality’ is a yearly snapshot of the pharmaceutical manufacturing industry’s ability to deliver quality pharmaceutical products."

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Thursday, July 11, 2019

What You Need to Know (And What We’re Working to Find Out) About Products Containing Cannabis or Cannabis-derived Compounds, Including CBD - FDA.gov

Read the FDA article: What You Need to Know (And What We’re Working to Find Out) About Products Containing Cannabis or Cannabis-derived Compounds, Including CBD - FDA.gov


According to the FDA article:

"The FDA is committed to sound, science-based policy. The FDA is raising these safety, marketing and labeling concerns with you now because we want you to know what we know. We hope that you will provide any data that you have to the public docket.
Today’s Consumer Update includes a practical summary of what we know to date. As we learn more, our goal is to update you with the information you need to make smart choices about CBD products. Also, as the regulatory pathways are clarified we will take care to notify all stakeholders as quickly as possible.