Merry Christmas!

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Report: Christmas will kill you | National Monitor

Christmas in the post-War United States (Photo credit: Wikipedia)

Report: Christmas will kill you | National Monitor:

"According to a Medical Daily report, the most common causes of death during Christmas and extending to the New Year are cardiac disease, respiratory diseases, endocrine/nutritional/metabolic problems, digestive diseases, and cancer."

'via Blog this'

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We Moved Forward on Many Fronts This Year | FDA Voice

Commisioner of the United States Food and Drug Administration Margaret Hamburg. (Photo credit: Wikipedia)

We Moved Forward on Many Fronts This Year | FDA Voice:

"All of us take great pride in the skill and vigor with which we overcame the year’s challenges and new demands. And so, as the year draws to a close, I extend my gratitude to the employees at the FDA who work tirelessly on behalf of the American public year in and year out. To all of our stakeholders, my heartfelt wishes for a joyous holiday season and a safe and healthy 2014.

Margaret A. Hamburg, M.D., is the Commissioner of the Food and Drug Administration"

'via Blog this'

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Expert Panel Want BP Cuffs Loosened - MedPage Today

Updated July 5, 2024

The original link broke.

You might also like:

How Do BP Cuffs Affect Blood Pressure Monitoring - Unimed

---  the original post follows below  ---

Expert Panel Want BP Cuffs Loosened: - MedPage Today:

"For most hypertensive individuals 60 or older, pharmacologic treatment should be started when the systolic pressure is 150 mm Hg or higher or the diastolic pressure is 90 mm Hg or higher, with the goal of achieving readings below those cutoffs, according to the new recommendations."

'via Blog this'

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FDA Drug Quality and Security Act Stakeholder Discussion Notes - No Bullwhip

• Recommended FDA cGMP online training courses, programs, and classes offered by SkillsPlus International Inc.

Updated October 24, 2022

The original link broke.

You can still read about the same topic here:

Drug Quality and Security Act - What You Need to Know - McGuireWoods.com

---  the original post follows below  ---

FDA Drug Quality and Security Act Stakeholder Discussion Notes - No Bullwhip:

"The FDA held its first public stakeholder call this morning (Dec. 3rd, 2013) to discuss the new Drug Quality and Security Act law. This is the first of a series of public engagements that the FDA will hold as the various provisions of DQSA are phased in starting Jan. 1, 2015 and continuing over the next 10 years.

The call, led by Dr. Ilisa Bernstein and Cara Tenenbaum of the FDA, didn't contain much in the way of hard specifics on rules, regulations and licensure. The FDA is still developing its go-forward plans and communication processes."

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Procedure Writing Course

483 Observation Gotchas!

1. Firm's procedures lack sufficient detail.

2. Employees perform significant steps not included in procedures.

3. Firm lacks procedures for a variety of production, maintenance, and quality assurance activities.

Plan Your Training!

1. Does your company constantly update and revise procedures, or
2. Are procedures the root cause of many deviations, or
3. Are procedures ignored, being replaced by word-of-mouth guidance from colleagues?
   
   If you answered "Yes" to one or more of these questions, then you need to take a look at our Writing Standard Operating Procedures workshop.

Learn More About the SkillsPlus Writing SOPs Workshop
 

Featured Course

Writing Procedures: This course is as much about consulting as training. In this course, Allan reviews and consults on a firm's procedure for writing procedures, and then coaches employees on procedure writing. Employees work with existing or needed procedures in this workshop.

Tools addressed in this very popular workshop:
1. Readability analysis

2. Task analysis

3. Decision-making through procedures

4. Determining the appropriate level of detail

5. Task grouping for greater comprehension

6. Procedure reviews and more!

If your firm is not satisfied with the quality of procedures, then you need to look into our Writing Procedures workshop!

Examine The Procedure Writing Course Outline
  

Allan Dewes, President.

About Your Instructor

Allan Dewes

Allan Dewes has worked on writing procedures and training others to write procedures for over 30 years. Allan understands CGMP regulations, the FDA expectations, and how to make procedures easy to write and understand.

Call Today!

SkillsPlus International Inc.
(415) 948-5220

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Nanotech Roundup: Latest National Nanotechnology Initiative Strategic Plan Released for Comment - FDA Law Blog

FDA Law Blog: Nanotech Roundup: Latest National Nanotechnology Initiative Strategic Plan Released for Comment; NYAS Nanomedicine Conference Summary:

"The draft plan lays out the NNI’s goals and objectives, which remain largely unchanged from 2011 (see here). As with the 2011 Plan, the draft 2014 Plan includes a description of FDA’s NNI-related activities. Those activities continue to be primarily focused on the goal of supporting responsible development of nanotechnology. However, the 2014 Plan more explicitly recognizes the potential impact of nanotechnology on the status of FDA-regulated products:" . . .

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Buy, Store & Serve Safe Food - The FDA on Holiday Food Safety

• People are also interested in FDA GMP Online Training - recommended FDA CGMP online training classes by SkillsPlus International Inc. (a trusted compliance training vendor)

Buy, Store & Serve Safe Food > Holiday Food Safety - FDA.gov:

"Many people don't realize that food safety is the most important ingredient in preparing food for the holidays. Below are some helpful food safety resources to keep your holidays happy.

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Overhaul of CDRH's Office of Compliance Creates Six-Division Structure, New Advertising Office

• Recommended FDA CGMP online training courses taught by SkillsPlus International Inc.

Follow the link below to see who's going to be in charge . . .

Overhaul of CDRH's Office of Compliance Creates Six-Division Structure, New Advertising Office - RAPS:

"The Center for Devices and Radiological Health (CDRH), the US Food and Drug Administration's (FDA) medical device regulation and compliance-enforcement body, has announced that it has reorganized its Office of Compliance (OC) with the stated goal of better aligning its resources to its mission."

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Taking Aspirin at Night May Boost Heart Benefits - NYTimes.com

Taking Aspirin at Night May Boost Heart Benefits - NYTimes.com:

"Ultimately the researchers found that morning platelet activity was reduced to a much greater degree when the aspirin was taken at night. The timing of the aspirin, however, had no impact on morning blood pressure levels, which was something else the researchers measured."

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AHA, ACC Stand Firm in Support of Cardiovascular Risk Calculator

AHA, ACC Stand Firm in Support of Risk Calculator - MedPage Today:

"The dust-up over the new cardiovascular disease prevention guidelines -- already named "Calculator-gate" -- prompted the American Heart Association and American College of Cardiology to stage a public defense at a hastily assembled press briefing here.

Although there are four guidelines in the new prevention package it is the assessment of risk -- the so-called risk calculator -- and the recommendation that statins be used as primary prevention that have drawn fire."

View the AHA, ACC public response (video)

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10 Tips to Avoid Holiday Weight Gain - HealthCastle

Updated November 14, 2021

The original link broke.

You can still read about the same topic here:

20 Tips to Avoid Weight Gain During the Holidays - Healthline

---  the original link follows below  ---

Follow the link below to view the 10 tips . . .

10 Tips to Avoid Holiday Weight Gain - HealthCastle:

"The holiday and party season is upon us! Studies show that the weight gain around this time of year is more than just an urban legend. It adds up to a solid 1-2 pounds per year for most adults, more for adults who are already overweight. This year, skip the weight gain altogether and stay one step closer to your best self with these easy strategies."

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2013 Food Code is Out - Time for Light Reading | Marler Blog

2013 Food Code is Out - Time for Light Reading | Marler Blog:

"This Summary provides a synopsis of the textual changes from the 2009 FDA Food Code and the Supplement to the 2009 Food Code Chapters and Annexes to the 2013 edition. The primary intent of this record is to capture the nature of the changes rather than to identify every word or editing change. This record should not be relied upon as an absolute comparison that identifies each and every change."

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You Can Help Cut Acrylamide in Your Diet - FDA

Consumer Updates > You Can Help Cut Acrylamide in Your Diet:

"Cutting down on certain fried foods can also help you cut down on the amount of acrylamide you eat. That's a good thing because high levels of acrylamide have been found to cause cancer in animals, and on that basis scientists believe it is likely to cause cancer in humans as well."

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GMP Training Suggestions for 2014 - cGMP Essentials Course

 

483 Observation Gotchas!   1. There is no documented training in CGMPs. 2. CGMP training has not been conducted for over three years. 3. Firm lacks qualified CGMP trainers.      Planning for Training 2014!  2014 is just around the corner!  Do you need to get CGMP and related training completed and do not have the staff, or Are you and your staff already overloaded, or Do you just need a new and exciting approach to CGMP training? If you answered "Yes" to one or more of these questions, then take a look at our CGMP Essentials course. Learn More About the SkillsPlus CGMP Essentials course   Featured Course CGMP Essentials: This course can be structured with more than two dozen different training activities designed to reinforce learning and keep employees engaged. Prior students have high praise. One manager said, "I never knew CGMP training could be so much fun." One former FDA Inspector reported, "I actually learned something."   Topics addressed in this very popular course: 1. Heard on the Street 2. Review of 21 CFR 211 Subparts 3. Essential Quality System Tools 4. Consequences for non-compliance, and more!   If your firm needs a fresh new look at CGMP training, then you need to look into our CGMP Essentials course!   Examine The CGMP Essentials Course Outline   Allan Dewes, President.   About Your Instructor Allan Dewes   Allan Dewes has been training employees for over 40 years, with 30 years in the pharmaceutical industry. Allan understands CGMP regulations, the FDA expectations, and how to make training fun to maximize retention.   Email today to request a quotation

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GMP Training Ideas - Executive Session

• You might also be interested in FDA CGMP online training courses and programs taught by SkillsPlus International Inc.

Updated August 10, 2024

The "Executive Session" course is no longer available.

Additional online class offerings can be viewed, by following the link above.

---  the original post follows below  ---

483 Observation Gotchas!   1. Firm lacked an effective training program to ensure all employees, including upper management, are fully trained on CGMPs. 2. Management failed to prevent non-controlled documents from being in the dispensing area. 3. Management did not understand their role & responsibility in supporting & enforcing the quality system.            Planning for Training 2014!  2014 is just around the corner!  Can't get management staff to attend your CGMP training sessions, or Not quite sure what to present to management staff for annual CGMP training, or Does management feel that they do not need to attend annual CGMP training? If you answered "Yes" to one or more of these questions, then you need to take a look at our Executive Session 2014 CGMP Update.    Featured Course Executive Session 2014 CGMP Update: This course focuses on what the executive needs to know. There's no discussion of "single-line through ... yada, yada, yada," in this course.   Topics addressed in this intense update: 1. Annual observation update 2. What the observations mean to executives and managers 3. Consequences 4. Interesting court cases 5. Current trends and more!   If your firm needs to get some of your executives and managers into meaningful CGMP training, then you need to look into our Executive Session 2014 CGMP Update!   Return Home: The Health, Drug, Prescription, and GMP Supersite Blog SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors SkillsPlus Intl Info Blog The Exemptee Institute The Designated Representative Institute The Health, Drug, Prescription, and GMP Supersite Gift Store

FDA Targets Trans Fat in Processed Foods

Consumer Updates - FDA Targets Trans Fat in Processed Foods:

"Part of the FDA's responsibility to the public is to ensure that food in the American food supply is safe. Therefore, due to the risks associated with consuming PHOs, FDA has issued a Federal Register notice with its preliminary determination that PHOs are no longer "generally recognized as safe," or GRAS, for short."

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2014 GMP Training Ideas - Deviation Investigation Report Writing Workshop

483 Observation Gotchas!

1. Deviation reports failed to include a discussion of product impact.

2. Investigation reports stated this was an isolated incident, yet the database revealed 13 similar incidents.

3. Investigation reports failed to provide data to support the root cause determination

Planning for Training 2014!  2014 is just around the corner!  Do your investigation reports wander all over and never get to the point, or Do deviation reports fail to document a sound root cause conclusion, or Do deviation report writers never seem to know what Quality Assurance wants discussed in the report? If you answered "Yes" to one or more of these questions, then take a look at our Investigations Report Writing clinic. Learn More About the SkillsPlus Investigation Report Writing Clinic

Featured Course Deviation Investigation Report Writing Clinic: This course is hands-on and personal. In this clinic, students: learn about each section of your company's investigation report; write each section of the report for a real investigation report, and then; receive personal coaching privately from Allan. This course is not the typical spelling and grammar checking training program often offered. Common sections addressed in this very popular workshop: 1. Deviation Description 2. Previous Related Investigations 3. Product Impact Assessment 4. Root Cause Investigation Discussion 5. Root Cause Determination 6. Risk Assessment 7. Corrective and Preventive Actions and more! If your firm is not satisfied with the quality of deviation investigation reports, then you need to look into our Deviation Investigation Report Writing Clinic! Examine The SkillsPlus Investigation Report Writing Clinic Outline

Allan Dewes, President. About Your Instructor Allan Dewes Allan Dewes has been teaching others to write deviation investigation reports for over 15 years. Allan understands CGMP regulations, the FDA expectations for deviation investigation reports, and how to coach others to write a quality document. Email today to request a quotation

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If you are looking for live, onsite, in-person delivered courses or classes, then consider the following popular courses:

Our most popular course

Put fun back into GMP training!

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FDA: Janssen Pharma - Pleads Guilty - To Pay Over $1.6 billion - re: Risperdal

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

Updated August 29, 2020

The link in the original post broke.

You might also be interested in the DOJ's statement about the issue:

Johnson & Johnson to Pay More Than $2.2 Billion to Resolve Criminal and Civil Investigations
Allegations Include Off-label Marketing and Kickbacks to Doctors and Pharmacists - Justice.gov

- - -  the original post follows below  - - -

Press Announcements > FDA: Janssen Pharmaceuticals, Inc. to plead guilty and pay over $1.6 billion to resolve allegations of misbranding and filing false claims for its schizophrenia drug Risperdal:

"U.S. Department of Justice today announced a guilty plea agreement with Janssen Pharmaceuticals, Inc., (JPI) of Titusville, N.J., and a $400 million criminal fine for introducing a misbranded drug, Risperdal (risperidone), into interstate commerce. A Johnson & Johnson Company, JPI must also pay $1.25 billion under a separate civil settlement concerning the same drug. The combined criminal plea and civil settlement agreement related to Risperdal totals more than $1.67 billion."

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GMP Training - Online Training Courses

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

Updated October 10, 2020

Links broke in the original post.

You might also be interested in:

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

- - -  original post follows below  - - -

 

Plan for cGMP Training 2014!

 2014 is just around the corner! 

1. Do your employees avoid CGMP training, claiming they've heard it all, or
2. Do they resist attending CGMP training because "their" job is never discussed, or
3. Do some employees "drift off" in CGMP training because it is too theoretical?
   
   If you answered "Yes" to one or more of these questions, then you need to take a look at our GMP Olympics Refresher course.

Learn More About SkillsPlus
 

 

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Herbal Supplements Are Often Not What They Seem - NYTimes.com

Herbal Supplements Are Often Not What They Seem - NYTimes.com:

"DNA tests show that many pills labeled as healing herbs are little more than powdered rice and weeds."

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2014 GMP Training Ideas - Root Cause Analysis of Deviations Workshop

2014 GMP Training

Root Cause Analysis of Deviations:

This course is more than idle chat. In this workshop, students apply root cause analysis tools to real in-plant deviations.

Tools addressed in this very popular workshop:
1. 5-Whys In-Depth Map
2. Sequence of Events
3. Distinctions
4. Walk-Through Analysis
5. Change Analysis
6. Control Barrier Analysis
7. Fishbone Diagrams and more!

If your firm is not satisfied with the quality of deviation investigations, then you need to look into our Root Cause Analysis of Deviations workshop!

Follow this link to learn more about our Root Cause Analysis of Deviation Workshop (a GMP training course)

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Thinking of quitting smoking? Mondays may be your day : USA Today

Thinking of quitting smoking? Mondays may be your day - USA Today:

"There's no such thing as a bad day to stop smoking, but a new study shows Monday is a particularly popular day to think about it – or at least Google it.

Google searches for terms such as "quit smoking help" make up a higher proportion of all searches on Mondays than on any other day . . . "

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2014 GMP Training Recommended: The Qualstar Simulation

Qualstar - A CGMP Simulation:

Designed to teach and to change the culture of companies, so that a focus on quality and compliance is achieved. This competitive simulation is an eye-opener for participant and executive staff observers alike.

Issues addressed in this exciting simulation:
1. Documentation problems
2. Procedures not being followed
3. Change control not practiced
4. QA not consulted on deviations

If this describes some of your issues, then you need to experience Qualstar!

Follow this link to learn more about Qualstar - A cGMP Simulation (a GMP training course)

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FDA > Decorative Contact Lenses: Is Your Vision Worth It?

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

Updated August 11, 2023

The original link broke.

You might also be interested in:

Colored and Decorative Contact Lenses: A Prescription Is A Must - FDA.gov

---  the original post follows below  ---

Consumer Updates > Decorative Contact Lenses: Is Your Vision Worth It?:

"But before buying decorative lenses, here’s what you should know:

They are not cosmetics or over-the-counter merchandise. They are medical devices regulated by the Food and Drug Administration (FDA). Places that advertise them as cosmetics or sell them without a prescription are breaking the law."

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As nanotechnology is being used to develop new drugs, FDA is working to ensure quality, safety, and effectiveness | FDA Voice

As nanotechnology is being used to develop new drugs, FDA is working to ensure quality, safety, and effectiveness | FDA Voice:

"Materials at the nanoscale can have different chemical, physical, or biological properties compared to their conventionally-scaled counterparts. Scientists can use these features to enhance the properties or the quality of a drug. But because such properties can affect the quality, safety, or effectiveness of a drug, FDA is studying these issues related the use of this powerful new technology in medical products."

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Does The Government Shutdown Impact FDA Inspections?

How Does the Government Shutdown Impact FDA Inspections? | FDAzilla Blog:

"Nonetheless, in no way does this mean to let down your guard.

When we get in the inspections data, we’ll have a clearer picture of what’s really going on. As you can see, the FDA is definitely already on pace for a slower year in terms of inspections and 483s."

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FDA Running At Reduced Capacity - Government Shutdown

Government Shutdown Leaves FDA Operating at Reduced Capacity, But User Fees Act as Agency Savior:

" . . . Steven Immergut, another FDA spokesman, who elaborated on the practical effects of the shutdown.

The facts and figures are stark: 45% of the agency's staff is not permitted to work until funding is provided. Nearly 75% of FDA staff remaining on the job are funded through industry-paid user fees, otherwise they would likely be furloughed as well. It was not immediately clear if they would receive pay at the usual intervals."

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Mobile Medical Applications: Guidance Finalized - FDA Law Blog

• Respected FDA GMP online training programs and courses by SkillsPlus International Inc.

FDA Law Blog: Mobile Medical Applications: A Thoughtful Guidance Is Finalized:

"The final guidance is similar to the draft guidance – but with improved clarity. Hence, it has expanded from 29 to 43 pages. Most of the additional pages are appendices with examples and other supplementary information. This guidance is sensible and well written."

Follow this link to the Mobile Medical Applications - FDA Guidance for Industry and Food and Drug Administration Staff (PDF)

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