Wednesday, December 25, 2013

Merry Christmas!


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Tuesday, December 24, 2013

Report: Christmas will kill you | National Monitor

Christmas in the post-War United States
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...
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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Thursday, December 19, 2013

Expert Panel Want BP Cuffs Loosened - MedPage Today

Aneroid sphygmomanometer with stethoscope, use...
Aneroid sphygmomanometer with stethoscope, used for auscultatory blood pressure measurement. (Photo credit: Wikipedia)
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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Thursday, December 5, 2013

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

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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Tuesday, December 3, 2013

2014 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.
 
 

 

Planning for Training 2014!

 2014 is just around the corner! 
  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.




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!
 

Allan Dewes
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) 487-3500  |  (954) 873-7422
San Francisco  |  Fort Lauderdale

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Monday, December 2, 2013

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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Sunday, November 24, 2013

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

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.

On this page:
Holiday Food Safety Success Kit
Holiday Food Safety Video
Ready-to-Cook Foods
Additional Information"

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Wednesday, November 20, 2013

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

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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Tuesday, November 19, 2013

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

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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Sunday, November 17, 2013

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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Friday, November 15, 2013

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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Wednesday, November 13, 2013

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! 
  1. Do you need to get CGMP and related training completed and do not have the staff, or
  2. Are you and your staff already overloaded, or
  3. 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.
 

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!
 

 
Allan Dewes
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.
 
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Monday, November 11, 2013

2014 GMP Training Ideas - Executive Session (2014 cGMP Updates)

 
 
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! 
  1. Can't get management staff to attend your CGMP training sessions, or
  2. Not quite sure what to present to management staff for annual CGMP training, or
  3. 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!
 

Allan Dewes
Allan Dewes, President.
 
About Your Instructor
Allan Dewes

Allan Dewes has been training CGMP for over 30 years, including managers and executives. Allan knows how to adjust his comments and focus on the needs of executives and managers.

 
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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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Thursday, November 7, 2013

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! 
  1. Do your investigation reports wander all over and never get to the point, or
  2. Do deviation reports fail to document a sound root cause conclusion, or
  3. 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.



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!


Allan Dewes
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.

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If you are looking for live, onsite, in-person delivered courses or classes, then consider the following popular courses:
Root Cause Analysis & Deviation Investigation Report Writing - cGMP Training
Our most popular course
Qualstar - Pharmaceutical Simulation - Advanced cGMP Training
Put fun back into GMP training!














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Tuesday, November 5, 2013

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

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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Monday, November 4, 2013

GMP Training 2014 - Look at this GMP Olympics Refresher Course

 
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.
 

 
Featured Course
GMP Olympics 2014: Become a participant in the Olympics! This course challenges even the most seasoned employee's knowledge of CGMPs. This course is definitely not for new employees who are new to the industry.
 
Activities from this highly interactive workshop:
1. Heard on the Street
2. Team-based regulation review
3. GMP Challenge
4. Inspection Detection, and more!
 
This course can be customized to meet a variety of content and time constraints.
 
 
 
Allan Dewes
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.

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