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."

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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"

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CA Designated Representative & Exemptee Training Course - Enhanced for iPad

English: Apple iPad Event
English: Apple iPad Event (Photo credit: Wikipedia)
NEW - Now viewable on an iPad!

Our highly popular California Designated Representative and Exemptee training certification course has been refreshed, and updated to support viewing & course completion on an iPad.
  • Enhanced for iPad
  • iPad ready
  • Optimized for iPad
  • iPad viewable

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Training for Designated Representative & Exemptee license applicants

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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."

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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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