Exploring better options for ACL repairs – MassDevice

Updated September 22, 2016

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NEW ACL SURGERY COULD CUT REHAB AND RECOVERY TIME IN HALF - An engineer-turned-doctor says clinical studies show real promise

- -  original post follows below  - -

Read more, and watch the animation: Exploring better options for ACL repairs – MassDevice:

"An anterior cruciate ligament (ACL) tear can be a devastating sports injury. Every year, 400,000 people, many of them teen and young adult athletes, sustain ACL injuries or tears. Martha Murray, MD, an orthopedic surgeon at Boston Children’s Hospital, worked with a team of colleagues to create a new procedure known as bridge-enhanced ACL repair (BEAR) that encourages natural healing."

'via Blog this'

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SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
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Do You Have SOP Compliance Problems?

#FDA #GMP #cGMP #QSR #training #course

• Do CGMP documents contain many errors, or
• Are change controls often side-stepped, or 
• Is the Quality Unit often side-stepped, or 
• Are procedures not always followed?

If you answered "Yes" to any of these questions, then take a look at our Qualstar: A CGMP Training Simulation course.

Featured Course:   Qualstar - A CGMP Simulation
Designed to teach and to change the culture of companies in order to focus on quality and compliance. 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!
Examine The Qualstar Outline

Ready? Set? Go! and feel the high energy of this popular and exciting course.

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. Request a quotation by email

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The Exemptee Institute
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Related articles

• 2014 GMP Training Recommended: The Qualstar Simulation (drughealth.blogspot.com)
• Once Again, Lack of SOP Compliance Tops List of 483 Observations - BioProcess Blog (drughealth.blogspot.com)

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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Video Clip For FDA GMP Documentation Training From SkillsPlus

Checkout this free video clip preview from SkillsPlus International Inc.

It's a preview for online e-Learning CBT (computer-based training) on proper documentation procedures. What's cool is, there's just enough useful material in the 'long' version of the preview that you can use it as a part of your training program:  The 'long' version preview of Overcoming the Documentation Nightmare by SkillsPlus International Inc.

Here's the 'short' version of the preview:



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Computer-Based Training by SkillsPlus International Inc.

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FDA Warning - Lipodissolve Products

The FDA has sent sent warning letters to six medical spas in the United States - and a cyber letter to a company in Brazil - for making false or misleading statements on their Web sites about drugs used in the procedure, or for otherwise misbranding lipodissolve products.

 Janet Woodcock, M.D., Director of FDA’s Center for Drug Evaluation and Research (CDER) says:

"We are concerned that these companies are misleading consumers. It is important for anyone who is considering this voluntary procedure to understand that the products used to perform lipodissolve procedures are not approved by FDA for fat removal."

The FDA website provides more information on the topic, FDA Warns About Lipodissolve Product Claims, with a downloadable pdf. 

I'm not a big fan of liposuction, let alone this approach using lipo-dissolving chemicals.

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FDA Holiday Food Safety

The holidays are about spending time with friends and family. Naturally, food will be served and shared. So beware! Take a few moments to review best food handling practices to keep everybody happy and food healthy! Follow these FDA food safety recommendations, Food Safety Tips for Healthy Holidays, or download this newsletter, Food Safety Tips for Healthy Holidays (pdf). 

Bottomline...

1. Clean
2. Separate
3. Cook
4. Chill

Previous Posts: Happy Thanksgiving - Celebrate These Food Safety Tips 

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Procedure For FDA GMP Training

Don't forget the basics! Read this classic Jim Vesper article, Defining Your GMP Training Program with a Training Procedure. Make sure you've got some well-thought out standard operating procedures that define your FDA GMP training program. 

Previous Posts: GMP Training Tree - Trainers, formats, methods, etc. Try This GMP Training Tip To Start The New Year (free) WHO Basic GMP Training Modules (free) FDA CDRH Online Courses (Free) Free WHO Training Guide To GMP Requirements Free GMP Training Tips - Follow adult learning principles Free GMP Glossary GMP Olympics - an onsite training experience 

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