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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• 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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Medical Devices Infected By The Conficker PC Worm

Be very afraid. Hospital and medical devices have been found to be infected by a computer worm (kind of like a virus), reports this Mercury News article, Conficker worm hits hospital devices, "A computer worm that has alarmed security experts around the world has crawled into hundreds of medical devices at dozens of hospitals in the United States and other countries, according to technologists monitoring the threat." What I find so disturbing in the article is, "the working group has seen thousands of other machines located in hospitals reach out to the Conficker mastermind by contacting another computer on the Internet for instructions." The potential danger could be leaking of your health information, or the medical devices could be recruited as robots in an attack on other computer systems. Isn't technology grand!? 

Related Posts: Read Or Download The GAO Report - The FDA And High Risk Medical Devices (pdf) 2009 - Top 10 Trends For The Medical Equipment Market 

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