Tuesday, December 31, 2013

Make A New Year Resolution - Take A GMP Trainer Certification Course

SkillsPlus Intl Inc.'s next public seminar of the highly popular GMP Trainer Certification Course is May 5-9, 2014 in Fort Lauderdale, FL.  Learn more: http://www.skillsplusinc.com/Pub_Sem.htm

This is a life-changing five-day class in which participants experience many different ways to teach CGMPs and QSRs. Learn what your instructor is thinking about during sessions, so that you can repeat that training approach in your organization.

Students make 2 presentations demonstrating their skills during the class. This class is suitable for food and dietary supplement manufacturers also.
  1. Upon course completion, participants will be able to:
  2. Explain the essentials of the CGMP/QSR regulations. 
  3. Use the philosophical basis for the rules and interpretation to respond to CGMP/QSR related questions. 
  4. Demonstrate techniques to present CGMP/QSR content in memorable ways.
  5. Design and conduct activities that reinforcement learning. 
  6. Facilitate discussions and questions like a pro. 
  7. Respond to difficult questions.
  8. Deal successfully with difficult students. 
  9. Manage class room media. 
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Wednesday, December 25, 2013

Merry Christmas!


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Monday, December 23, 2013

Designated Representative Training & 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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Wednesday, December 4, 2013

2014 cGMP Procedure (SOP) 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! 

    • Does your company constantly update and revise procedures, or
    • Are procedures the root cause of many deviations, or
    • 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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    Tuesday, December 3, 2013

    FDA Prepares Compounding Blacklist of Banned Products - RAPS RF

    FDA Prepares Compounding Blacklist of Banned Products - RAPS RF:

    "In a Federal Register announcement on 2 December 2013 — just days after the DQSA was signed into law — FDA said it wanted public input on which drugs should comprise such a list.

    "To identify candidates for the difficult-to-compound list, FDA is seeking public input in the form of specific drug products or categories of drug products that are difficult to compound," the agency wrote."

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    FDA aims to oversee drug compounders - USA Today

    FDA aims to oversee drug compounders - USA Today:

    ""We will be encouraging health care providers and health networks to consider strongly purchasing compounded products from FDA-registered and regulated facilities," FDA Commissioner Margaret Hamburg says. "This will be a critical step they can take to better assure the health and safety of their patients."

    Outsourcing facilities will also be required to report specific information about the products they compound, including a list of all the products compounded during the previous six months, and details about the source of the active ingredient, as well a report known as adverse effects."

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    Monday, December 2, 2013

    The Best GMP Trainers are . . .

    If you're a trainer, here's some food for thought.

    Rob Packard of the Medical Device Academy was quoted on LinkedIn, "that there are four prerequisites for a great Instructor:
    1. The instructor must be an expert.
    2. The instructor must inspire participation.
    3. The instructor must provide practical examples for each student.
    4. The instructor must get everyone’s attention – and keep it."
    If Rob's wise words resonate with you, then consider joining us for our highly recommended, and extremely popular GMP Trainer Certification Public Seminar (click to learn more). 

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