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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    Thursday, November 14, 2013

    2014 GMP Training - The 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

    Recommendations for 2014 GMP Training - Executive Session: What Leadership Needs to Know

     
    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.
    Learn More About the SkillsPlus Executive Session 2014 CGMP Update Course
      


     
    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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    Thursday, November 7, 2013

    Dietary Supplement Firms Still Violating Basic Manufacturing Rules - NPI

    Dietary Supplement Firms Still Violating Basic Manufacturing Rules - Natural Products Insider:

    "FDA has been bringing down the hammer on one out of three dietary supplement firms for failing to comply with cGMPs. Through the first several months of fiscal year 2013, of the 350 cGMP inspections FDA originally designated and concluded as falling under Part 111, the agency's 19 district offices collectively classified 33 percent, or 117 businesses, as OAI (official action indicated)."

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    Ideas For 2014 GMP Training - Deviation Investigation Report Writing Clinic

    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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    Tuesday, November 5, 2013

    FDA Proposal - Head Off More Drug Shortages

    FDA proposal aims to head off more drug shortages:

    "The Food and Drug Administration announced a new proposal Thursday to try and head off more shortages of crucial medications that have disrupted care at hospitals and clinics nationwide.

    Under the proposed rule, companies that make medically important prescription medicines would have to notify the FDA six months ahead of any changes that could disrupt the U.S. supply. That includes plans to discontinue a product or manufacturing changes that could slow production."

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    Thursday, October 31, 2013

    2014 GMP Training Ideas - 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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    Monday, October 28, 2013

    2014 GMP Training Recommendation - Root Cause for Deviation Investigations Workshop

    Do your firm's  
    Planning for Training 2014!

     2014 is just around the corner! 
    1. Do your firm's investigations conclude no assignable root cause, or
    2. Do your firm's investigations conclude the root cause was human error, or
    3. Do your investigations fail to identify product impact?

      If you answered "Yes" to one or more of these questions, then take a look at our Root Cause for Deviation Investigations workshop.
     

    Featured Course
    Root Cause Analysis of Deviations: This course is more than idle chat. In this workshop, students apply root cause analysis tools to real in-plant deviations.
     
    Tools addressed in this very popular workshop:
    1. 5-Whys In-depth Map
    2. Sequence of Events
    3. Distinctions
    4. Walk Through Analysis
    5. Change Analysis
    6. Control Barrier Analysis
    7. Fishbone Diagrams and more!
     
    If your firm is not satisfied with the quality of deviation investigations, then you need to look into our Root Cause Analysis of Deviations workshop!
     
     
    Allan Dewes
    Allan Dewes, President.
     
    About Your Instructor
    Allan Dewes

    Allan Dewes has worked on deviation investigations and trained others to do the same for over 30 years. Allan understands CGMP regulations, the FDA expectations, and how to make deviation training effective and fun.
     
     
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