SkillsPlus International Inc.

 

The Leader in Compliance Training: CGMP, QSR and State Licenses

 

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Drug and  Device - Onsite Courses

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Coaching

Explore onsite courses that the SkillsPlus team can teach at your site. We always tailor our courses to suit your site's learning needs and environment. We also offer individual and small group coaching on specific quality system requirements. 
Course catalog and eBrochure - FDA cGMP QSR GMP Training - Classes, courses, workshops, and seminars

California Designated Representative Certification

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- Drug wholesalers doing business in California or shipping drug products into California need this certification. State Approved. iPad ready! $525 per student.
California Designated Representative-3PL Certification  NEW!

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- 3PL providers offering services for dangerous drugs & devices in CA, or into CA, need this certification. $525 per student.
California Exemptee Certification

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- Home Medical Device Retailers (HMDR) or Durable Medical Equipment (DME) wholesalers doing business in California need this certification. State Approved. iPad ready! $525 per student.
Florida Designated Representative Certification

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Drug wholesalers doing business in Florida or shipping drug products into Florida need this exam preparation course. $525 per student.

Requests and questions? Give us a call :  415.948.5220 | skillsplus@aol.com   |   Fax: 954.566.5225

If you're having trouble sending an email to allan.dewes@skillsplusinc.com, try sending it to skillsplus@aol.com  

 

 

 

 

 
Our Most Popular Live QSR & GMP Training Courses
CGMP Essentials QSR Essentials CGMP Olympics QSR Olympics Conducting Root Cause Analysis Writing Deviation Investigations Writing Procedures

 
Onsite QSR & cGMP Course Descriptions
Auditing: Internal and External Customers and Suppliers Essentials for Pharmaceuticals Qualstar Medical Device Simulation (QSR)
Faster Product Release Through Efficient Batch Record Review Executive Session: What Leadership Needs to Know Qualstar Pharmaceutical Simulation (CGMP)
Creating CGMP Responsibility and Accountability Human Errors: Overcoming the Challenges Risk Assessment: CGMP/QSR for the 21St Century
Creating QSR Responsibility and Accountability ISO: 17025 Calibration Labs Surviving an FDA Inspection
Critical Thinking in a Regulatory Environment Management Sessions: What Every Manager Needs to Know Technical Trainer Certification: A Technical Trainer Readiness Course
Deviation Investigations: Root Cause Analysis Meetings for Swift and Aggressive FDA  Enforcement Trainer Certification: A CGMP QSR Trainer Readiness Course
Deviation Investigations Report Writing Olympics CGMP: Advanced Course Trainer Certification: A QSR Trainer Readiness Course
Essentials for Dietary Supplements Olympics QSR: Advanced Course CGMP: Grab and Gab Series
Essentials for Foods Procedure Writing for Greater Process Controls QSR: Grab and Gab Series
Essentials for Medical Devices Don't see a class. Call us and ask!

 
Coaching: Call to learn more 415.948.5220
Root Cause Analysis Team Coaching Deviation Report 1:1 Coaching Procedure Writing Coaching

 

California Designated Representative Certification Course - New - iPad ready!
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California Exemptee Certification Course - New - iPad ready!
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Florida Designated Representative Exam Preparation Course
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Alphabetical Listing of Topics

Site Map

 

     SkillsPlus International Inc. has been a leader in on-site compliance training for over 22 years. The training staff at SkillsPlus possess expertise in training Good Manufacturing Practice Regulations (cGMP) and Quality System Regulations (QSR). Additionally, the team possesses experience in teaching root cause analysis for investigations, writing deviation investigations, writing procedures, and a wide variety of other cGMP and QSR related topics including executive level compliance training and management skills training. SkillsPlus is the leader in focused training resources including computer-based training movies, interactive CBT training modules, and plug-ins for Learning Management Systems (LMS). Our plug-ins are AICC and SCORM compliant. SkillsPlus also provides learning resources such as cGMP Challenge Lite and Inspection Detection Lite. All designed to create competitive, playful and effective educational environments. SkillsPlus also provides consulting in cGMP compliance, QSR compliance, and Quality Systems including, deviations, investigations, investigation reports, procedure systems development, writing procedures and training system consulting.

     Allan Dewes, President of SkillsPlus International Inc., possesses over 25 years of experience in identifying training needs. He creates and delivers practical, cost-effective training solutions for GMP, GCP, GLP, QSR, management, and supervisory development and facilitates classes for all levels of the organization. Known for delivering exciting, creative, and highly interactive training sessions, Mr. Dewes is an acknowledged leader in the training field and has spoken at numerous international conventions. Mr. Dewes is the author and publisher of the GMP and QSR Instructor Guides, the GMP Supervisory Training Talks, the extremely popular GMP Trainer's Survival Kit, and many more GMP training resources for various applications. Mr. Dewes earned a Bachelor of Arts in Psychology and Business Administration from Ramapo College of New Jersey, and a Master of Arts in Clinical Psychology, from Towson State University. His graduate study focused on adult learning, behavior change, and communication. SkillsPlus International Inc. works with a team of training and compliance consultants to provide you with current and up-to-date information. Call today to discuss your training and compliance needs.  

     Paula Marks is the CEO and founder of Great Marks Professional Services, LLC. A Quality Assurance professional, Ms. Marks has practical and management experiences in various pharmaceutical, biotechnology, cell-therapy, research and development, and medical device/IVD companies. Paula is a certified training professional with 18 years of experience as a Trainer and Facilitator, and is certified to lead and coach executive professionals in leadership development.  Ms. Marks is a sought after Quality SME and Trainer who is consistently hired to assume key roles related to cGMPs, QSRs, remediation, quality, and compliance deficiencies. She brings a respected ability to interpret FDA Consent Decrees and Warning Letter observations within challenging and difficult manufacturing environments. Her experience on diverse domestic and international teams yields successful outcomes of: removal of Consent Decree statuses, and compliant closure of Warning Letter observations.  Paula's technical expertise includes the: interpretation, administration and set-up of manufacturing operations, quality assurance, quality/compliance systems (specifically, electronic document management systems), deviation and CAPA investigatory activities, aseptic processing, contamination control, regulatory affairs, new product design, and product release testing systems for compliance to regulatory bodies (both domestic and international). Ms. Marks is a member of the: ISPI (International Society for Performance Improvement), ASQ (American Society for Quality) and the Association for Talent Development (ATD, formerly ASTD). Paula has a B.A. degree in Liberal Arts from the Antioch University, and an M.S. degree in Education from Capella University. She is currently working on her Ph.D. dissertation in Education. 

Semantic Site Map

Home  
 > Search our site  
 > Site map by alphabetical topics - a listing of our products and services
 > On-Site Classes - taught at your location
      > GMP Basics
           > Essentials for Pharmaceuticals
           > Essentials for Medical Devices
           > Essentials for API Manufacturers
           > Olympics for CGMP and Biotech Manufacturers - challenging activities
           > Olympics for Medical Device Manufacturers - energizing activities
           > Qualstar Simulation - an advanced CGMP/QSR course
      > Deviations
           > Root Cause Analysis for Better Investigations - solve problems and get results
           > Human Errors - Overcoming The Challenges - tackle human errors as a cause of deviations
           > Deviation Investigation Reports - how to collect data, and write reports
           > Risk Assessment: CGMP/QSR for the 21St Century - design and conduct an FMEA
      > Quality Documentation
           > Procedure Writing for Greater  Process Control
           > Auditing: Internal and External Customers and Suppliers
           > Faster Product Release Through Efficient Batch Record Review
      > Management
           > Surviving an FDA Inspection
           > Meetings for Swift and Aggressive Regulatory Enforcement  
           > Executive Session - What Leadership Needs to Know
           > Management Session - What Every Manager Needs to Know
           > Creating CGMP and QSR Responsibility and Accountability
      > Trainer Skills
           > GMP Trainer Certification - On-site cGMP training for trainers -  Drug & Device Manufacturers
      > Miscellaneous
           > ISO 17025: Calibration Laboratories - details ISO 17025 for calibration laboratories
 > California Exemptee HMDR and DME Providers Certification Course - New - iPad ready!
 > California Designated Representative Certification Course - New - iPad ready!
 > California Designated Representative-3PL Certification Course - New 
 > Florida Designated Representative Study Course
 > E-Learning Courses - online internet-based CBT courses
     > Writing Procedures: for Drug and Device Wholesalers and HMDR
 > News
 > Free Tips - Free CGMP Training Ideas, Tips and Other CGMP Related Stuff
     > 21 CFRs - a listing of these federal regulations
     > Articles - a collection of free tip articles
          > Not All E-Learning Is The Same - select training that is pure, safe, and effective
 > About Us
     > Contact Us
     > Employment - in the form of subcontracting opportunities
     > Clients - some of our clients around the world

 

Alphabetical Listing of Topics

About Us - Some of our personal background.

Articles - Articles of interest to GMP trainers.

Designated Representative and Exemptee Blog

California Board of Pharmacy - Information about the Designated Representative certification class.

California Designated Representative-3PL Certification Course - New 

Clients - A partial list of our clients and customers.

Contacting Us - How to contact us.

Customer Support for Designated Representative Certification Online CBT Classes

Customer Support for Exemptee Certification Online CBT Classes

Customer Support for GMP Online CBT Classes Classes

Department of Health Services - Information about the Exemptee certification class.

Designated Representative - Information about the California Designated Representative certification class. Florida students click here.

Designated Representative-3PL Certification Course - New 

Employment - Subcontract employment opportunities.

Exemptee - Information about the Exemptee certification class.

Exemptee and Designated Representative Blog

Free Tips - A free tips page for customers and visitors. Free upgrade areas are restricted to customers only.

Florida Designated Representative - This is a self study preparation class for the Florida Designated Representative exam. California students click here.

GMP Essentials - This on-site class covers basic CGMP information.

GMP Trainer Certification - On-site cGMP training for trainers -  Drug & Device Manufacturers

GMP Supersite Blog

GMP Train the Trainer - An on-site class training others how to deliver training in CGMP.

Home Page

News - News about our company, products and services.

On Site Classes - Classes that can be conducted at your site.

Search - Basic search feature to explore our website

Subscribe to Free Previews - Call to be enrolled in the latest preview. Preview request number: 415.948.5220.

Technical Support - A knowledge base answering many questions about CBT or e-learning programs, and on line learning management system.

Training Services - The services that we offer.

Writing Procedures: Drug Wholesalers and Home Medical Device Retailers

 

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