Customer Benefits

  • Improved Efficiency
  • Reliable Service
  • Training Tailored to Customer Needs
  • Drive Down Costs
  • Quality Driven
  • Adherence to FDA & other Regulatory Agency Compliance

  • Allows Redeployment of Internal Resources

 

Training Courses

Our experienced staff offers training in a number of areas, including but not limited to: 

 

GMP Compliance

  • 21 CFR Part 820
  • 21 CFR Part 210 &211
  • 21 CFR Part 111
  • 21 CFR Part 11

 

 

 

 

 

Regulatory Compliance

  • CAPA
  • Conducting Effective Investigations
  • Introduction to FDA Regulations

 

 

Microbiology

  • Basic Microbiology
  • Contamination Control
  • Bioburden
  • Biological Indicators
  • Disinfectant Applications

 

 

 

 

Aseptic Practices

  • Aseptic Operations

 

Sterilization

  • Ethylene Oxide
  • Radiation
  • VHP
  • Steam
  • Isolator and Barrier Technology
  • Disinfectants

 

 

 

 

 

Environmental

  • Environmental Monitoring Programs

 

Other

  • Calculation and Application of D and Z-value

 

 

Please contact us today with your training needs!

LexaMed Training

LexaMed ’s uniquely qualified experienced professional staff can offer customized training programs on a variety of subjects to meet any specific requirement. Our staff routinely provides training to FDA field inspectors in sterilization technology and is frequent invited presenters at Quality, Regulatory, Engineering, and trade association conferences. Training sessions can be provided on client sites or coordinated in any convenient geographic location.  Additionally, LexaMed offers a training curriculum of four self-contained modules; each module with associated price is listed below:

 

 

Training Modules

Modules offered in English and Mandarin currently

Each Training Module comes with:

Power Point Presentation, Study Guide, Post Training Attendee Assessment, Presenter (optional)

Basic Microbiology $950 US
Basic Microbiology with Presenter $2945 US + travel
Basic Microbiology, Customizable Version $1500 US
Basic Microbiology, Customizable Version with Presenter $3495 US + travel
Environmental and Product Contamination $950 US
Environmental and Product Contamination with Presenter $2945 US + travel
Environmental and Product Contamination, Customizable Version $1500 US
Environmental and Product Contamination, Customizable Version with Presenter $3495 US + travel
Environmental Monitoring and Basic Disinfection $950 US
Environmental Monitoring and Basic Disinfection with Presenter $2945 US + travel
Environmental Monitoring and Basic Disinfection, Customizable Version $1500 US
Environmental Monitoring and Basic Disinfection, Customizable Version with Presenter $3495 US + travel
Clean Room Practices $950 US
Clean Room Practices with Presenter $2945 US + travel
Clean Room Practices, Customizable Version $1500 US
Clean Room Practices, Customizable Version with Presenter $3495 US + travel

 

Sneak a peek!

 

English Module Mandarin Module Training Curriculum

 

Seminars

LexaMed presented "Meet the Experts" on Monday, May 17, 2010 at the Hilton Garden Inn at Levis Commons in Perrysburg, OH. Participants were able to learn from present and past ISO/AAMI Sterilization Working Group Co-Chairs: Carolyn Kinsley, Philip Schneider, Robert Reich and James Kulla. The seminar consisted of four technology update sessions:  (1) Ethylene Oxide Sterilization, (2) Biological Indicators, (3) Radiation Sterilization, and (4) Aseptic Processing / Manufacturing.  More seminars dates, location and content will be announced soon!  These types of subjects can be customized and presented at client-designated sites.