Home Header Section
GMP_Starter_BG
Dana Tye, ASQ CQA
Manager, Quality Assurance
Kymanox

CGMP Starter Kit

Curated Kit of Training Presentations (with Editable Versions), Quizzes (with Answer Keys), and GMPPENS
Product Description

As the FDA denotes, “Pharmaceutical Quality affects every American*.” Covering everything from design to monitoring to control, the main regulatory standard for pharmaceutical quality is the Current Good Manufacturing Practices (CGMPs) guiding doctrine. Your team, whether new or seasoned, must be trained on CGMPs in order to ensure the highest level of care is given to the manufacturing process.

This carefully curated package can help you get there. A combination of training presentations and products, this compilation allows one to train employees to be at the forefront of important topics of drug development manufacturing, such as GDP and Data Integrity.

This contains the following trainings/products:

  • CGMP Training
  • GDP Training
  • Data Integrity Training
  • GMPPENS
  • 30 Minute Consulting Conversation with a SME (Optional)

Purchase of this kit will receive the Pro versions of each training listed (please see individual pages for more detail). The retail value of these training packages and products is $1,284.96. However, this entire kit can now be purchased for a one-time offer of $899.00.

*https://www.fda.gov/Drugs/DevelopmentApprovalProcess/Manufacturing/ucm169105.htm

Includes:   Kit
Purchase Price   $899
CGMP Training Powerpoint yes
GDP Training Powerpoint yes
Data Integrity Training Powerpoint yes
GMPPENS (80 Count) GMPpens yes
Optional 30 Minute Consultation with Subject Matter Expert (SME) Consultation yes
Purchase  
Return on Your Investment

Kymanox estimates that it would take a qualified contractor 264 hours (176+88) to complete the work included in this package.

This estimate is based on our extensive experience creating these and other templates and procedures, as well as averages that we have observed across the industry.

Please use the calculator at right if you would like to see how your own calculations affect the dollars and time saved by purchasing our package. You can replace the numbers for "Effort Hours to Complete" as well as "Labor Rate" in order to see differences.

Labor Rate is defined as the overall cost of one employee per hour (including pay rate and benefits), or the overall cost of one qualified contractor per hour. Kymanox estimates this at $40/hour for a qualified contractor.

Available Hours Per Day refers to the number of hours a single resource has to work on the project per day.  8 hours assumes that the resource is fully dedicated to the project.

   
   
Effort Hours to Create This Package
Research & Initial Draft
Review / Revise / Approve
Labor Rate ($ Per Hour)
   
Total (Calculated) Cost:
   
Cost of Package ($)
ROI (> 1 is good)
   
Available Hours Per Day
   
Time Saved:
Dollars Saved:
   
    
   
Related Products: