21 CFR 820




United Sates Food and Drug Administration instructs certain type of medical device manufacturer to develop a Quality Management System (QMS) commensurate with:

  • Risk presented by the device.
  • Complexity of device and manufacturing processes.
  • Size and complexity of organization.

Manufacturer includes but is not limited to those who perform the functions of contract sterilization, installation, relabeling, remanufacturing, repacking, Designers and initial distributors of foreign entities performing these functions.






QARA provides Guidance and training online for successfully Implementing 21 CFR 820.

QARA expert assistance online is very economical and fast. Organizations interested to work with us can appoint one dedicated person to interact with consultant by telephone/Skype/G talk & Email.


THE BEST AND SIMPLE WAY TO GET YOUR ORGANIZATION SUCCESSFULLY COMPLETES FDA 21 CFR 820 (GMP) AUDIT.

QARA and its team makes it true by ONLINE and ONSITE consultancy

It is Fast, Economic and convenient to employees in charge of Implementing GMP in the organization.

No matter where you are OR where we are....

Contact us to get started.

 





 

What we do for you?

  • Understanding your activities and Prepare the Implementation program with time schedule.
  • Identify the necessary procedures
  • Supply of draft procedures and formats
  • Supply of Draft Quality Manual
  • Awareness Training
  • Internal auditing
  • Quality audit
  • GAP Analysis

21 CFR 820 - QARA Documentation and Training Fee.

 

SL.NO Activity FEE Tenure
01 Draft and provide necessary procedures after understanding your business and process based on the scope of 21 CFR 820 $ 849 14 Days
02 Draft and provide Quality Manual after Understanding of your scope of 21 CFR 820 $ 549 7 Days
03 Supply of relevant Forms to support procedures $ 449 7 Days
04 Awareness Training for 8 -10 members $ 249 7 Hrs
05 Internal Auditor Training for 8-10 members $ 349 7 Hrs
06 Verification of Procedures and Quality Manual $ 349 5 Days
07 Internal Audit $ 249 1 Day
08 Calibration and Validation guidance $ 249 4 Hrs
09 DHR Guidance and Format $ 1000 14 Days
10 Risk Analysis Check List $ 249 3 Days
11 ISO 62304 Implementation $ 1500 7 Days
12 Additional Consultation and guidance $ 100 2 Hrs
13 Pre – FDA Inspection Preparation ( Those clients received inspection notices from FDA ) $ 3000 + Travelling + Lodging 2 Days
14 Closing of NC’s (Post – FDA Inspection) $ 500 1 Day

Payments

All payments to be made to I 3 Consulting as per the details mentioned in invoice.

Payments in 4 equal installments.

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