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21 CFR 820

21 CFR 820 Consultants

Quality System Regulation (QSR) 21 CFR 820 is also known as current Good Manufacturing Practice (cGMP). 21 CFR 820 is for those into the  manufacturing, specification developers, contract manufacturers, re-labellers, re-processors, and distributors pertained to medical devices.

 

As Medical Device Consultants, our US FDA QSR auditing services includes:

  • Gap analysis audit
  • Full or partial internal QSR audit
  • Supplier audit
  • FDA pre-inspection audit
  • FDA QSR mock audit

Benefits of US FDA Post Audit Support

I3CGLOBAL team is the best choice for clients in the Asia Pacific, Middle East, and Europe. We have the knowledge and experience to support Medical Device organizations against FDA warning letters and/or 483 responses. Benefits are as follows:

21 CFR 820

  • Will lay Strong foundation for those implementing for the first time
  • Drafting of important documents
  • Process owner interaction and explanation of all processes
  • Awareness and IQA training
  • Internal Audit support
  • FDA pre-inspection GAP analysis.

Fees (Implementation Support)

  1. Remote documentation of Quality Manual & Mandatory Procedure and relevant templates : 1500 USD in 14 working days
  2. Onsite Implementation by Interacting process owners by travelling to client location : 600 USD /man-day + travel & Accommodation

 

(Post US FDA Inspection)

  1. Understanding of FDA observation and preparing action plan : 400 USD per each observation  (Remote or Onsite)
  2. FDA Response preparation : 600 USD
  3. Support in Closing Observation / 483’s : 1500 USD /man-day + travel & Accommodation