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
US FDA 21 CFR 820 - QARA Documentation and Training Fee.
|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|
All payments to be made to I 3 Consulting as per the details mentioned in invoice.
Payments in 4 equal installments.