I will do cgmp documentation and sops

Alcune informazioni sono riportate in lingua inglese.
5,0
5,0

Pakistan

Parlo Inglese

128 ordini completati

ISO 13485, MDR 2017 745, FDA Regulatory Affairs, Medical Device QMS Expert

Hi, Greetings! I am a Medical Device Regulatory and QMS expert with over 20 years of experience in regulated industries. I am an IRCA Approved Lead Auditor for ISO 9001:2015 & ISO 13485:2016 and speci...

Livello 2

Ha soddisfatto criteri di prestazioni elevate e ha una comprovata esperienza nel soddisfare le aspettative dei clienti.

Informazioni su questo servizio

Hi, Greetings!

If you are in need of top-notch Standard Operating Procedures (SOPs), a comprehensive GMP documentation plan, consultation services, and assistance with FDA Registration, I am ready to collaborate with you.


With my extensive experience in the field, I specialize in providing comprehensive solutions for various industries. Whether you require SOPs, GMP documentation, or guidance on compliance and FDA Registration, I am well-equipped to meet your needs.


I will prepare all cGMP documents, protocols, and SOPs in accordance with FDA regulations such as 21 CFR 820, as well as international guidelines.


The following procedures will be developed, but not limited to, the ones listed below:


Facility Layout

Manufacturing Processes

Insect & Rodent Control

Master Validation Plans

House Keeping / Sanitation

Internal Audits

Calibration & Maintenance

Device Master Record (DMR)

Device History Record (DHR)

FDA Inspections

Material/Product Acceptance

Manufacturing Inspection & Checklist

Employee Training

Document Control & Records

Analysis of Data

Nonconformance

Recall

Complain Handling etc.


Looking forward to working with you to achieve operational Excellence.


Regards,

Il mio portfolio

Recensioni

2 recensioni per questo servizio
5,0

(2)
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Valutazione dettagliata
  • Livello di comunicazione del venditore
    5
  • Qualità della consegna
    5
  • Valore della consegna
    5
Ordina per
Più rilevante
  • S

    shoaibkhan40795

    Cliente abituale

    SA

    Arabia Saudita

    5

    Excellent work and very professional service. The communication was smooth, timely, and highly efficient. I truly appreciate the effort

    Fino a 50 USD

    Prezzo

    3 settimane

    Tempo

    Utile?
    No
  • N

    nyxemu

    US

    Stati Uniti

    5

    Detail oriented

    400 USD-600 USD

    Prezzo

    12 giorni

    Tempo

    Utile?
    No
Recensioni

2 recensioni per questo servizio
5,0

(2)
(0)
(0)
(0)
(0)
Valutazione dettagliata
  • Livello di comunicazione del venditore
    5
  • Qualità della consegna
    5
  • Valore della consegna
    5
Ordina per
Più rilevante
  • S

    shoaibkhan40795

    Cliente abituale

    SA

    Arabia Saudita

    5

    Excellent work and very professional service. The communication was smooth, timely, and highly efficient. I truly appreciate the effort

    Fino a 50 USD

    Prezzo

    3 settimane

    Tempo

    Utile?
    No
  • N

    nyxemu

    US

    Stati Uniti

    5

    Detail oriented

    400 USD-600 USD

    Prezzo

    12 giorni

    Tempo

    Utile?
    No