I will do cgmp documentation and sops

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5.0

Pakistán

Hablo Inglés

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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...

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Ha cumplido con los criterios de alto rendimiento y tiene un historial comprobado de cumplimiento de las expectativas de los clientes.

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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,

Mi porfolio

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    shoaibkhan40795

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    Arabia Saudita

    5

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

    Hasta USD50

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    3 semanas

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    nyxemu

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Reseñas

2 comentarios sobre este Servicio
5.0

(2)
(0)
(0)
(0)
(0)
Desglose de calificaciones
  • Nivel de comunicación del Freelancer
    5
  • Calidad de la entrega
    5
  • Valor de la entrega
    5
Ordenar por
Más relevante
  • S

    shoaibkhan40795

    Cliente recurrente

    SA

    Arabia Saudita

    5

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

    Hasta USD50

    Precio

    3 semanas

    Tiempo

    Útil?
    No
  • N

    nyxemu

    US

    Estados Unidos

    5

    Detail oriented

    USD400-USD600

    Precio

    12 días

    Tiempo

    Útil?
    No

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