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FDA Validation and Compliance 

To promote business continuity and compliance with regulatory guidelines, we offer a comprehensive line of validation, compliance, and quality services to clients. Our team of subject matter experts is well versed on the most up-to-date guidance from the FDA and can bring a practical understanding of interpretations required to mitigate risk enterprise-wide.

Capabilities cover the full range: 21 CFR Part 11, Part 210/211, GAMP5, Part 320/820, Part 58, and across the entire spectrum: CSV, GMP, GLP, GCP, GDP, GxP, ICH, CQV, equipment/utilities/facilities, process/cleaning/packaging.

Engineering design qualification services include:

  • Design qualification
  • Conducting vendor audits, FAT (factory acceptance testing), and SAT (site acceptance testing)
  • Software developer assessment
  • Specifications – user requirements, functional requirements, and detailed design
  • Commissioning

For more information, contact:

Daniel Rhodes
Phone:: (760) 458-4505
E-mail:: 
daniel.rhodes@kellyservices.com

Michael Ruchman
Phone:: (858) 232-7110
E-mail:: 
michael.ruchman@kellyservices.com

 

Careers in Engineering

Careers in Engineering

Request Staff

Submit your request for talent.
Find People

Request Staff

Submit your request for talent.
Find People

Request to Contact

How can we help you?
Request to Contact

Request to Contact

How can we help you?
Request to Contact