DOXPUB 15-0012-SOP PDF

Summary:

Describes job skill training requirements for Research and Development (R&D) employees performing flow cytometry assays. Intended to assure that all personnel are able to perform their assigned functions and that they meet the training requirements of GMPs and/or Design Control in Medical Device Design. Applies to personnel performing flow cytometry assays including full-time and temporary employees, contract employees and consultants.

Included Sections:

Purpose, Scope, Responsibility, References and Applicable Documents, Materials and Equipment, Health and Safety Considerations, Documentation Requirements, and Procedures

Included Attachments/Appendices:

R&D Flow Cytometry Training Checklist

About This Document:

This is not a generic template, it's a 5-page procedure that was actually created and used in the Laboratory R&D operations of a FDA-regulated establishment. The company-specific information (names, addresses, some images, proprietary product information, etc.) has been redacted but the content and format have been largely preserved.

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