DOXPUB 09-0094-SOP

Summary:

Describes the job skill training requirements for employees in the Quality Assurance/Quality Control Department performing microbiology quality assays. Intended to provide the necessary training to assure that all employees are able to perform their assigned function and to meet the training requirements of Good Manufacturing Practices. Applies to technical and scientific personnel in the QC/QA Department performing microbiological 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:

QA/QC Microbiological Training Notification, QA/QC Microbiological Skills Training Checklist

About This Document:

This is not a generic template, it's a 6-page procedure that was actually created and used in the Quality Control 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.

Reasons to Buy:

• Use it as a starting point for your own documentation project
• Compare the quality of your documents against your industry peers
• Learn what other companies in your industry are actually doing

Who Will Benefit:

• Quality Assurance Managers
• Manufacturing Managers
• Quality Control Personnel