DOXPUB 12-0055-SOP

Summary:

Describes the job skill training requirements for employees in a Process Biochemistry Department. Provides the necessary training to assure that all employees are able to perform their assigned functions and meet the training requirements of Good Manufacturing Practices and ISO 9001. Applicable to all full time technical and scientific staff members of the Process Biochemistry Department. Applicable to temporary, contract and consultant employees as determined by the department manager. The need and extent of job skill training for these employees is dependent upon the individuals past work experience and the nature of the work they are performing.

Included Sections:

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

Included Attachments/Appendices:

Process Biochemistry 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 GMP 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:

• Process Biochemistry Personnel
• Manufacturing Managers
• Quality Control Personnel