DOXPUB 12-0055-SOP
standard published 08/01/2007 by Doxpub, Inc.
standard published 08/01/2007 by Doxpub, Inc.
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 projectCompare the quality of your documents against your industry peersLearn what other companies in your industry are actually doingWho Will Benefit:
Process Biochemistry PersonnelManufacturing ManagersQuality Control Personnel