Standard Operating Procedures
Standard Operating Procedures represent a unique area of operations documentation. A coherently based system goes a long way in ensuring that the people operating in the production and development facility environments have the means to ensure that compliance can be achieved on a consistent basis.
This course will deal with the following content:
1. Why needed, who, When? 7.7. Organization/Control
2. Regulatory requirements 8. Policies vs. Procedures
3. Personnel Responsibilities 9. Key SOPs, examples
4. SOP vs Directions/Forms 10. Training
5. GLP, GCP, GMP requirements 11. Security
6. SOP design 12. Auditing

 


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