Good Documentation Practices - SOPs and Batch Records

Stream: Quality Systems, Documentation & Quality by Design

Design and draft SOPs based on industry best practices and GDP, and learn how to apply GDP to elevate your documentation skills.

Learning Objectives:

• Design and draft a standard operating procedure that meets GDP requirements
  
• Explain SOPs and batch records regarding manufacturing control
  
• Apply ALCOA to eliminate ambiguity that leads to operator deviation
  
• Complete a practical drafting exercise and critique it against GDP criteria

Modules:

1. Designing and Drafting an SOP
2. The SOP and its Usefulness in the Pharmaceutical World
3. Good Writing Practices
   
4. Practical Exercise
   
5. Sharing and Conclusions

EST. COMPLETION 45 MIN - E-learning format