We also recommend:
[Auditing: Internal and External Customers and
Supplies] [Faster Product Release Through Efficient Batch Record
Writing for Greater Process Control
develop more useful procedures that truly guide performance.
State the role of procedures.
Conduct a task analysis and knowledge assessment.
Determine appropriate procedure content.
Evaluate consistency and functionality of procedure
Write SOP statements and instructions.
Identify the procedures intended target audience.
State the regulatory guidelines for writing procedures.
Describe the procedure change control process.
Use procedures for
The role of procedures
How the FDA and our company use
CGMP procedure related observations
Using flow charts
Incorporating skills and knowledge in procedures
Decision making as a process in procedures
Tools and aids to job performance
Sources of procedure information
Step and task sequencing in procedures
Sections of procedures
Company-specific formats and sections
Using each section
Structuring the procedure
Assuring greater retention
Identifying the target audience
Literacy and the procedures
Tricks to make procedures more readable
FDA perspective on procedure readability and
Action words for simplicity
Specific versus general statements
Ranges versus discrete values
Other supporting documents
and Change Control
Review and approval responsibility
Tracking procedures through the change process
Procedures and Training
Using the procedure for training
How to conduct training
the procedure to performance coaching
to learn about how we can customize this outline for any of your site's CGMP
training needs. Standard outlines
may change without notice. To speak with the lead instructor for
this class please call Allan Dewes at 415.948.5220.
a prompt reply to requests and questions: 415.948.5220 |
| Fax: 954.566.5225
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