Course Content:
Day 1
• Quality
Assurance Manual
o
Make appropriate changes to reflect laboratory operation
o
Enter effective date
o
Obtain required signatures
o
Issue according to SOP procedures
• Standard Operating
Procedures – Quality System
o
Identify priority
•
Document Control SOP should be first
o
Initiate SOP according to SOP procedures
• Issue
one SOP at a time
• Standard Operating
Procedures – Analytical
o
Identify Priority
o
Start with relatively easy procedure
o
Issue according to document control procedure
o
Issue corresponding worksheets
Day 2 thru 5
• Perform testing for
issued SOP
• Document data on issued
worksheet
• Initiate quality control
activities
• Complete analytical
batch
• Forward data to MAAP
representative
Day 6 thru 10
• Initiate corrections
recommended by MAAP representatives
• Initiate filing system
for batch records
Week 3
• Continue SOP implementation
• Communicate with MAAP
representative
• Implement MAAP recommendations
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