Agenda

10:00 AM
Welcome and Intro; Regulatory expectations; Lessons learned and real-world costs; Common problems and easy solutions
10:00 AM - 11:30 AM
11:30 AM
Morning Break
11:30 AM - 11:45 AM
11:45 AM
QMS structure; Hierarchy; Process approach
11:45 AM - 12:30 PM
12:30 PM
Lunch Break
12:30 PM - 1:30 PM
1:00 PM
SOP Outline and format
1:00 PM - 2:00 PM
2:00 PM
Afternoon Break
2:00 PM - 2:15 PM
2:15 PM
Understanding user, reader, audience; Exercise 1
2:15 PM - 3:00 PM
10:00 AM
Review; Steps to writing SOPs; Meet regulatory requirements; Provide adequate level of detail on how, who, when, where; Make SOPs clear and concise; Keep it simple
10:00 AM - 11:30 AM
11:30 AM
Morning Break
11:30 AM - 11:45 AM
11:45 AM
Exercise 2
11:45 AM - 12:30 PM
12:30 PM
Lunch Break
12:30 PM - 1:00 PM
1:00 PM
Mistake proofing; Document controls, GMPs
1:00 PM - 2:00 PM
2:00 PM
Afternoon Break
2:00 PM - 2:15 PM
2:15 PM
Implementation and training; Inspection readiness; Exercise 3
2:15 PM - 3:00 PM
3:00 PM
Wrap-up
3:00 PM
Time Zone: (UTC-04:00) Eastern Time (US & Canada) [Change Time Zone]