Innovative Process Validation Strategies for Medical Devices
Innovative Process Validation
Strategies for Medical Devices:
Proving Your Processes and
Documentation to the FDA
Bethesda, MD (Washington, DC) • Aug. 26-27, 2014
Agenda
DAY ONE |
|
8:00 a.m. – 9:00 a.m. |
Registration and Continental Breakfast |
9:00 a.m. – 10:15 a.m. |
Process Validation Concepts
Exercise – Setting Process Parameters: Participants will analyze a hypothetical process to determine the input parameters and whether the process should be validated.
|
10:15 a.m. – 10:30 a.m. |
Break |
10:30 a.m. – 12:00 p.m. |
The Requirements Framework
|
12:00 p.m. – 1:00 p.m. |
Lunch |
1:00 p.m. – 2:30 p.m. |
The Regulatory Approach
Exercise – Determine the Inspection Level: FDA Investigators plan the extent of their inspections based on the levels in the Program Compliance Guide. This exercise provides participants an opportunity to apply these ideas and understand the factors that determine the depth of the inspection.
|
2:30 p.m. – 2:45 p.m. |
Break |
2:45 p.m. – 5:00 p.m. |
Installation Qualification (IQ)
Exercise – IQ Checklist: Participants will use the example in the GHTF guidance document to determine if all the essential elements for Installation Qualification are covered.
|
5:00 p.m. |
Session Wrap-up End of Day One |
DAY TWO |
|
8:30 a.m. – 9:00 a.m. |
Continental Breakfast |
9:00 a.m. – 10:15 a.m. |
Statistical Methods (Part 1)
Exercise – Descriptive statistics: Participants analyze some data sets and use the data to calculate descriptive statistics.
|
10:15 a.m. – 10:30 a.m. |
Break |
10:30 a.m. – 12:00 p.m. |
Statistical Methods (Part 2)
Exercise – Determine a DOE alias: In fractional factorial DOE, some of the results have an alias. This exercise shows how to determine the aliases in a design.
|
12:00 p.m. – 1:00 p.m. |
Lunch Break |
1:00 p.m. – 2:30 p.m. |
Operational Qualification (OQ)
|
2:30 p.m. – 2:45 p.m. |
Break |
2:45 p.m. – 4:45 p.m. |
Performance Qualification (PQ)
The Process in Production
Exercise – Applying HACCP Principles: HACCP is a powerful tool that is underutilized in process validation. This exercise demonstrates its application to a process.
|
4:45 p.m. – 5:00 p.m. |
Summary, Conclusions, and Lessons Learned |
5:00 p.m. |
Adjourn Workshop |