Day One:(8:30 a.m - 4:30 p.m)
(8:30 a.m. - 9:00 a.m.: Registration and Breakfast)
Speaker and Participant Introductions(9:00 a.m. - 9:15 a.m.)
Regulatory Requirements and Expectations for Equipment Qualification(9:15a.m. - 9:45a.m.)
- Europe
- FDA
- Global harmonization and expectations
- Management of Documents, Documents Required
Validation policy(9:45a.m. - 10:30a.m.)
- Validation Master Plan (VMP)
- Documents equipment qualification
- SOPs
- Responsibilities
- Validation team
Break/networking(10:30a.m. - 10:45a.m.)
General Aspects of Qualification(10:45a.m. - 11:00a.m.)
Qualification phases, DQ, IQ, OQ, PQ(11:00 a.m. - 12:00 p.m.)
Lunch and networking(12:00p.m. - 1:00p.m.)
Design Qualification (1:00 p.m. - 1:30 p.m.)
Installation Qualification(1:30 p.m. - 2:00 p.m.)
Operational Qualification(2:00 p.m. - 2:30 p.m.)
Process Qualification(2:30p.m. - 3:00p.m.)
Break/networking(3:00p.m. - 3:15p.m.)
Performance Qualification(3:15p.m. - 4:15p.m.)
Final questions/ Comments/Discussion(4:15p.m. - 4:30p.m.)
Day Two:(8:30 a.m - 4:30 p.m)
(8:30 a.m. - 9:00 a.m.: Networking and Breakfast)
Operational Qualificationof existing systems and equipment(9:00a.m. - 10:00a.m.)
- Requalification/validation
(10:00a.m. - 10:15a.m.)Break/networking
Performance Qualification and Process Validation(10:15a.m. - 11:15a.m.)
(11:15a.m. - 12:0p.m.)
- Writing SOPs
- Writing a qualification protocol, content
(12:00p.m.- 1:00p.m.)Lunch/networking
Executing a qualification(1:00p.m. - 2:00p.m.)
Tests and data(2:00p.m. - 3:00p.m.)
(3:00pm - 3:15pm)Break and networking
Documents and writing a qualification report(3:15p.m. - 4:15p.m.)
Final questions/Comments/Discussion(4:15p.m. - 4:30p.m.)