FDA- DIA Medical Devices Workshop

AGENDA
   Day 1
9:00 Registration and Tea
9:30 Introduction
10:00 Management Controls
1. Management Responsibility
2. Training and Audit
11:15 Refreshment Break
11:30 Design Control (Part I)
12:30 Lunch Break
13:30 Design Control (Part II)
15:00 Documents/Records Control (Part I)
16:00 Refreshment Break
16:15 Document/Records Control (Part II)
16:45 Questions
   Day 2
9:00 Questions and Tea
9:30 Production and Process Control
1. Process Controls
2. Process Validation
10:30 Material Control (Part I)
(Purchasing Controls)
11:30 Refreshment Break
11:45 Material Control (Part II)
(Acceptance Controls)
12:15 Corrective and Preventive Action (Part I)
13:15 Lunch Break
14:15 Corrective and Preventive Action (Part II)
15:45 Refreshment Break
16:00 Questions
16:45 Conference Adjourned