FDA- DIA Medical Devices Workshop

Date(s) And Time(s):
Apr 14 2011 8:00AM - Apr 15 2011 4:00PM

Location:
Hotel St. Laum, Ahmedabad
15, Ashram Road
Ahmedabad
Gujarat 380013
India

Overview:

FEATURED TOPICS
• Management Control
• Design Control
• Production Control
• CAPA (Corrective and Preventive Actions)

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

Learning Objectives:
Fundamental understanding of major requirements of quality system regulation

Target Audience:
• Medical device companies
• Medical device suppliers
• Management
• Production
• Manufacturing
• Quality assurance
• Design and Development
• Regulatory aff airs professionals

Event Code:
11663

Contact Information:

Manoj Trivedi, Senior Manager, Marketing & Program Development, DIA
(India) Private Limited; Cell: +91-9819777493
Fax: +91-22-2859-4762,
Email: Manoj.Trivedi@diaindia.org

Pallavi Gokhale, Assistant Manager - Program Development & Operations,
DIA (India) Private Limited; Cell: +91-9004682564
Fax: +91-22-2859-4762;
Email: Pallavi.Gokhale@diaindia.org

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