Quality Training

Quality Systems Regulations (QSR’s) and Good Manufacturing Practice (GMP) Objectives

Objectives

To give personnel working in a regulatory environment an appreciation of the quality system regulations and current good manufacturing practice.

Content includes

By the end of the workshop attendees will:

• Appreciate the quality regulations pertaining to the Medical Device industry
• Understand the context of these regulations within the Quality Management System
• Appreciate how regulations translate into day to day Good Manufacturing Practices and SOP's
• Be familiar with the Quality System Regulations ( FDA’s cfr 820)
• Understand their own role and responsibility in applying the above regulations to their job function
• Understand the role of the quality auditor
• Consider what happens if personnel do not comply with regulations from product and regulatory perspectives
• Appreciate the importance of records and documentation necessary to support a Quality System

Who should attend

Personnel who require an introduction to Quality System Regulations in the medical technologies industry

Upcoming dates:

No training dates available at the moment.