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.

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Course

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

Training Days

1 day

Training Location

Available nationally, based on demand

Course Cost

IMDA Skillnet Member: €150
* Cost quoted per person

Register your interest