Quality Systems Regulations (QSR’s) and Good Manufacturing Practice (GMP) Objectives
ObjectivesTo give personnel working in a regulatory environment an appreciation of the quality system regulations and current good manufacturing practice.
Content includesBy 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 attendPersonnel who require an introduction to Quality System Regulations in the medical technologies industry
No training dates available at the moment.