Introduction
It is essential that personnel involved in the pharmaceutical / biopharmaceutical industry have a good foundation in pharmaceutical quality systems and can apply the knowledge to their daily activity. We need all involved industry to be consistently and effectively quality conscious individuals never forgetting the reason for
This course will evaluate and focus on minimum the requirements of a PQS in an international regulatory environment
Who should attend?
All personnel who interact with the PQS
Management and Supervisors
Any responsible personnel involved in the design, development, implementation, and auditing of medical device quality management systems
Cancellations
Places cancelled within 10 working days of commencement must be paid in full. Substitutions may be made at any time at no additional charge.
Course Objectives:
On completion of this pharmaceutical quality systems training course delegates will know and understand:
- Minimum expectations in relation to a PQS (International Best Practice and Guidelines)
- How the PQS is applied throughout the lifecycle of a medicinal product
- Assessing the PQS for effectiveness
- The impact of culture on the PQS
Core Topics covered include:
- Principles and expectations of the PQS
- Product lifecycle
- PQS elements and Risk Management
- International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Q8, 9, and the relationship with ICH Q10
- Management and the PQS
- Personnel
- Documentation, records and data integrity
- Change management
- Supply chain management and Good Distribution Practice (GDP)
- Facilities, equipment, and services management
- Validation
- QP relationships and release scenarios
- Deviation management
- Audits and self-inspections
- Complaints and recalls
- Product quality reviews (PQRs) and management reviews
- Continuous improvement and quality metrics