PQS Foundation Training 1 day Virtual Classroom
10 Mar - 2023
€320 Price includes training, all training materials and certificate. Need a quote for In-house Training email us today info@iqc.ie
Introduction
It is essential that personnel involved in the pharmaceutical / biopharmaceutical industry have a good foundation in Pharmaceutical quality systems and are able to 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