Training | Consultancy | Auditing 

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  

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 
Places cancelled within 10 working days of commencement must be paid in full. Substitutions may be made at any time at no additional charge. 
Virtual Classroom ISO 13485 Foundation Training
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 
Documentation, records and data integrity 
Change management 
Supply chain management and Good Distribution Practice (GDP) 
Facilities, equipment and services management 
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 
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