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PQS Inspection Readiness  

This is a self-directed, self-paced E-learning course.  You can pause the training and repeat sections it as many times as you wish.  €199   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 Regulations and Guidelines and the Pharmaceutical quality system and can apply the knowledge to their daily activity. 
Subsequent regulatory inspections will assess the company's overall compliance with regulations and guidelines and the "status" of the PQS (Pharmaceutical Quality Systems). 
This training course will cover the following topics to help you prepare for your next Regulatory Inspection: 
Who should do this course? 
All personnel who interact with the PQS 
Management and Supervisors 
Quality Teams 
Internal Auditors 
This training is delivered by self-paced E-Learning, however IQC (Irish Quality Centre) also offer traditional classroom-based training should you wish to explore this avenue and / or need a quote for In-house Training email us today 
Course Objectives: 
Inspection Logistics 
Role of Inspectors 
During the Inspection 
Auditor / Inspector Facing Do's & Don'ts 
FDA (Food and Drug Administration) Audit Approach Versus EMA (European Medicines Agency) 
Hot Topics and Inspection Findings from FDA/EMA 
Lessons Learnt - Post Audit/Inspection Activities 
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