Introduction
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).
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 [email protected]
This training course will cover the following topics to help you prepare for your next Regulatory Inspection:
- 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