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This two-day course provides an overview of European regulations and quality standards for the pharmaceutical industry.
You'll learn about current best practice in Europe, dossier assessment and revisions to good manufacturing practice (GMP) guidelines.
It will help you facilitate swift and safe access to markets, through successful submissions and examination processes.
The course is aimed at individuals working for the pharmaceutical industry or regulatory agencies.
This course has been organised by the UCL School of Pharmacy and supported by the Jordan Food and Drug Administration (JFDA).
Who this course is for
This course is aimed at:
- good manufacturing practice (GMP) inspectors
- pharmaceutical quality assurance and regulatory affairs professionals involved in medicine manufacture
Lecture topics will include:
- Regulatory affairs (British and European Pharmacopoeia)
- Challenges in manufacturing
- Data integrity
- GMP inspections
- Pharmaceutical audits
- Self-inspection: preparation for GMP inspections
- Pharmaceutical Inspection Cooperation Scheme (PICS)
- Environmental monitoring
- Analytical methods
- Statistics: Quality by design and Product Quality Reviews (PQR)
- Pharmaceutical Quality Systems: Root Cause Analysis (RCA) and corrective and preventive action (CAPA) management
Teaching and structure
Over the two days you'll:
- listen to talks
- take part in facilitated workshops within small groups
- discuss issues with experts in the field
- network with your industry peers
This course will help you:
- make a submission to the respective regulatory authorities
- prepare for GMP regulatory inspections
- prepare for, conduct and report on effective external audits
- understand good manufacturing practices and pharmaceutical quality systems in the pharma industry, including RCA and corrective and preventive action CAPA
You'll receive a certificate of attendance from UCL on completion of the course.
The fee is £1,160 (equivalent to US $1,500). This includes lunch and refreshments.
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Course information last modified: 7 Aug 2019, 14:53