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Pharmaceutical Quality and Regulatory Affairs

  • 14 hours
  • 2 days

Overview  

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

Course content  

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

Learning outcomes

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

Certificates 

You'll receive a certificate of attendance from UCL on completion of the course.

Cost

The fee is £1,160 (equivalent to US $1,500). This includes lunch and refreshments.

Partners

Course team

Professor Kevin Taylor

Professor Kevin Taylor

Kevin is Professor of Clinical Pharmaceutics at the UCL School of Pharmacy. He's also Chairman of the British Pharmacopoeia Commission, Chairman of the Chemistry and Pharmacy (CAP), member of MHRA’s Commission on Human Medicines CHM (MHRA's dossier assessing committees).

Dr Khalid Sheikh

Dr Khalid Sheikh

Khalid is a Senior Teaching Fellow at the UCL School of Pharmacy. He's also Director of the Qualified Person Course, Senior Pharma industry manufacturer, expert in use of Statistics (QBD) and Quality Management system (QMS) in pharma industry.

Professor Duncan Craig

Professor Duncan Craig

Duncan is Director of the UCL School of Pharmacy and formulation science researcher.

David Cockburn

David Cockburn

David is former MHRA GMP inspector and Head of EMA (European Medicines Agency) GMP inspectorate.

James Drinkwater

James Drinkwater

James is Chairman of Pharmaceutical and Healthcare Sciences Society (PHSS) and Chairman of Annex 1 revision committee of the PHSS and Pharmaceutical Quality Group (PQG).

Sue Mann

Sue Mann

Sue is Senior Pharma Industry Trainer, Qualified Person, QP Assessor and United Nation’s Trainer for GMP in the South and East Africa.

Dr Susan Barker

Dr Susan Barker

Susan is Former Senior Formulation Scientist, Merck Sharp and Dohme, currently Senior Lecturer at UCL School of Pharmacy and UCL coordinator for pharmacy delivery at New Giza University, Egypt

Course information last modified: 7 Aug 2019, 14:53