This course is designed to help understand pharmacovigilance Quality Management Systems (QMS) and risk based audits
Since the introduction of the new pharmacovigilance legislation in the EU, QMS and self-audits have become an increasingly important topic.
Companies have been challenged by regulators to implement risk-based audits where continual improvement of processes, systems and compliance to regulations needs to be demonstrated. This is required from the top of the company organisation in all areas of regulatory activity including clinical, pharmacovigilance, sales and marketing, IT and medical services.
This course is designed to help in both the assessments of risk and the whole CAPA and preventative action elements.
Benefits of attending:
- Understand pharmacovigilance quality management systems (QMS) and risk-based audits
- Learn the importance of key performance indicators (KPIs) in your QMS
- Ensure compliance with assessments of risk and your CAPA and preventative actions
- Discuss pharmacovigilance inspections and QMS activities
Programme day one
The audit basics
- The purpose of an audit
- Qualifications of the auditor
- The audit SOP and design
- The difference between audits and inspections
- Audit planning and risk assessments
The legislation and audits
- The requirements to perform company audits
- In-house versus external audits
- What needs to be audited
- Which departments need auditing for safety
- QMS design
- Quality cycles - expectations and deviations
- Quality risk assessments
- Quality failings and corrections
QMS and the audit report
- The audit scope and conduct
- The audit report content
- The grading of audit reports
- Corrective action plans (root cause analysis)
You will be asked to design the QMS for a safety department that has recently been audited. You will need to devise a plan based on any risk elements and audit findings identified and look at designing a QMS approach with KPIs.
Programme day two
Introduction to PV inspections
- Purpose – design
- Roles and responsibilities of the licence holder
- Conduct of regulatory inspections
- Defining risk
- Routine and for-cause inspections
- Triggers for an inspection
- Who should attend the inspection?
The pharmacovigilance inspection cycle
- Pre-inspection questionnaires
- Site visits and telephone audits
- Results and CAPAs
- Inspection follow-up questionnaires
- Follow-up inspections
You will be presented with a series of findings from a regulatory inspection. You will have to look
at the findings and work out priorities, devise root cause analyses and provide detailed corrective and preventative
action plans which will include QMS activities.
Common findings from regulatory inspections
- Grades of findings (and how to grade findings)
- How to grade findings in the same PV area
- Allied findings in other departments
- KPIs versus legislation
- Variations in major authority inspections
Final discussion session
Mr Graeme Ladds,
PharSafer Associates Ltd.
Graeme Ladds, Director of PharSafer, has over 22 years’ experience working in the pharmaceutical industry. Having started his career at Ashbourne Pharmaceuticals in 1989 as Head of Drug Safety & Medical Information, Graeme went on to become Head of Global Pharmacovigilance at Shire Pharmaceuticals.
The last 11 years have been spent in his consultancy company, PharSafer Associates Ltd. During this time, Graeme has been involved in establishing pharmacovigilance in companies, performing audits across Europe and the USA, SOP writing, acting as QP for companies, and helping with regulatory inspections.
11 Thurloe Pl,
The Rembrandt Hotel is located at 11 Thurloe Place, London, SW7 2RS. The hotel’s location in central London couldn’t be better, whether you’re travelling for business or leisure. You’ll be right between two of London’s most fashionable areas – South Kensington and Knightsbridge – within walking distance of museums, theatres, Harrods and Hyde Park.
You can hop on the Tube at South Kensington and take the District, Circle or Piccadilly lines direct to the City of London, Heathrow Airport and all other areas of the city. Look out of your window and you may well see the Victoria and Albert Museum – it’s right across the street.