Risk Appraisals for Internal Audits in Pharmacovigilance
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Speaker : GRAEME LADDS
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When : Tuesday, January 07, 2025
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Time : 12 : 00 PM EST
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Graeme Ladds, Director of PharSafer, has over 30 years of experience working in the pharmaceutical industry. Having started his career at Ashbourne Pharmaceuticals in 1990 and becoming Head of Drug Safety & Medical Information, Graeme went on to become Head of Global Pharmacovigilance at Shire Pharmaceuticals and has also served as EU QP PV at many top ten Pharma Companies. The last twenty-one years have been spent in his consultancy company, PharSafer Associates Ltd, a niche CRO specializing in performing pharmacovigilance for many Companies around the world. During this time, Graeme has been involved in establishing Pharmacovigilance in companies, performing audits across Europe and the USA, SOP writing, acting as QP PV for companies, and helping with regulatory inspections.
Graeme is also the inventor of RAPTAR – an automated safety case processing tool that enhances case processing accuracy, and speed and provides cost savings for Companies serious about safety.
The audit program is an essential part of the QMS for the Company and prioritizing the scheduling and content of the audit is critical to the success of assessing the Company's compliance in preparation for a Regulatory Inspection.
The course will look at the Regulatory Inspections of the audits and how the Company can justify the approaches taken in terms of Risk.
The course will also detail those routine aspects that will determine potential risk areas for ensuring Regulatory compliance.
The role of the EU QP PV in such audit programs and risk assessments is also discussed.
Areas Covered
- Risk Appraisals for Audits
- Audit Schedules
- Risk factors for Audits
- EU QP PV and audits
Who Should Attend
- PV Compliance
- Head of Regulatory
- EU QP PVs
- Director/Manager of Pharmacovigilance
- PV QA
Why Should You Attend
It is really essential to understand what needs to be audited first and how frequently so that potential Company risks can be identified and tested to ensure that all aspects are running compliantly.
Additionally, if an audit is performed and there are deficiencies identified from the audit, then there has to be a re-assessment of the risks to determine whether any future audits require more frequent attention.
The webinar will provide background to these aspects which can and will be assessed in any Regulatory Inspection to justify the Company risk approach.
Topic Background
In order to prioritize the number and types of audits that Companies need to perform on their systems and activities, Regulatory Authorities expect Companies to determine which audits are the most important to audit and the frequency of those audits.
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$199.00
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