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Virtual Event

2024 年 10 月 21 日 1:00 下午 - 2024 年 10 月 25 日 5:30 下午

(Central Europe Standard Time)

4051 Basel, Switzerland

Advanced Pharmacovigilance Audits and Inspections

This advanced 5-half-day virtual live training course will help participants professionally prepare for PV audits and inspections. Experienced instructors who do audits and participate in inspections on a daily basis will share their experience, tips and tricks and best practices.

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Early-Bird rate for DIA Industry Members Available!

DAYS

HOURS

MINUTES

SECONDS

CONTACT US
Send Email +41 61 225 51 51

概览

Using pharmacovigilance audit techniques allows a company to identify any existing gaps or risks in their systems and procedures. This allows them to define and establish priorities and company compliance.

 

Participants will learn how to prepare for an audit and inspection in order to achieve best practices from the moment of facing the auditing/inspection visit notification to the moment of receiving the report and its conclusions.

 

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Participant Testimonials

Calin was extremely informed and gave us absolutely useful practical tips and examples that are memorable enough to avoid bad behaviour during an audit/inspection.

Wonderful sessions, very relevant topics and practical suggestions.

I really enjoyed learning from an expert who could illustrate the theory with many real life cases and explain or clarify when questions were asked.

精选主题

    • PV Audits - QMS Requirements from GVP
    • PV Audit Universe
    • Building a Strategic/Tactical PV Audit Planning
    • Operating Individual PV Audits
    • PV Inspection Readiness
    • Management of PV Inspection
    • Management of Post-PV Inspection Activities

谁应该参加？

  • Professionals most likely to benefit from this advanced course will have experience in:

    • Pharmacovigilance
    • Drug Safety
    • Regulatory Affairs
    • Quality Assurance
    • Risk Management
    • Medical Affairs
    • or holding similar positions within the industry

 

  • A sound knowledge of Pharmacovigilance is a must. A practical experience in audits and inspections is desirable.

学习目标

  • At the conclusion of this course, participants will be able to:

    • Plan pharmacovigilance audits based on risk assessment
    • Identify and address the different areas of a pharmacovigilance system through audits
    • Conduct a pharmacovigilance audit
    • Evaluate audit documentation
    • Manage communication with difficult characters, situations with missing documentation and master extreme situations
    • Handle disagreements on audit findings
    • Identify and follow-up on corrective and preventive actions (CAPAs)
    • Host and manage a pharmacovigilance inspection

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