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Advanced Pharmacovigilance Auditing and Inspections Course (Recorded)

  • Training

  • 2 Days
  • July 12th 08:30 - July 13th 08:30 EST
  • World Compliance Seminar
  • ID: 5660168

Pharmacovigilance Auditing and Inspections Virtual Live Training Course

This seminar will also have a focus on the risk base approaches in response to COVID - 19 including recent legislation governing the conduct of these activities. PV Audit Strategy Planning course will provide an overview of the European Medicines Agency's (EMA) Guideline on good pharmacovigilance practices (GVP), Module IV requires that risk-based audits of the quality system be performed at regular intervals to assure that it complies with the established quality requirements and to determine its effectiveness.

It includes audit of the pharmacovigilance system which is covered by the quality system. The GVP Modules are applicable to EU-based companies and any company marketing medicinal products on a global basis. The legally required risk based audit strategy shall cover all PV processes and tasks undertaken by or delegated to other departments, MAH affiliates, and third parties such as distributors, external service providers, partners (the PV Universe). The PV Audit Strategy Plan is used to prepare the PV audit program, i.e. annual PV Audit Schedule.

In this two day workshop conference we will review the EMA and FDA requirements regarding Risk Based Audits of the PV system and Quality System. The course will focus on the design of the PV audit strategy, identification of the PV processes and entities subject to PV audit (define the PV audit universe), development of risk assessment methodology, development of procedures/tools to monitor PV processes and activities, and implementation of the PV audit strategy plan. Additionally, we will review methods of quality oversight and management of third parties performing PV activities.

Learning Objectives

Upon completing this course, participants should be able to:

  • Understand the legal requirements and health authority expectations for a risk-based audit program and current interpretation. Plan, develop and implement the PV Audit Strategy Plan, which includes the following processes:
  • Develop a high-level PV audit strategy
  • Identify the PV activities and processes subject to PV audit
  • Develop risk assessment criteria
  • Identify the PV audit universe - entities subject to PV audit
  • Categorize the entities subject to PV audit
  • Perform risk assessments
  • Prioritize entities for audit according to relative risk
  • Prepare a 3-5 year PV audit plan
  • Identify procedures/tools to monitor PV quality of third parties

Course Content

Agenda Day 1Introductions
  • ICH- Guidance US/EU/Japan
ICH Q10 - Pharmaceutical Quality System
  • Life time of a Product
  • Resources to monitor the QS
ICH Q9 - Quality Risk Management
  • Risk Management Methods and Tools
  • ICH E2- Clinical Safety Data Management
  • 21 CFR Part 314:80/81
EU GVP Module IV (R1) - PV audits (12AUG2015)
  • Risk Based approach
  • Strategic Level (2-5 years)
  • Tactical level
  • Operational level
Pharmacovigilance System Master File
  • GVP Module II - PSMF (31MAR2017)
  • Main body covers the PV QMS including QA
  • Annex G - Quality System:
  • Audit schedules
  • List of audits conducted and completed
  • Significant CAPAs
Background & Design of QA Programme
Strategic Level- Plan to cover:
  • All pharmacovigilance activities
  • The Quality Management System (QMS) for pharmacovigilance activities
  • Interactions with other company departments, as appropriate (GMP, Regulatory Affairs)
  • Pharmacovigilance activities conducted by affiliated organisations
  • Pharmacovigilance activities conducted by third parties
Strategic Level
  • Service Level Agreements - outlines
  • SDEA
  • Key Performance Indicators (KPI)
Tactical Level PlanningTactical AspectsOperational LevelPre-Audit QuestionnairesBREAK
Case study/Exercise with Q&A
  • Implementation of a PVQA Audit Programme
  • Exercise - Design a QA Audit Programme for Company A
  • Some questions to consider
End of Day 1Agenda Day 2Q&A session from Day 1
PV Inspections
  • EU GVP Module III - PV Inspections (16SEP2014)
  • EMA Remote PV Inspections - During crisis situations(SEP2020)
  • MHRA guidance on Remote Inspections
  • Routine Inspections
  • Pre-Authorisation Inspections
  • ‘For Cause’ Inspection
  • Preparing for a PV Inspection
  • Tools
  • Inspection Checklist (Plan) should cover
  • Document Request form
  • Metrics from MHRA 2020 Symposium, London
  • SMART Responses when drafting CAPAs
Audit & Inspection findings
  • Questions to consider
  • Case Study 1
  • Case Study 2
  • Case Study 3
Q&A session (Certificate of Completion for 2 Days Virtual Training Online on Advanced Pharmacovigilance Auditing & Inspections

Course Provider

  • Michael Ramcharan
  • Michael Ramcharan,
    Course Instructor ,
    Greater Guildford Area, United Kingdom

    Michael Ramcharan has 30 years of experience in Quality Assurance having worked with multinational Pharmaceutical and Clinical Research Organisations (CRO) mainly in the GCP and GPV areas. He has conducted a wide variety of audits (both On-site and Remote) globally, and managed various risk-based audit programmes. He has also hosted and supported many European Regulatory Authority Inspections (eg; MHRA, EMA, Local EU country Inspectorates).

    Michael’s audit experience has also extended to successfully designing and implementing various audit and Training programmes, and for providing general Quality Management System support. He is currently a member of the Pharmaceutical Information and Pharmacovigilance Association (PIPA), Research Quality Assurance (RQA), and an active committee member of the RQA South West, UK Regional forum group.

Who Should Attend

This course is designed for people with some PV experience and tasked with developing, maintaining, updating and/or reviewing the PV quality system audit strategy plan, risk assessment and/or the annual PV audit schedules. It is also beneficial for staff responsible for the quality oversight of third parties conducting PV activities.

The following personnel will benefit from the course:

  • PV Quality Assurance Staff
  • PV Compliance professionals
  • Quality auditors
  • Pharmacovigilance Auditors
  • Relevant Pharmacovigilance Staff
  • PV Service Provider Relationship Managers
  • MAH Affiliates responsible for Pharmacovigilance