The "Advanced Pharmacovigilance Auditing and Inspections Course" training has been added to ResearchAndMarkets.com's offering.
This seminar will also 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 of this course, participants should be able to:
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:
Key Topics Covered:
Agenda Day 1
Introductions (12:30 - 12:45 EDT)
Regulations
ICH Q10 - Pharmaceutical Quality System
EU GVP Module IV (R1) - PV audits (12AUG2015)
Pharmacovigilance System Master File
Strategic Level- Plan to cover:
Strategic Level
Tactical Level Planning
Tactical Aspects
Operational Level
Pre-Audit Questionnaires
BREAK (02:00 PM - 02:15 PM EDT)
Case study/Exercise with Q&A (02:15 PM - 03:30 PM EDT)
End of Day 1 (03:30 PM EDT)
Agenda Day 2
Q&A session from Day 1 (12:30 PM - 01:00 PM EDT)
PV Inspections (01:00 PM - 02:30 PM EDT)
Audit & Inspection findings (02:30-02:45 PM EDT)
Q&A session (02:45 PM - 03:30 PM EDT)
Certificate of Completion for 2 Days Virtual Training Online on Advanced Pharmacovigilance Auditing & Inspections
For more information about this training visit https://www.researchandmarkets.com/r/eqen29