DUBLIN – (COMMERCIAL THREAD)–The “PV Audit Strategy Planning (Pharmacovigilance) – A Practical Approach to Design and Implementation” training has been added to ResearchAndMarkets.com offer.
The European Medicines Agency (EMA) Good Pharmacovigilance Practice (GVP) Guideline, Module IV, requires risk-based quality system audits to be performed at regular intervals to ensure compliance. to established quality requirements and to determine its effectiveness. It includes an audit of the pharmacovigilance system which is covered by the quality system. The GVP modules are applicable to companies based in the EU and to any company marketing medicines on a global scale.
The legally required risk-based audit strategy should cover all PV processes and tasks undertaken or delegated to other departments, MAH affiliates and third parties such as distributors, external service providers, partners (the PV universe). The strategic PV audit plan is used to prepare the PV audit program, i.e. the annual PV audit schedule.
During this two-day workshop, we will review the EMA and FDA requirements for risk-based PV system and quality system audits.
The course will focus on the design of the PV audit strategy, the identification of PV processes and entities subject to PV audit (define the universe of PV audit), development of the assessment methodology risk management, the development of procedures / tools to monitor PV processes and activities, and the implementation of the PV audit strategic plan. In addition, we will examine the methods of quality monitoring and management of third parties performing photovoltaic activities.
By the end of this course, participants should be able to:
Understand the legal requirements and expectations of health authorities for a risk-based audit program and current interpretation. Plan, develop and implement the PV audit strategic plan, which includes the following processes:
Develop a high level PV audit strategy
Identify PV activities and processes subject to PV audit
Develop risk assessment criteria
Identify the universe of PV audit – entities subject to PV audit
Categorize the entities subject to the PV audit
Perform risk assessments
Prioritize the entities to be audited according to the relative risk
Prepare a 3 to 5 year PV audit plan
Identify procedures / tools to monitor third party PV quality
Main topics covered:
Day 01 (9:30 a.m. – 4:30 p.m. EST)
9:30 am: Beginning of the session
Review of FDA and EMEA requirements for risk-based PV audits
The pharmacovigilance system and the quality system
Planning the audit at the strategic level
PV activities and processes subject to PV audit
Risk assessment criteria
The world of PV audit – all entities subject to PV audit
Security data exchange agreements (SDEA) and supplier contracts
Day 02 (9:30 a.m. – 4:30 p.m. EST)
Stability studies (shelf life)
Categorization of entities (PV Audit Universe)
Prioritization of entities to be audited according to relative risk
3 to 5 year PV audit plan
Procedural documents, for example SOP
Identify procedures / tools to monitor PV quality for third party monitoring
Questions and answers
For more information on this training, visit https://www.researchandmarkets.com/r/8ooljy