Training Overview

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.

Agenda

Agenda Day 1

•      Introductions (12:30 – 12:45 EDT)

Regulations

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 (12:45 – 02:00 PM EDT)

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 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 – 03:45 PM EDT)

Implementation of a PVQA Audit Programme

·     Exercise – Design a QA Audit Programme for Company A

·     Some questions to consider

End of Day 1 (03:45 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)

·     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

BREAK (02:30 – 02:45 PM EDT )

Audit & Inspection findings (02:45–03:45 PM EDT)

·     Questions to consider

·     Case Study 1

·     Case Study 2

·     Case Study 3

Q&A session (03:45 PM – 04:00 PM EDT)

Certificate of Completion for 2 Days Virtual Training Online on Advanced Pharmacovigilance Auditing & Inspections

Learning Objectives

Upon completing of 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

Who Will Benefit

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


Choose a Purchase Option


$1,295

One Dial-in One Attendee - Live

Early Bird $1295 Regular Price $1985

You get one log-in for the 2 day live virtual seminar for one participant , presentation materials , Certificate and the opportunity to ask questions by phone and email.

$3,995

Live Group-Max. 5 Attendees + 12 month Access

You get Group log-in for the live virtual seminar for 5 participants, presentation materials , Certificate and the opportunity to ask questions by phone and email. On Demand Recorded Access is Included for 12 months for the Group.

$1,899

Corporate Recorded Access Single

2 day Virtual Seminar

You'll have 12 month access to single user log-in for an archived recording of the entire 2 day virtual seminar including the Q&A period. You can log in any time of day or night. You'll also receive all presentation materials, plus an audio recording and transcript for the entire session. Delivery is approximately 48 hours after the session

$2,995

Corporate On Demand Recorded Access – Group

Max. Up to 10 Participants

Up to 10 user Recorded access is allowed from home or office . Attendees will also get free 12 month Access for future training reference purpose. Presentation materials , Certificate and the opportunity to ask questions by phone and email is included.

FDA Faculty

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.

Our Participants Testimonial


The presentation by Carolyn Troiana today was fantastic, both I and the QA Manager (Aaron Neighbour) loved it and had extensive conversation afterward about it. ( FDA Compliance and Mobile Applications Webinar )

Robert Friedland ( IT Manager) NUTEK BRAVO, LLC.

Thank you for providing the information in such detail. It was helpful to gain the perspective of somebody that has implemented these regulations in a working lab. Virtual Seminar on ( Training on Life cycle Management of Analytical Methods and Procedures - according to new FDA and USP guidelines )

Tracey Kessler ( Director of R&D) CEL-SCI Corporation

I felt the seminar was very helpful and provided good insight for DataIntegrity and what the FDA is looking for per the regulations. ( Current Regulatory Thinking on Data Integrity 2 Days Virtual Seminar )

Margaret A. Clifton ( Manager, Quality Systems) CSL Plasma

The presenters subject matter knowledge is extensive which enables information to be shared in detail. (Training Attended on Risk Based Verification and Validation Planning to Meed US FDA and ISO 13485 Requirements )

Stuart Chisholm (Sr. Principal Device Engineer) Teva Pharmaceuticals

About World Compliance Seminars (WCS)

World Compliance Seminars (WCS) is one stop solution for all your pharmaceuticalbiotechnology and medical device certification program needs. The pharmaceutical and medical device training requirements are set forth by the FDA (Food and Drug Administration) and other major regulatory bodies like NIHEMA, as well as numerous European based national regulatory bodies.

These requirements are important to the training of pharmaceutical reps who are responsible for the education, professional development, and on-the-job training. The training is broken down into different sections to cover a wide variety of topics, including pharmaceutical formulation, pharmaceutical transfer processes , GLP, GMP, Clinical ComplianceProcess Validation, Global Regulatory Affairs, Document Management,GMP (Good manufacturing practice) QSR and CMC and many more.

The pharmaceutical and medical device requirements that the FDA has set forth are designed to protect the public's health and safety. Pharmaceutical reps must adhere to all of the regulations and education courses provided by the FDA in order to be considered one of the best in their field. They also must complete ongoing educational opportunities and maintenance programs in order to maintain relevance and career enhancement.

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