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Practical Approach to Good Pharmacovigilance Regulatory Inspections

Course Information

This course will deliver the knowledge and skills required for QA and PV to support a successful delivery on all phases of a pharmacovigilance health authority inspection management, from the notification through to inspection response and CAPA implementation stage. The course will provide insight into the complexities and considerations in managing and preparing companies for pharmacovigilance inspections and is designed for PV and QA personnel alike that are, or will be involved in pharmacovigilance health authority inspections. Inspection Readiness and successful conduct of Health Authority inspections is key to success for any pharmaceutical organisation.

This course will provide delegates with skills and knowledge needed to deliver:

  • A practical approach for the preparation and participation in pharmacovigilance inspections
  • An enhanced understanding of the considerations for preparing staff for interviews and the logistical details
  • Clarity on the Roles and Responsibilities in making decisions for the above activities
  • Increased efficiency and confidence leading to cohesive team who work in partnership towards a common goal.

Course Tutors

Tutors will be comprised from the list below:

Mijal Chavda
Director, Otsuka Pharmaceuticals (Course Principal)

Mark Parker
Director, CM Quality Ltd

Course Programme

Please note timings are subject to alteration

   

Day 1

9.15 Registration
 9.30 Welcome, Introduction Introduction to Workshops 
 10.00 Announcement of the Inspection to the MAH
-   Types of inspection 
-   Notification of the inspection to stakeholders
-   Communication with the Inspector
-   Confirmation of dates and location
-   Logistics of the inspection with the inspectors
-   Pre-inspection Document requests
 10.30 Break 
 11.00 In-house Inspection Team 
-   Role of QA with the inspection
-   Senior Management (role)
-   Operational groups (role)
 12.00 Inspection Plan/Agenda
-   Identification of interviewees
-   Notification to business partners/vendors
-   Logistics (location, meeting rooms, backroom)
-   Inspection training/mock interviews 
 13.00 Lunch 
 14.00 Inspection Preparation
-   Gap Analysis
-   Previous inspection comments
-   Changes in the PV system
-   CAPA Review
-   Storyboards
 15.00 Workshop 1 - Storyboards 
 16.00 Workshop feedback 
 16.30 Close of day 
   

Day 2

 9.00 Regulatory Intelligence
-   Local PV Regulations
-   Previous inspections (internal and external)
-   Inspector background expertise/hot topics/experience
 10.00 Management of Document Requests
-   QC and process for document requests
-   During inspection 
 10.45 Break 
 11.15 Close out Meeting and Immediate Actions After the Inspection
 12.00 Lunch 
 13.00 Workshop 2 - Interview Session 
 14.00 Workshop Feedback 
 14.30 Break
14.45 Post Inspection Activities
-   Receipt of the inspection report
-   CAPA development
-   CAPA plan submission 
-   Inspection commitment tracking/CAPA
15.30 Q&A Session
16.00 Close of course

Course Material

Following requests from attendees of previous RQA events we are pleased to offer course material in PDF format for delegates attending this course. 

The advantages of this include

  • Ability for delegates to keep material on a mobile device
  • Ability to review material at any time pre and post course
  • Environmental benefits – less paper being used per course

The material will be emailed in advance of the course and RQA will not be providing any printed copies of the course notes during the training itself. Delegates wishing to have a hard copy of the notes should print these in advance to bring with them. Alternatively delegates are welcome to bring along their own portable devices to view the material during the training sessions.

Additional Requirements
(not included in course fees)

Where the venue is Madingley Hall, accommodation and dinner are available for the dates of the course (we recommend you take this as the location has few nearby facilities). 
If you wish to book additional dates please specify in the ‘accommodation requirements’ box when making your booking and we will check availability with Madingley Hall. Bed and Breakfast is £77*, dinner (three courses with drinks, in the main dining room with other course participants) is £35* (* per night per person) - these can be selected during the booking process.  As part of the booking process we ask for dietary requirements and these will be taken in to consideration by Madingley Hall.  Alternatively bar snacks are available on a pay as you go basis, not bookable through RQA.

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