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Practical Pharmacovigilance Auditing REMOTE LEARNING

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REMOTE LEARNING - this course will be delivered to you live online from the UK. 

If you are wanting to book more than one person onto a course(s) please email courses@therqa.com

Course Information

This well established course will explore key phases of pharmacovigilance auditing. It will address the impact of the EU pharmacovigilance legislation on auditing and provide guidance on auditing pharmacovigilance systems at both the global and local organisational level. This course is designed for pharmacovigilance auditors, auditors new to pharmacovigilance and pharmacovigilance professionals to provide them with insight into developing and/or optimising a pharmacovigilance audit programme. In order to gain maximum benefit from the course, an understanding of pharmacovigilance is advantageous.

This course will assist delegates with

  • A practical approach for the development and conduct of pharmacovigilance audits
  • An enhanced understanding of key pharmacovigilance audit principles, preparation, design and conduct
  • Increased expertise, efficiency and confidence

Course Tutors

Tutors will be comprised from the list below:

Mark Parker
Director, CM Quality Ltd (Course Principal)

Lauren Ewen
Senior Manager, Allergan Ltd 

Mijal Chavda
Director, GVP Quality, Kyowa Kirin International

Bhagti Kavia
Norgine

Jonathan Rowell
Johnson & Johnson

Recent Feedback

"Practical Pharmacovigilance Auditing REMOTE LEARNING is definitely a recommended course for any PV auditor whether experienced or not. I attended the course with a little over a year PV experience and I can say my knowledge base regarding the how and whys of PV auditing has been very enhanced."
"The course topics were relevant and up to date reflecting current regulations and expectations from regulatory authorities. The sample questions included in each of the sections reviewed during the course are very useful for new auditors of PV system and its quality system."
"Tutor was very calm and confident creating an environment that invited delegates to participate in the discussions and share their experiences. Knowledgeable instructor who shared her own professional experience to make the topics more relevant to the course." 

CPD Points

14 Points

Course Programme 

 Please note this course will run in UK timezone.

 

Day 1 
9.15 Welcome and Introductions and Introduction to the Workshops
The objectives of the workshops are defined and process and outputs described. 
 10.00 Pharmacovigilance Audit - Requirements and Expectations
EU PV legislation (relevant Regulations and Directives) and key highlights from Module I, II, IV relating to PV auditing. 
10.45 Break 
11.00
 Audit Planning and Scheduling
Understanding and defining the PV Audit universe, applying risk-based audit strategy, using risk assessment and risk criteria, identifying an audit schedule and resourcing audits. 
11.45 Audit Types, Processes and Preparation
Types of PV audits, QA audit process requirements and tools necessary to execute audit programmes.
Detailed information on how to prepare for audits (by audit type), common features in audit preparation and perhaps a table to show differences on preparation by audit types and planning individual audits (eg preparation, audit planning, audit conduct, audit reporting, CAPA management).
 12.45 Lunch 
13.30 Auditing Affiliates/Local Operating Companies
Auditing the processes and systems in place at local affiliate offices including post-marketing surveillance, clinical trials, medical information, regulatory, sales/marketing etc.
 14.30 Workshop 1 - Audit Schedule
 15.30 Workshop 1 - Feedback
 16.00 Close of day 
 

Day 2 
 9.00 Auditing Case Management Activities
Auditing the processes and systems designed for processing clinical trial and post marketing cases.
 10.00 Auditing the QPPV and the PSMF
Auditing the roles and responsibilities of the Qualified Person responsible for Pharmacovigilance and the Pharmacovigilance System Master File. 
 11.00 Break 
11.15 Workshop 2 - Planning a System Audit 
12.15 Workshop 2 - Feedback 
 12.45 Lunch
13.30 Auditing External Business Partners
Contracts, safety data exchange agreements, outsourcing and oversight by the Marketing Authorisation Holder.
 14.30 Risk Management Systems Part 1, including:
   - Signal management
   - Labeling
   - Risk management plans and risk minimisation
 15.45 Break
 16.00 Workshop 3 - Speed Auditing
16.45 Close of day 
 

Day 3 
9.00 Risk Management Systems Part 2, including:
   - PASS
   - PSUR (PBER) and DSUR
10.15 Break
10.30 Audit Report Writing and CAPA Management
 11.15 Hot Topics
   - PV QMS
   - Market Research/PSP
   - Archiving/Business continuity. 
12.15 Lunch 
 13.00 Regulatory Inspection and Audit of Quality Assurance
Are your audit programme and quality assurance function inspection ready?
Hints and tips on being the interviewee. 
 14.00 Final Wrap Up
An opportunity for open discussion on topics raised during the course or relevant to it. 
 15.00 Close of course 

 

    

 

Course Material

This course will be run completely online. You will receive an email with a link to our online system, which will house your licensed course materials and access to the remote event. 

Please note this course will run in UK timezone.

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
  • Access to an online course group to enhance networking

You will need a stable internet connection, a microphone and a webcam. 

You will also receive a PDF copy of our booklet - "Pharmacovigilance Auditing"

 

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Recommended Products

Booklets

Management of the Training and Competency of Personnel in GxP and Research Environments
Pharmacovigilance Auditing

Courses

P08 The Auditing Course
P11 A Systems Approach to Good Pharmacovigilance Practice
P35 Practical Pharmacovigilance Auditing
RP09 The Remote Auditing Course REMOTE LEARNING

Webcasts

Webcast - Where Does Audit End?

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