How to ensure an Effective Quality System for Pharmacovigilance Activities | @InnoVigilance Webinar

I was honored to have been invited as a guest speaker for this incredibly valuable webinar, which was organized and published by @InnoVigilance on 29-Aug-2021. Through InnoVigilance Academy, Dr. Omar Aimer along with Dr. Shams Qaend runs great training programs for emerging professionals in Pharmacovigilance and Drug Safety. They also organize monthly webinars on crucial topics in the field. Make sure to follow their channel on the below link and connect with them on LinkedIn. InnoVigilance Youtube Channel: https://www.youtube.com/c/InnoVigilance InnoVigilance LinkedIn Page: https://www.linkedin.com/company/innovigilance/ Connect with me (KishanThePVGuy) on LinkedIn: https://www.linkedin.com/in/kishan-nandha-cba-271aa934/ Do you need guidance on writing PADERs? If yes, check this out - https://www.amazon.com/Comprehensive-PERIODIC-ADVERSE-EXPERIENCE-PHARMACOVIGILANCE-ebook/dp/B07G25V9H5/ref=sr_1_2?dchild=1&keywords=kishan+nandha&qid=1622699251&sr=8-2 This webinar covers Quality System requirements in Pharmacovigilance activities. Following is the comprehensive list of questions/topics that were discussed in this webinar: 1. How do you define Quality System for Pharmacovigilance activities? Why is it important and what are its objectives? 2. How should the Quality System be documented? Can you shed some light on the necessity of controlled documents, procedures and procedures, and any challenges that you may see in this area from time to time? 3. What are the requirements related to training activities in a PV Quality System? Can you tell us some things to consider? 4. How do we manage compliance and quality in our day-to-day PV activities? What can be some tools that we can use to keep a track of our compliance? 5. We know, we have a lot of outsourcing in the PV space. What are some crucial things to keep in mind when outsourcing any or all activities to a vendor? And how do we ensure that they are meeting the compliance requirements? 6. Can you tell us briefly about the requirements for a CAPA process in the Quality System? What would you say are the basic elements in this process? Are there any challenges or pitfalls that you would like to share? 7. When it comes to documentation and record management of activities, it has been more and more important to abide by Data Integrity principles and Good Documentation Practice? Can you share your experience on this subject? 8. Can you tell us some things about Business continuity in Pharmacovigilance? What are the Quality System requirements for having a Business Continuity Plan?