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FDA News Presentation
- 1. Integrating Pharmacovigilance Into Quality Management System First Annual CAPA Congress Boris Videlov
- 26. Thank you for your attention! www.LinkedIn.com
Hinweis der Redaktion
- Good Morning My name is Boris Videlov, and I am responsible for all quality and compliance-related activities in the Global Drug Safety Department of Forest Research Institute. I will share with you today my views on what constitutes a QMS for Pharmacovigilance and some practical considerations on how to get there. Will provide information on SOME of the key elements of a Pharmacovigillance Quality management System and how to build it.
- FDA: CFR 21 Part 820, 211 Quality System Inspection Technique (QSIT) BARQA - British Association of Research Quality Assurance ASQ - American Society for Quality ISO 9001:2000
- Our metrics are our canaries in the coal mine. However, we need to be able to read our metrics. In the example here, there is a huge difference if the canary’s legs are pointing up - the course of action would be keep digging or “Run!”.
- When I was working on the presentation I was thinking how to depict our process, and this is what I came up with. Apologize to the vegetarians, it can be used as a vegie-grinder.
- Not to be tracked in QMS Subject to regulatory Audits Be mindful of the Regulatory Clock Start Date Compliance with applicable regulations Timeframes to respond to compliance issues – some difficulties Audit Clause - some difficulties Escalation/Penalties - some difficulties from Corporate/Legal Consider using a Contract Management tool Maintain key timeframes reference document/report
- # of queries Completion of SAE form Discrepancies between the CRF and SAE form
- # of queries SAE Form completeness and accuracy – Quality review of samle Discrepancies between the CRF and SAE form
- Signal confirmation Preplanned CAPA, such as labeling changes, “black box” warning, up to withdrawal from the market.
- Inspections & Audits are a important and highly visible source of quality records and most often company-wide CAPA. We always speak about Inspection readiness, but are we always ready? Anything said in Latin sounds profound