Paul PalmerQuality & Regulatory Consultant
Paul is an expert in Pharmaceutical manufacturing and supply chain oversight. He started in 1986 at a manufacturing site with a diverse portfolio of products including, medicinal products (aka pharmaceuticals), medical devices, cosmetics, and casting products. He has maintained the diversity working with all dosage forms from GLP formulation and clinical trials to commercial manufacture and generic the entire product lifecycle throughout his career. Paul has been an active Qualified Person releasing products since 2004 and continues to do so now. He enjoys experiencing a diverse lifestyle that includes teaching various subjects and sharing his knowledge online.
- Timezone: America/Sao_Paulo
- Date: Jan 26 2022
- Time: 12:00 - 13:30
- Jan 26 2022
- 16:00 - 17:30
- Free Live Webinar
How to Pick the Right Tools for a Successful Risk Management
Many pharma and medical device professionals lack a structured and repeatable process for risk assessments. Instead, they carry out risk assessments in a patchy and irregular manner, using FMEA as a default tool.
Risk Management is not only a set of tools; it is also an opportunity for process improvement. A structured, repeatable process that uses the right tools will improve quality, boost productivity, and minimize deviations and observations.
Join this webinar to learn everything you need to know about risk assessments and carry out a GMP compliant one. At the end of the webinar, you will be confident that you know what approach to take and what tools to use for a successful and meaningful risk assessment.
The webinar will help you…
- decide on the best approach for Risk Management on case to case basis,
- choose the right Risk Management tools for your purpose,
- avoid unnecessary deviations and audit observations,
- maintain a solid and compliant GMP quality system.
Who Should Attend?
You should attend if you use risk management techniques as part of your role and would like to discuss use cases to enhance your knowledge to understand better the topic and why there is more to risk assessments than a simple FMEA.
- Executive summary for regulators and industry
- Tools - overall notes
- Basic Risk Management Facilitation Methods
- Failure Mode Effects (Criticality) Analysis (FMEA & FMECA)
- Fault Tree Analysis (FTA)
- Hazard Analysis and Critical Control Points (HACCP)
- Hazard Operability Analysis (HAZOP)
- Preliminary Hazard Analysis (PHA)
- Risk Ranking and Filtering
- Supporting Statistical Tools
- Combination of Tools
- Application - overall notes
- Integrated Quality Management
- Regulatory Operations
- Facilities, Equipment and Utilities
- Materials Management
- Laboratory Control and Stability Studies
- Packaging and Labelling
- Skill Level: Intermediate