WEBINAR SERIES
How to manage mandatory communication of Toxicological risks?
Have you discovered a risk in your product and don’t know what to do next? Our upcoming webinar is here to help! We’ll guide you through the essential steps to take after detecting a risk, making it easier for you to understand and manage the situation.
We’ll cover everything you need to know, from how to address and communicate the risk to effectively mitigating it. We’ll focus on actions that are crucial and mandatory for ensuring your product’s safety and meeting regulatory standards in the pharmaceutical industry.
- Toxicology
- 30 April
- 4 P.M.
- English
Description
When a toxicological risk is identified in a pharmaceutical product, whether during the manufacturing process or at the finished stage, it is crucial to promptly take appropriate action and formulate priority strategies to safeguard the safety and quality of the product. In this webinar, we will delve into essential strategies for accurately assessing and interpreting such risks, effectively reporting and communicating findings, investigating root causes, and implementing corrective measures to mitigate and prevent potential harm to both patients and the environment.
What you'll learn
- What to do when you detect toxicological risk in your pharmaceutical product during the manufacturing process or in the final stage
- Understanding the implications of risk assessment for your product
- Identifying the departments responsible for communicating and evaluating such risks internally
- Conducting thorough investigations to pinpoint causes and implementing corrective and preventive actions
- Navigating mandatory communications if a risk is detected post-market
- Implementing effective follow-up procedures and reviewing both the identified risk and the measures taken to mitigate it
Speaker
Dominiek Rossillion
As the Division Head of Quality Assurance at the QbD Group, based in Belgium, Dominiek brings extensive expertise to the table. He graduated as an Industrial Engineer in Chemistry (minor Biochemistry) and has over 17 years of experience in the life sciences sector. Throughout his career, he has held various roles in manufacturing (Quality, packaging, tech transfer, qualifications, …) and set up multiple successfully accredited QMS systems (ISO9001, 13485. GDP …). After gaining experience in sales, he now leads a team of 90 experts worldwide as the head of the QA Division.
Speaker
Patricia Lugo Mariani
Meet Patricia, our Toxicology Coordinator at the QbD Group. She’s got quite the academic background. She graduated in Chemical engineering with a Master’s degree in Advanced Therapies and Biotechnological Innovation. She’s currently pursuing a PhD in Toxicology and Pharmacology at Complutense University of Madrid.
Patricia has a wealth of experience in microbiological research, including cell cultures, recombinant drugs, and physico-chemical lab work. She’s skilled at characterizing molecules, identifying impurities, and conducting CMC analysis. Additionally, she’s an expert at writing reports for regulatory agencies and has received GMP training. She’s also experienced in EMA and FDA audits.