We are happy to announce our first webinar of the series we have prepared!
In particular, our Carla Landolfi, European Registered Toxicologist (ERT) and the Founder & CEO of ToxHub Srl, will delve into the different nuances of Permitted Daily Exposure (PDE) in the context of cleaning validation in shared facilities.
Cross-contamination refers to the unintended transfer of substances from one product to another, potentially compromising the quality, safety, and effectiveness of pharmaceutical products. The implications of cross-contamination have an impact not only on the safety and efficacy of the contaminated products but also on the trust and credibility of the manufacturing facilities and, by extension, the entire pharmaceutical industry. It can lead to serious health risks for patients, including allergic reactions, toxicity, or reduced therapeutic efficacy. To mitigate these risks, regulatory bodies worldwide have established stringent guidelines for cleaning validation and contamination control.
Among the key strategies for managing cross-contamination is the establishment of Health-Based Exposure Limits (HBELs) based on PDE calculation. PDEs play a pivotal role in the cleaning validation process, providing a scientifically derived limit for the acceptable intake of residual substances, ensuring that any potential cross-contamination remains within safe levels. Determination of a PDE involves hazard identification by reviewing all relevant data, identification of critical effects, determination of the no-observed-adverse-effect level (NOAEL) of the findings that are considered to be critical, and use of several adjustment factors to account for various uncertainties, according to the EMA requirements.
In the presentation, we will delve deeper into the concept of PDEs, their determination, and their critical importance in the validation of cleaning procedures to prevent cross-contamination, safeguarding patient health, and maintaining the integrity of pharmaceutical products.
Speaker
Carla Landolfi
European Registered Toxicologist (ERT); Toxicology Risk Assessor; Founder & CEO of ToxHub Srl.
As a European Registered Toxicologist, Carla Landolfi has spent 25 years within the pharmaceutical industry as Head of Toxicology at Angelini, among others. Having expertise in pharmaceuticals and medical devices safety assessments (MDR/FDA/GLP/ISO), she is the founder of ToxHub, specialized in toxicological risk assessment and regulatory strategy consulting. She is a frequent author of publications and founding editor of Archives of Clinical Toxicology.
Date, Time and Language
April 4th, 2024, from 16.00 to 17.00 PM, CET (Central European Time).
This webinar will be held in English.
The Webinar will address the following topics:
- PDE definition,
- Regulatory Guidance,
- Factors Influencing PDE,
- Calculation Methods,
- Importance of Toxicological Data,
- In silico approaches for PDE determination,
- Case Studies.
Are you interested in joining our webinar? To register, simply fill out the registration form below with your information! Registration is free and open till April 3rd.