Welcome to the immersive world of PDE-Based Cleaning Validation and Comprehensive Risk Assessment of Cross-Contamination in Pharmaceutical Manufacturing. In an industry where versatility and precision intersect, the challenge of managing cross-contamination has taken center stage. Manufacturing facilities, designed to produce an array of drug products, have propelled the issue of cross-contamination risk to the forefront. In an era characterized by multi-purpose plants, a critical need has emerged to implement effective risk management strategies that align with the latest scientific understanding.
The prevailing landscape demands a departure from standardized limits for APIs. Instead, the industry beckons organizations to set specific limits grounded in the toxicological properties of each API. At the heart of this paradigm shift lies the API-specific PDE (Permitted Daily Exposure) values, which shape the permissible extent of cross-contamination. This training embarks on a transformative journey, unravelling the intricate tapestry of PDE-based cleaning validation and comprehensive cross-contamination risk assessment.
As the horizon expands, so does the approach to risk assessment. This training transcends traditional boundaries, shifting the focus from isolated instruments to the entire manufacturing continuum. The manufacturing chain, stretching from material entry to the final dispatch, beckons for comprehensive risk assessment. Shared facilities magnify the complexity, necessitating a profound understanding of potential cross-contamination routes and the imperative mitigation strategies.
Guiding this journey is the eminent Dr. Helmut Vigenschow, a distinguished expert renowned for his depth of knowledge and practical insights in pharmaceutical realms. With a commitment to sharing real-world experiences, Dr. Vigenschow is poised to navigate through the complexities of cross-contamination risk management and PDE-based cleaning validation.
Unveil Cross-Contamination's Intricacies: Explore the nuanced world of cross-contamination in pharmaceutical manufacturing, gaining insights into the intricate challenges and risk management strategies essential for multi-purpose facilities.
Navigate Evolving Guidelines: Decode the latest global guidelines, including EU GMP Chapters, EMA Guidelines, and FDA guidances, and learn to adapt your practices to the dynamic landscape of cross-contamination risk assessment.
Uncover the Expertise of PDE Derivation: Grasp the art of deriving health-based exposure limits (PDE) from complex toxicological data. Gain a clear understanding of the process, enabling you to interpret expert statements by toxicologists and set precise, science-driven limits for effective cross-contamination risk management.
Comprehensive Risk Assessment Artistry: Immerse yourself in the art of comprehensive risk assessment, extending from the entry of materials to the dispatch of the final product. Gain the ability to identify and mitigate potential cross-contamination routes across the entire manufacturing chain.
Strategic Integration for Shared Facilities: Discover strategic risk mitigation measures tailored for shared facilities, understanding the critical role of cross-contamination risk management in maintaining product integrity and patient safety.
Guidance from an Expert: Benefit from the profound insights and real-world experiences of Dr. Helmut Vigenschow, an esteemed expert, as you journey through PDE-based cleaning validation and cross-contamination risk assessment, refining your skills and knowledge under his guidance.
During more than 30 years of professional experience in the pharmaceutical industry, Helmut held senior positions in QC, Project Management, Regulatory Affairs, Pharmaceutical Development and Quality Assurance. He worked for 3 years in India to set up a pharmaceutical development center for ratiopharm GmbH as a greenfield project.Since 2016 he is supporting the pharmaceutical industry as an independent consultant in the areas of Drug Regulatory Affair, Quality Assurance and as QP. Due to his in-depth experience in R&D as well as the GMP area, he perfectly knows the challenges and opportunities at the interface between these fields. Additionally, he acts as a visiting lecturer at different universities teaching Drug Regulatory Affairs.