Count Every Second Until the Event

2024-04-24 8:30

Course Overview

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.

PDE-Based Cleaning Validation and Comprehensive Risk Assessment of Cross-Contamination in Pharmaceutical Manufacturing

Why join the event

Key takeaways of the program

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.

Who Should Attend

An event precisely for you

Heads of R&D
Heads of R&D
Heads of QC & QA
Heads of QC & QA
Manufacturing Heads
Manufacturing Heads
Regulatory Affairs Professionals
Regulatory Affairs Professionals
Pharmaceutical Development Managers
Pharmaceutical Development Managers
Product Maintenance Managers
Product Maintenance Managers

The speaker

Meet your trainer

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.

Dr. Helmut Vigenschow

Dr. Helmut Vigenschow

Senior Pharmaceutical Consultant and Founder

The Curriculum

What you’ll get from this exclusive event

Fresh Content

Knowledge is only useful when it is relevant. This event is based on the latest research, best practices and industry information. As a result, we close events with a strong knowledge base that helps achieve same-day results.


Meet and collaborate with like-minded professionals across the globe. Grow your professional network, exchange ideas, and learn more about the industry with your own peers, together.


Experience comes with practice, and this event will guide you on the right path in becoming a well renowned expert in your field. You will learn through a combination of lecture-based content, real-life case studies, and a more hands-on experience.

Q&A Session

By joining this class, you will be given the opportunity to constantly engage with your peers and raise your concerns, questions, or doubts you may have pertaining to the subject. And, receive well-founded, well-thought-out answers to your every need by leading experts in the industry. 

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