Cross-contamination Risk Assessment in Pharmaceutical Manufacturing MasterClass - EU edition
07-08 December, 2023
Current regulatory requirements to perform a structured assessment of cross-contamination risks.
This training summarizes the current regulatory requirements to perform a structured assessment of cross-contamination risks and presents an approach how this can be implemented in practice.
07-08 December, 2023, Virtual
Time Zone: UTC/GMT+1 /CET
It is common practice in the Pharmaceutical Industry to manufacture multiple drug products in shared facilities with shared equipment. To avoid cross-contamination, all surfaces with product contact are cleaned prior to manufacturing of the subsequent product. According to current EU GMP requirements, the cleaning process has to be validated taking into account the API specific PDE (“Permitted Daily Exposure”) values. The EMA “Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities” finalised 2014 and a Q&A paper published by the EMA in 2018 deal with the topic of cross-contamination and going far beyond cleaning validation. The Aide-Memoires PIC/S PI 043- 1 and PIC/S PI 046-1 published in 2018 are setting common standards for Authority audits. The auditors should assess if a pharmaceutical company has implemented adequate processes to systematically assess and mitigate product- and process-related risks for cross-contamination. The entire process chain from material entry to sampling, dispensing, manufacturing and product dispatch has to be assessed taking into account the 4 basic possibilities of cross-contamination:
Authority inspectors are including these aspects in the focus of their audits and check if companies have implemented well-structured and adequate risk management systems to deal with cross-contamination. This training summarizes the current regulatory requirements to perform a structured assessment of cross-contamination risks and presents an approach how this can be implemented in practice.
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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 Affairs, 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. He has supported several companies with projects assessing cross-contamination risks. Additionally, he acts as a visiting lecturer at different universities teaching Drug Regulatory Affairs.
Who should attend?
• Manufacturing Heads
• Heads of QA
• Heads of QC
• Manufacturing Managers
• QA Managers
• QC Managers
• Pharmaceutical Development Heads
• Technical Directors
"High attention to detail in course content and very well delivered"
Product Development Manager
"Very good training led by two knowledgeable and open experts. Excellent insight given on many complex topics. Interactive and highly useful"
USP PD Team Manager
"Great course, impressed with the knowledge of the trainers and ability to answer wide variety of questions!"
Manager, Senior Investigator
MT Sword Laboratories (BMS)
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