This training program will offer participants an understanding of the concept of E&L (Extractables and Leachables) studies and about developing an E&L study in a reasonable and pragmatic way - based on regulatory requirements, guidelines and recommendations.
Why Should You Attend:
This webinar will focus on learning and understanding the concept of Extractables and Leachables investigation in pharmaceutical development and QC based on regulatory requirements, national and international guidelines and recommendations. The course will give guidance on how to develop E&L studies in a reasonable and pragmatic way and to avoid pitfalls, to assess Extractables data and to derive lists of relevant Leachables. The similarities and differences of E&L investigations for pharmaceutical contact materials like container closures systems, single use systems in production and also for medical devices will be discussed.Areas Covered in the Webinar:
- Introduction into the field of E&L for pharmaceutical container closure systems (CCS), process contact materials and single use systems (SUS)
- The regulatory background (in US and EU)
- How to design reasonable E&L studies for CCS and SUS
- The assessment of E&L data
- Illustrative examples of E&L studies and their assessment
Who Will Benefit:
Personnel of pharmaceutical companies and their suppliers, in particular those responsible for:- Qualification of Extractables and Leachables
- E&L testing (practically)
- Quality control of packaging materials
- Process development and qualification
Course Provider
Armin Hauk,
