Extractables and Leachables Testing for Polymeric Materials Used in Pharmaceutical Industry: An Introduction and Strategies in Current Practice

Instructor: Armin Hauk
Product ID: 704340
  • Duration: 60 Min
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.

recorded version

1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Apr-2016

Training CD / USB Drive

One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days

Customer Care

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Read Frequently Asked Questions

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

Instructor Profile:

Armin Hauk-Intertek studied environmental chemistry and parallel to his PhD he conducted a 5 year research work in the field of polymer combustion chemistry. He joined the central analytical department of the former Ciba-Geigy Inc. in 1995. Since 2000, Dr. Hauk-Intertek has been the head of the trace analysis group, the GLP testing facility, the GMP quality control laboratory in Basle, and since 2013, he has been the lead senior consultant for Extractables and Leacheables. He is responsible for organic trace and ultra-trace analysis, special analytics for registration, migration studies, extractable and leachable studies for pharmaceutical packaging, for GMP quality control analysis and stability tests. He is ‘responsible person’ according to the Swiss Pharma Law (HMG) and member of the EDQM Working Group of the Council of Europe working on plastic containers for pharmaceutical use.

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Lifecycle Management of Analytical Methods and Procedures

Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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