Extractables and Leachables Control Strategies
Extractables and Leachables Control Strategies

Course Description

Regulatory expectations for the control of extractables and leachables (E&L) have evolved greatly in recent years. This three-day course sets out the regulatory and scientific considerations concerning E&L in a logical, stepwise manner and offers practical advice for compliance. The course answers questions such as: “When is an extractable/leachable study necessary?”, and “How do I choose appropriate extraction conditions?”. Regulators will expect a risk-based approach to compliance, and the steps involved in an E&L risk assessment are described. The course draws on information contained in current regulatory guidance (such as ICH Q3E) as well as influential publications from bodies such as the Product Quality Research Institute (PQRI), BioPhorum and the Extractables & Leachables Safety Information Exchange (ELSIE).
  • General approaches for the control of pharmaceutical impurities
  • Options for setting control limits (the Safety Concern Threshold)
  • Applying the principles of quality risk management to E&L
  • Common leachables from glass and plastic materials and their impact on product quality
  • Designing an appropriate extractables study
  • Analytical approaches for the detection, identification, and quantitation of E&L
  • Specifying the Analytical Evaluation Threshold (AET)
  • Common analytical errors in E&L studies
  • The ELSIE approach to risk-based E&L control

By attending this course, you will:

  • Understand how extractables and leachables fit into the wider context of pharmaceutical impurities
  • Be able to identify the common types of leachable contaminants associated with different packaging materials
  • Know how to perform an extractables/leachables risk assessment
  • Be aware of current EU, US and WHO guidance on extractables and leachables
  • Appreciate the risks from glass and plastic materials
  • Understand the analytical approaches to extractables and leachables analysis
  • Be aware of common analytical errors that can affect data reliability
  • Become familiar with the Extractables and Leachables Safety Information Exchange (ELSIE) and its approach to controlling leachables risk

Extractables and Leachables Control Strategies

22 - 24 October 2024, Live Online Training
Regular price €1.850,00
Unit price
per 
Dr Mark Powell

Dr Mark Powell a Fellow of the Royal Society of Chemistry (RSC) with over thirty years’ experience as a senior analytical chemist. Mark has served as both Honorary Secretary and Honorary Treasurer of the RSC’s Analytical Division and led a working group on continuing professional development until July 2016.

START TIMES

1:30 PM Vienna time

12:30 PM London time

7:30 AM New York time

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Course Description

Regulatory expectations for the control of extractables and leachables (E&L) have evolved greatly in recent years. This three-day course sets out the regulatory and scientific considerations concerning E&L in a logical, stepwise manner and offers practical advice for compliance. The course answers questions such as: “When is an extractable/leachable study necessary?”, and “How do I choose appropriate extraction conditions?”. Regulators will expect a risk-based approach to compliance, and the steps involved in an E&L risk assessment are described. The course draws on information contained in current regulatory guidance (such as ICH Q3E) as well as influential publications from bodies such as the Product Quality Research Institute (PQRI), BioPhorum and the Extractables & Leachables Safety Information Exchange (ELSIE).
  • General approaches for the control of pharmaceutical impurities
  • Options for setting control limits (the Safety Concern Threshold)
  • Applying the principles of quality risk management to E&L
  • Common leachables from glass and plastic materials and their impact on product quality
  • Designing an appropriate extractables study
  • Analytical approaches for the detection, identification, and quantitation of E&L
  • Specifying the Analytical Evaluation Threshold (AET)
  • Common analytical errors in E&L studies
  • The ELSIE approach to risk-based E&L control

By attending this course, you will:

  • Understand how extractables and leachables fit into the wider context of pharmaceutical impurities
  • Be able to identify the common types of leachable contaminants associated with different packaging materials
  • Know how to perform an extractables/leachables risk assessment
  • Be aware of current EU, US and WHO guidance on extractables and leachables
  • Appreciate the risks from glass and plastic materials
  • Understand the analytical approaches to extractables and leachables analysis
  • Be aware of common analytical errors that can affect data reliability
  • Become familiar with the Extractables and Leachables Safety Information Exchange (ELSIE) and its approach to controlling leachables risk

"Trainer is very competent and has the complete knowledge of the matter."

– Senior Process Expert, B. Braun

"It is not at all frequent to find this grade of preparation and reaction to specific cases such as the ones presented. I'm enthusiastic! Thanks really."

– Tech Transfer Lead, Novartis

"Thank you for sharing all the links and informative material. Very professional organization and execution."

– Manufacturing Manager, Thermo Fisher Scientific

"The trainer was very knowledgeable about the topics and was able to answer all questions."

– Drug Product Subject Matter Expert, Pfizer

"Excellent work of the lecturer, good materials, clear explanations."

– Clinical Pharmacologist, Boehringer Ingelheim

Extractables and Leachables Control Strategies

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