Extractables and Leachables in Pharmaceutical Manufacturing: Strategies for Compliance

  • Real Time Online Delivery – Live Training Sessions
  • Virtual Attendance for 5 Days Training 
  • Guided Learning Hours – 20 (4 Hrs x 5 Days)
  • Comprehensive Learning Kit

Course Overview

The regulatory requirements concerning the control of extractables and leachables (E&L) have become much more onerous in recent years.

This 5 Day Online Course sets out the regulatory and scientific considerations 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.

Trainer’s Profile

Our expert trainer has experience of 30+years in the pharmaceutical industry and a Fellow of the Royal Society of Chemistry (RSC) with over thirty years’ experience as an analytical chemist.

An expert in sampling and sample preparation, chromatography (liquid and gas), spectroscopy (atomic and molecular) and pharmaceutical dissolution testing. Ex Honorary Treasurer of the RSC’s Analytical Division and led a working group on continuing professional development until July 2016.

A PhD in analytical chemistry, worked at a senior level in a number of industrial laboratories with responsibility for the development of analytical methods capable of quantifying very low levels of organic compounds in a wide range of different sample types. These included pharmaceutical raw materials, drinking water, industrial effluent and marine biota.

One of the respected specialists, helping operating companies to achieve changes and extend best practices & learning by conducting numerous global training courses.

Key Takeaways

  • Learn current regulatory requirements for container/closure qualification from an E/L perspective
  • Develop evaluation program (leveraging suppliers’ documentation and designing analytical studies)
  • Understand the materials of construction – and their composition – of container closure systems, and how they could impact safety and efficacy
  • Identify and apply the principles of quality risk management to E&L studies

Who Should Attend

For personnel of pharmaceutical companies and their suppliers who:

  • Are responsible for qualification of extractables/leachables in quality control
  • Perform leachables/extractables testing
  • Work in quality control of packaging materials
  • Choose and define polymeric, glass and rubber product contact materials
  • Manage materials in process development
  • Choose and define Single Use Equipment for manufacturing
  • Develop materials sourcing strategies
  • Pharma Packaging and Device Engineers
  • Production Engineers, using SU systems
  • Regulatory Affairs Officers
  • Pharma R&D Managers
  • Analytical Chemists, working on E&L
  • Quality Assurance Officers
  • Toxicologists and Safety Assessors

For participation details contact

Samuel Isaac

samuel.isaac@biiworld.com

+1 786 633 1223(Canada)

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Date

Nov 29, 2021 - Dec 03, 2021

Time


13:00 to 17:00 (Central European Time – CET)

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