Elemental Impurities: The New Requirements

Duration: 90 Minutes
This webinar is designed to provide a comprehensive overview of impurities which must be controlled in pharmaceutical products. It will also provide detailed review of the guidance documents related to each of the categories of impurities and strategies to address each, including reporting of test results.
Drug-Related Impurities
Instructor: Gregory Martin
Product ID: 501374
Objectives of the Presentation
  • Identify the various categories of impurities likely to be present in pharmaceutical products
  • Be familiar with the guidance documents related to the various categories, and have an understanding of the requirements included in each
  • Develop a strategy for addressing each of the categories of impurities, if appropriate for the particular dosage form
  • Report the results of testing consistent with expectations of regulatory agencies
Why Should you Attend
Attend this webinar to understand in detail about general impurities (not structurally related to the drug substance), such as residual solvents, elemental impurities, and microbial issues, and drug-related impurities, including process impurities, normal degradation products and potential genotoxic impurities.

Areas Covered
  • Landscape of impurities requiring control in pharmaceutical products
    • General impurities: elemental impurities, residual solvents, microbiological
    • Drug-related impurities: process impurities, degradants, potentially genotoxic impurities
  • Elemental impurities
    • The case for change
    • Current regulatory and compendial status, including EMEA Guidance, USP General Chapters and ICH Q3D
    • Review of heavy metals USP <231>
    • Understanding the coming requirements for elemental impurities <232>
  • Scope, elements included, route of administration, limits
    • Testing methodology
  • Methods in <233> and alternative methods
    • Strategies for compliance
Who can Benefit
Chemists, Supervisors and Laboratory Managers (Research, Quality Control, CRO) and Quality Assurance personnel involved with assuring conformance to elemental impurity requirements, and regulatory affairs/CMC personnel responsible for documenting compliance with elemental impurity and residual solvents requirements.
$300
Recorded Session for one participant
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Live Session - How it works
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  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Greg Martin is the President of Complectors Consulting, which provides consulting and training in the area of Pharmaceutical Analytical Chemistry. Mr. Martin has over 25 years experience in the pharmaceutical industry and was the Director of Pharmaceutical Analytical Chemistry (R&D) for a major PhRMA company for a number of years. In addition, he has volunteered for the USP for over 10 years, and currently serves on the General Chapters - Chemical Analysis Expert Committee, and serves on Expert Panels on Validation and Verification, Residual Solvents and Use of Enzymes for Dissolution Testing of Gelatin Capsules.

He has particular interest in QbD/Lean approaches to dissolution testing, impurity methods, method lifecycle (development/validation/transfer) and instrument qualification, and is passionate about using good science and sound logic to achieve high quality results, consistent with cGMPs, while minimizing resources. Mr. Martin is the author of several papers in the areas of dissolution and analytical method validation, and was the past chair of the AAPS In Vitro Release and Dissolution Testing Focus Group.
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