Stability Programs for Leachable Impurities

Instructor: Wayland Rushing
Product ID: 704685
  • Duration: 60 Min
This training program will closely examine what are extractables and leachables. It will focus on how to design and implement leachable stability programs, including the requirements for leachable stability programs, developing and validating methods for use in leachable stability programs, and drug product impurities vs. leachable impurities.

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: Jun-2018

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

Fax: +1-650-362-2367


Read Frequently Asked Questions

Why Should You Attend:

Leachables are impurities which originate from contact surfaces (typically the final container/closure) of the drug product. As with drug product related impurities it is important to monitor the leachables over the shelf-life of the products to ensure patient safety. Performing leachable stability studies can be challenging and is generally less understood than for typical drug product related impurities. There are several key differences between leachables and drug product related impurities which must be understood in order to design an effective stability program.

This presentation will cover: what are leachables, where they come from, what are the similarities and differences in comparison with drug product related impurities and what are the method and stability requirements.

Learning Objectives:

  • Understanding where leachables come from
  • Learning the regulatory expectations for leachable stability programs
  • Understanding analytical method requirements for leachables

Areas Covered in the Webinar:

Background and Overview of Leachables

  • What are extractables and leachables
  • Where do they come from
  • Why is there concern

How to Design and Implement Leachable Stability Programs

  • What are the requirements for leachable stability programs
  • How to develop and validate methods for use in leachable stability programs
  • Drug product impurities vs. leachable impurities
  • Common pitfalls associated with leachable stability programs

Who Will Benefit:

  • Drug Development Professionals
  • Stability Managers
  • CMC Analytical Managers
  • Manufacturing
  • Quality Assurance
  • Regulatory Affairs
  • Program Management
Instructor Profile:
Wayland Rushing

Wayland Rushing
Sr Scientific Advisor, ABC Laboratories

Dr. Wayland Rushing is a technical expert in chemistry, manufacturing and controls (CMC) program design, analytical development and regulatory submissions. Over his 15-year career, he has led CMC development programs for a wide array of biopharmaceuticals, including parenterals, inhalation drugs, and other pharmaceuticals with complex delivery systems.

Dr. Rushing is a subject matter expert in HPLC and GC method development and validation, extractables and leachables program design and regulatory submission requirements; has drafted multiple IND and NDA submissions; and assists ABC clients in responding to FDA deficiency letters. He currently serves on Parenteral Drug Association (PDA) advisory committees for Technology Transfer and Elastomeric Closures and Seals Presentation Summary and was co-author of PDA TR 65, Technology Transfer.

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Effective Quality Oversight of Pharmaceutical Contract Manufacturing Organizations (CMOs)

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.

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