Faculty: Kelly Thomas ‎ ‎ ‎ ‎ ‎‎ ‎ ‎ |‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ Code: FDB3418


  • Date: 3/4/2024 11:00 AM - 3/4/2024 12:30 PM
  • Time zone: Eastern Time (US/Canada) Online Event

 

Description

Learn the key phases of an extractables and leachables (E/L) study, including literature gap analysis and efficient study design as mandated by FDA guidelines for drug and biologics packaging. Given the heightened scrutiny of biotechnology drug products, optimizing E/L testing is essential for conserving time and resources.

Join our interactive webinar for a comprehensive E/L study overview, explore valuable literature sources for preliminary insights, and discover how to bridge gaps in information to streamline your study design. We'll delve into E/L study procedures, data management, and real-world case studies while addressing common sponsor challenges.

Areas Covered in the Session :

  • Understanding the different types of extractable and leachable
  • Why test for Extractables Leachables
  • Challenges presented by E/L studies
  • Sources of E/L information and how to leverage them
  • Testing for Extractables
  • Testing for Leachables
  • Interpretation of the E/L data

Who Should Attend:

  • Quality Assurance Departments
  • Quality Control Departments
  • Research and Development Departments
  • Regulatory Affairs Departments
  • Manufacturing Departments
  • Engineering Departments
  • Operations Departments
  • Production Departments
  • Product Development Teams (Formulation and Analytical)
  • Marketing Departments
  • Documentation Departments
  • Supply Chain Departments

Course Director: KELLY THOMAS

Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.

Utilizing strategic thinking, risk based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.