Designing Effective and Efficient Extractables or Leachables Studies Course: Literature Gap Analysis and Efficient Study Design as Mandated by FDA Guidelines (ON-DEMAND)
Dublin, June 27, 2024 (GLOBE NEWSWIRE) -- The "Designing Effective and Efficient Extractables or Leachables Studies" training has been added to ResearchAndMarkets.com's offering.
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.
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
Key Topics Covered:
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
Speakers
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.
For more information about this training visit https://www.researchandmarkets.com/r/27wwuy
About ResearchAndMarkets.com
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