Extractables & Leachables West Coast Summit, 2021

Ensuring Quality, Safety, Suitability, & Regulatory Compliance for Drugs, Biologics and Medical Devices

November 11-12, 2021, San Diego, (Hybrid)

Meet Our 2021 Speakers

Ronald Brown
Ronald Brown
Toxicologist (formerly FDA)
Risk Science Consortium
Dennis Jenke
Dennis Jenke
Chief Executive Scientist
Triad Scientific Solutions
Diane Paskiet
Diane Paskiet
Director, Scientific Affairs
West Pharmaceutical Services
Ping Wang
Ping Wang
Director
Johnson & Johnson
Ted Heise
Ted Heise
VP, Regulatory & Clinical Services
Med Institute
Steven Zdravkovic
Steven Zdravkovic
Senior Research Scientist
Baxter
Roger Pearson
Roger Pearson
President, Analytical Services
Aspen Research Coporation
Philippe Verlinde
Philippe Verlinde
Innovation Manager/ Senior Scientist
Nelson Labs NV
Michael Ruberto
Michael Ruberto
Founder & CSO
Material Needs Consulting
Michael Eakins
Michael Eakins
President
Eakins & Associates
James Hathcock
James Hathcock
Senior Director
Pall Biotech
Eric Hill
Eric Hill
Director
Boston Analytical
Dujuan Lu
Dujuan Lu
Manager/Global Lead, E&L
SGS
Jordan Tocher
Jordan Tocher
Senior Scientist
Jordi Labs
Emma Leishman
Emma Leishman
Technical Manager, Advanced Analytics
Element
Sherry Parker
Sherry Parker
Sr. Director
WuXi AppTec
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Extractables & Leachables West Coast Summit, 2021

November 11 November 12

This two-day conference will examine the safety, quality, and regulatory issues involved in a wide array of contexts central to the pharmaceutical and biotech industries, including drug packaging and delivery components, single-use systems, medical devices, and parenteral drug products. In addition, we will focus closely on the keys to satisfying recent revisions to several applicable USP chapters, ICH Q3E, and the recently revised standards contained in ISO 10993.

Why Attend:

  • Two full days of presentations, panel discussions, and networking
  • The industry’s top experts share their knowledge and lessons learned
  • Learn what you need to know to meet FDA expectations for E/Ls in drug products, delivery systems and medical devices
  • Focus on overcoming common analytical challenges in E/L study design
  • Gain insight into AET’s and uncertainty factors in E/L analysis

PHARMA ED’S EXTRACTABLES & LEACHABLES SUMMIT FEATURES IN-DEPTH COVERAGE ON

  • Update on ICH Q3E Guideline for Assessment & Control of Extractables & Leachables
  • Designing and Improving Risk-Based Assessment of E&L Data for Drugs, Biologics, and Medical Devices
  • Implementing ISO 10993-17 & ISO 10993-18 Standards
  • AETs and Response Factor Variation for E/L Studies
  • Meeting Regulatory Expectations for E&Ls in Drug Products, Delivery Systems, and Medical Devices
  • Regulatory Strategies in the Age of Covid-19: Lessons Learned
  • Chemical Characterization in Biocompatibility for Med Devices
  • E&L Considerations in the Qualification and Validation of Single-Use Systems
  • Addressing E&Ls from Bioprocessing Equipment & Product Packaging Perspectives
  • And Much More!

GOLD SPONSOR

PHARMA ED’S EXTRACTABLES & LEACHABLES SUMMIT 2021 SPONSORED BY

EKG Labs
JordiLabs
Element
Smithers
SGS
Boston Analytical
VR Analytical
ARL
Aspen Reasearch
Ondrug Delivery
Drug Development
Material Needs Consulting
Triad

About This Year’s Extractables & Leachables West Coast Summit: Health & Safety First

Driven by breakthroughs in vaccine development and emerging new therapies, the country is inching closer to a new normal. While the situation remains fluid and there is still much work to be done, we are optimistic that we will be able to meet in-person safely later this year.

We are planning Extractables & Leachables West to be an in-person/hybrid event, enabled by the increased availability of vaccination, the expected decrease in COVID transmissibility, and our ongoing implementation of public health and safety measures. The health and safety of our attendees, sponsors and speakers remains our top priority, and we will endeavor to locate a venue that can ensure the well-being of all. Extractables & Leachables West will also be live-streamed–the hybrid part–so that anyone who may wish to participate virtually will have the option to do so.

Illinois USA

2810 Robeson Park Drive
Champaign, IL 61822 United States
+ Google Map
217.721.5774
View Venue Website

PharmaED Resources

217.721.5774

View Organizer Website