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If you are interested in speaking or would like to suggest topics to be covered, please contact Nicole Lyscom, Ph. “This conference provides very deep and broad scientific presentations, roundtable discussions, and excellent networking opportunities for scientists, managers/directors, CROs, vendors and consultants.” - Senior Group Leader, Pfizer “The Immunogenicity and Bioassay Summit covers up-to-date research and regulatory advances on all aspects of immunogenicity.It’s a very good meeting for experts and newcomers to the field.” - Senior Director, Head, Bioanalytical and Biomarker Development, Research & Nonclinical Development, Shire “Program and participants first class.” - Associate Director, Novo Nordisk “Great to get regulatory perspectives on challenges and expectations.SAVE THE DATE: CHI’s Immunogenicity and Bioassay Summit 2018 will be held on October 22-25, 2018 at the Westin Alexandria in Washington, DC.We are currently recruiting speakers for the 2018 summit. To secure a sponsorship or exhibit package for 2018, contact Carolyn Benton at [email protected] our website to stay tuned for details on the 2018 event.
Some of the topics to be covered are: validation and requalification; validation reports, protocols, and documentation; product adoption; troubleshooting; process changes and process equivalency; product release methods; and optimization of sterilization process.
For many years software development teams have been using Agile Software Development methods, but Agile is not just for software.
Agile’s Lean Product Development principles also apply to the development of hardware-based products and systems.
Case studies and situation analyses are used throughout the program to help participants analyze potential areas of noncompliance, identify improvements, and evaluate the various methods of managing a design control program.
The content focuses on the how-to's of implementing a program that meets FDA's design control requirements while ensuring a fast and efficient flow of new products.