Institute for International Research

Course Description

This course provides the attendee with a comprehensive discussion of the principles and procedures that are part of a modern Analytical Quality Control Strategy for biologicals. The course will be based on the ICH Q2 (R1) guidelines, which will be described in detail, experimentally and fundamentally. As a result, the content of this course will serve as a roadmap to developing and validating key purity methods in a biological quality control system. This shall include detailing the purpose of the method, key parameters to consider for optimization and robustness as well as detailed descriptions of the validation activities (including cGMP documentation needs, such as pre-approved protocols and reports).

However, contrary to common belief, the job of the technical expert does not end here, but we must also take into account method training, transfer and monitoring. The course will include detailed examples on how to write a clear and concise test procedure for routine use. Many good methods fail in routine testing due to inadequate procedures and poor training. We will dedicate time to discuss training as well as transfer activities.

And finally when speaking of transfer activities in today's biotechnology world, we now also face many interactions with contract manufacturers, both for development and release or purely release. Guidance will be given on how to make the most out of your interactions with a contract site.

During the course, we will focus on the technical knowledge, while emphasizing the purpose and terminology to ensure that the attendee will not only be able to reproduce the experiments detailed out, but also explain them as needed.

Who Should Attend?

This course is developed for managers, scientists, supervisors and associates working in the following areas:

• Characterization
• Regulatory Affairs
• Development
• Research
• Quality Control
• Validation

Complete Course Agenda

Course Instructor

Chantal Felten, Ph.D., Industry Consultant
Dr Chantal Felten has over seven years of experience leading Genentech's method validation function. During her time at Genentech, Dr Felten lead the Early Stage (Phase I/II) as well as the Late Stage (Phase III to post commercial) validation functions. In addition, she managed the commercial method transfer and troubleshooting function and oversaw clinical and commercial PCR activities. Her background covers both HPLC and CE, with a joint Ph.D. from Prof. Heinz Engelhardt and Prof. Barry Karger, both of whom are credited with many advancements in the field of instrumental analytics. Prior to joining GNE, Dr Felten was a visiting scientist at Prof. Barry Karger's laboratory in Boston, MA working on proteomics through coupling of Capillary Electrophoresis to Mass Spectrometry.

Dr Felten has personally validated several key methods that are now a part of GNE's commercial control systems. As a group leader/senior scientist, she had technical oversight over countless method developments/validations for commercial and clinical filings, with over 30 successful IND/BLA filings.

Dr Felten is now working independently as a consultant and as such is consulting to GNE for Phase appropriate GMP, including approaches to validation for early stage clinical.

She has been actively lecturing and teaching on the principles of method validation over the years, with organizations such as Beckman Industries, CE in Pharmaceuticals and of course IBC.