World Conference Calendar

32784 Conferences

Forced Degradation Studies/ Biologics Stability Programs for Biopharmaceuticals

Added by Referral on 2010-08-25

Conference Dates:

Start Date Start Date: 2010-09-17
Last Date Last Day: 2010-09-17

Conference Contact Info:

Contact Person Contact Person: admin
Email Email: admin@complianceonline.com
Address Address: 2600 E. Bayshore Road, Palo Alto, CA, 94303, United States
Phone Tel: 650-620-3915
Phone Fax: 650-963-2556

Conference Description:

This training on Forced Degradation study on a Protein Therapeutic will discuss on the Forced Degradation Studies required for Well Characterized Protein Therapeutic products and how to leverage forced degradation results to design stability studies for Drug substances.

Areas Covered in the Seminar:

- The goal of Forced Deg studies .
- Stress conditions for Forced deg studies.
- Degradants generated by these stress conditions.
- Methods required to study these degradant.
- Leveraging forced deg results to design stability studies.
- Using forced deg results in specification setting.
- Common pitfalls in Biologics Stability Studies.
- Types of deficiency letter comments.

Who Will Benefit:

This course is intended to provide training on how to evaluate compendial methods in order to comply with USP
- R&D Laboratory personnel
- R&D Laboratory Supervisors and Management
- QC Laboratory personnel and management
- Protein Formulation Group personnel and Management
- Regulatory Affairs personnel
- Regulatory Affairs Management
- Project Managers responsible for CMC sections
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