Date: 14th - 15th July, 2008

Location: Costa Mesa, CA, USA

Summary:
Pharmaceutical - Training

This two-day course is designed for those who perform, supervise, manage, audit, or oversee the validation of analytical methods for the quality control of small molecule pharmaceuticals, biopharmaceuticals, and biologics. This includes, but is not limited to, professionals in Analytical Development, Quality Control, Quality Assurance, and Validation groups. The course will also benefit those in other departments who find method validation among their responsibilities.

Learning Objectives
Upon completion of this course, attendees will have a clear understanding of regulatory agency expectations and will have gained the background knowledge necessary to effectively plan assay validation programs. Participants will develop expertise in writing protocols and reports and in setting acceptance limits for assay validation. Participants will have acquired insight into how to avoid common validation pitfalls and be able to quickly discriminate compliant from non-compliant validation activities. In addition, attendees will gain practical experience in applying what they have learned during a validation workshop.