The Center for Professional Innovation & Education, Malvern, PA
11/10/08
Who Should Attend
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.
Course Description
This course provides comprehensive and up-to-date knowledge of assay validation for quality assurance and control of pharmaceuticals, biopharmaceuticals, and biologics. The course covers regulatory expectations regarding validation as contained in U.S. and International regulations and guidelines. The guidelines of the International Conference on Harmonisation (ICH) will receive special attention and coverage. This course will prepare attendees to plan and execute effective and compliant method validation plans. There will be an opportunity to apply what you have learned in a validation workshop.
In addition, there will be ample time to address specific problems and questions of individual participants. Additional benefits of this class include:- All participants receive a Resource CD with: a Reference List, 483s, Key Guidance Documents, and more
- Learn not just from the director, but tap into the knowledge of your peers: Participants will have the opportunity to anonymously submit their top method validation challenges, problems, and issues for classroom discussion
- Participants will also have the opportunity for one-on-one consulting with the course director during course breaks and in the evenings. The course director has over 15 years of industry experience, over 8 years of consulting experience, and over 10 years of experience directing training courses
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