Eliminate the Confusion – Analytical Method Qualification and Validation

Why Should You Attend:

Execution of a method validation is a resource intensive activity, both in terms of manpower, equipment usage, time, and money. The more the process is well defined and understood, the greater the potential for an efficient project. The less the process and its elements are understood, the greater the chance for delays and additional resource expenditures. There is confusion and a lack of guidance over what constitutes a method qualification compared to a method validation, and what are the requirements for different phases of validation, what is needed at each product phase (I,III,commercial), and what to do when there are failures within a validation. Inclusion of a CRO as an additional factor in this plan potentially escalates areas that need resolution-differences in quality systems, validation requirements, and reports to name a few. Communication without common definitions and understanding of the terms can lead to areas of confusion, project misdirection, and missed timelines.

Areas Covered in the Seminar:

• Definitions of Terms-qualification, validation, verification, co-validation, intended use.
• Standards-Q2R1, FDA Guidelines.
• Requirements for Entry-what is needed in order to start a qualification or validation.
• Requirements for Execution.
• Documentation needs-SOPs, Forms, Worksheets, Data Output, Protocols, Reports.
• Pitfalls and potential resolutions.

Melissa Smith is

• Founder and Principal Consultant at MJQuality Solutions, LLC.
• Formerly Director of Analytical Development, Stryker Biotech, Manager QA/QC Perseptive Biosystems, Manager QC TCell Sciences and Technical Supervisor Biogen QC.
• Senior level professional with over 28 years experience in Quality Control, Quality Assurance, and Analytical Development for Biologicals, Drugs and Devices. Expertise in Assay Development, Validation and Transfer, Auditing (ISO certified, GMP, GLP), and Quality System improvements. Analytical support of Regulatory Submissions.Comparability Assessment for commercial product. Preclinical through Commercial Experience in Device, Drug and Biologics.
• Bachelor Degrees in both Chemistry and Nutritional Science from Syracuse University and Master Degree in Biochemistry from MIT.MBA with major in Computer Systems from Bentley College. Project Management Certificate from Boston University.

For Regsitration:

http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=702314?channel=hummolgen