HPLC Method Development and Validation

Hyphenated HPLC Methods are a major approach to bioanalytical sample analysis, supporting GLP, GMp and GCP studies. HPLC-MS/MS is perhaps the most popular of the hyphenated methods, but –UV, EC, FL, CL, CI and LSD are also represented especially where MS/MS is not the first choice (e.g., sugars). Each detection system has specific requirements that must be addressed.

This course will outline similarities and differences in validations, and regulatory requirements, outline approaches specific to HPLC and to the various hyphenated detections systems. In addition to specific requirements, this course will also present interpretations of recent EMEA, ICH and FDA guidances and industry white papers as they apply to method development and validation. A check list on prerequisites, IQ/OQ/PQ that must be in place before initiating validation will be discussed in detail. Activities such as system suitability, curve editing, QC review and sample acceptance, rejection and re-analysis as well as incurred sample re-analysis will be discussed. Examples of required logs, e.g., column receipt, installation, storage and re-use will be presented.

Learning objectives:

• Learning about the role and responsibilities of an efficient well rounded CRC
• Getting an in depth look at the field of Clinical Research

Areas Covered in the Seminar:

• GMP, GCP and GLP Guidances
• AAPS Journal white papers
• Tips on cross validation to a second instrument ( same type)
• Tips on cross validation to a second instrument different platform
• Role of the Principal Investigator
• Importance of the Master Validation Plan
• Traceability of assay components

Who Will Benefit:

This webinar will provide guidance and assistance to all personnel associated with Bioanalytical Services in a GLP regulated environment.

• Method Development
• Method transfer/ Installation
• Method Validation
• New Principal Investigators/ Scientists
• IN lIfe Study Directors
• Regulatory Compliance Associates and QA Managers

Instructor Profile:

Edward O’Connor, PhD, is a consultant supporting Bioanalytical method development, validation and application to non clinical and clinical sample analysis. His background includes directing these efforts at a number of CROs including Tandem Labs, TherImmune, Covance, Oread and Mason Research. In addition, Dr. O’Connor directed, or managed validation efforts and samples analysis at Elusys, Biogen and MedImmune.

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