HPLC Method Development and Validation


Instructor: Edward O Connor
Product ID: 702269

  • Duration: 60 Min
This webinar on HPLC Method Development and Validation will outline similarities and differences in validations, and regulatory requirements, outline approaches specific to HPLC and to the various hyphenated detections systems.
Last Recorded Date: Mar-2012


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Read Frequently Asked Questions

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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Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).




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