Bioanalytical Methods Validation


Instructor: Edward O Connor
Product ID: 701769

  • Duration: 60 Min
This training on bio-analytical methods validation will help you to understand the FDA and EMA guidance for Instrumental, ligand binding and cell-based assays and also review of recent 483s impacting validation.
Last Recorded Date: Mar-2013


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Why Should You Attend:

This presentation will examine and discuss recent changes in the FDA and EMA Bioanalytical Method Validation guidance, how they have changed, what features have been omitted but may still be relevant. Cautious guidance in observance of these documents to ensure successful method validation and compliance. For example, there is no description of system suitability, yet this is a given in assuring that the analytical system whether it is instrumental, ligand binding or cell based is performing within acceptance on each day of use before the validation experiment is run.

The attendee will learn what parameters are important and expected for instrumental techniques and what parameters may be applied to ligand binding and cell-based assays. Additionally, the attendee will learn about common pitfalls in method validation and how to reduce the risk and avoid them. This would include ensuring sufficient resources and time to meet validation requirements as well as to examine where quality by design may be implemented.

Areas Covered in the Webinar:

  • Deciding when development is complete
  • Preparation of controls for assay acceptance and stability
  • Matrix Issues
  • Ordering resources, columns, plates, primary and secondary antibodies, complimentary nucleic acids, cell types
  • Rationale selection of interferences, including target enzymes and receptors, and metabolites
  • Selection and implementation of parameters for system suitability
  • Acceptances criteria for runs, stability, recovery and interference
  • Implementing Quality by design during validation runs

Who Will Benefit:

  • Managers and analysts in bioanalytical laboratories
  • QA and QC managers
  • Validation specialists
  • Training departments
  • Study Directors
  • CRAs
  • CRM
  • Sponsors
  • IT support
  • R&D staff
  • Regulatory staff

Free Materials:

  • FDA, EMA Guidance (web sites)
  • Validation Checklist
  • FDA 483 lists and specific 483
  • Industry Best Practices Articles
Instructor Profile:
Edward O'Connor

Edward O'Connor
Individual Consultant, HJJ

Dr. O’Connor has been a Director, Manager and Consultant in regulated Analytical and Bioanalytical laboratories in Pharma, Biotech and CROs for over 25 years. He has had direct involvement in lab relocation and design, method development, method, process and instrument/equipment validation.

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Refund Policy

Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
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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