Bioanalytical Methods Validation - Incorporating EMA and FDA Guidance as well as other concerns

Instructor: Edward O Connor
Product ID: 701769
  • Duration: 60 Min

recorded version

1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Mar-2016

Training CD

One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

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Read Frequently Asked Questions

This training on bio-analytical methods validation will help you understand the clear, consistent and compliant approaches for instrumental, ligand binding, and cell based methods. A comparison of EMEA and FDA guidances will be presented.

Why should you Attend:

Bioanalytical method validation includes various procedures that demonstrate that a particular method used for quantitative measurement of analytes in a given biological matrix, such as blood, plasma, serum, or urine, is reliable and reproducible for the intended use. It is essential to employ well-characterized and fully validated bioanalytical methods to yield reliable results which can be satisfactorily interpreted.

This webinar will discuss the best practices of Bioanalytical method validation, including components of a validation, how to include critical reagents comparison, selectivity experiments, assessment of stability. Concept of plate and experiment separation. Importance of communication between the development and the validation labs, accuracy of transfer documents (SOPs). Predicate rules, support of clinical and non clinical sample analysis.

Understand - Is validation a regulated activity? When to pull the trigger for validation? Is a stable label internal standard always the best choice? Importance of suitability testing. Value of including critical reagents testing and suppliers. The limits of an assay and where they come from.

Areas Covered in the Seminar:

  • FDA regulations and guidelines.
  • Learning from the Crystal City FDA/Industry conference report.
    • Phased approach for validation during drug development
    • Logistics of validation
    • Development of a master plan and SOP for validation
    • Preparation and use of reference standards and equipment
    • Defining parameters and acceptance limits
    • Defining validation experiments
    • Documenting and archiving raw and source data
    • Considerations for Microbiological and Ligand-binding Assays
    • Working with QC samples for quantitative results
    • To revalidate or not after method changes
    • Transferring and using the method to routine
    • Using computers for automated method validation
    • Documentation for the FDA and other agencies

Who Will Benefit:

  • Managers and analysts in bioanalytical laboratories
  • Managers and analysts in forensic and toxicological laboratories
  • QA managers and personnel
  • Validation specialists
  • Training departments
  • Documentation department
  • Consultants
  • Bioanalytical scientists
  • Pharmacokinetic specialists
  • Biotech R&D staff
  • Clinical research associates
  • Regulatory staff
  • Outsourcing Professionals
  • Biopharmaceutical Consultants

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 as well as Biotechs MedImmune, Biogen and Elusys.

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Upcoming In-person Seminars by EX-FDA OFFICIALS
Analytical Instrument Qualification and System Validation

Refund Policy

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.

If you have any concern about the content of the webinar and not satisfied 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 call +1-888-717-2436 (Toll Free).

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