Bioanalytical Sample Re-Analysis, ISR and Analytical Re-Analysis"

Implementing a solid sample re-analysis plan in the bioanalytical lab can help the lab avoid many regulatory issue. This presentation will cover instances where sample re-analysis is required, the responsible parties for initiating samples re-analysis (Bio Lab, PK/PD, and Study Director) and how the information and request for retest are handled. This presentation will also indicate needed SOPs, anticipation of outcomes and their resolution. The presentation will also include a discussion of both incurred sample reanalysis and parallelism.

Course Objective

This training on sample re-analysis will help you understand compliant approaches for sample re-analysis whether using instrumental, ligand binding, and cell based methods. A comparison of EMEA and FDA guidance relating to sample re-analysis will be presented.

Course Outline

FDA regulations and guidelines.
Comparison of FDA, EMA and CLIA (CAP) re-analysis requirements
Learning from the Crystal City FDA/Industry conference report.
Logistics of sample re-analysis
Preparation and use of reference standards and equipment
Defining parameters and acceptance limits
Defining and scheduling re-analysis
Documenting and archiving raw and source data
Implication of re-analysis results on validation

Target Audience

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

Webinar Events

Live -Coming soon!

Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment

$499

Recorded video

Recorded video session

$349

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Speaker: Edward 'O' Connor,

Ed'O'Connor is currently senior consultant for Aegis Bio consulting. He has over 20 years in regulated bioanalysis serving in Director or manager level roles in Biotech at Alexion, Elusys, Biogen and Medimmune and At CROs including Matrix, Tandem, Therimmune and Covance. He has a PhD in Zoology from UMass Amherst and a BS degree from Texas A&M Commerce. His post-doctoral training focused on the neuroendocrine system in health and disease. 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 Biotech's MedImmune, Biogen and Elusys.