Bioanalytcial sample re-analysis, ISR and analytical re-analysis
Sample re-Analysis for Assay/ Sample failure and Incurred Sample Re-Analysis
onthe sources of sample failure and requirements and limitation of re-analysis.
- Impact on efficacy and safety.
- Incorporating sample re-analysis acceptance and rejection criteria into general and method specific SOPs.
- Regulatory guidelines on sample re-analysis and incurred sample re-analysis comparing FDA, ICH, CHMP, EMA documents.
- Risk management strategy.
- Relevant white papers discussing sample re-analysis ( incurred and for failure).
This webinar will provide an overview of the requirements both for failed assays and samples and for incurred sample re-analysis. The factors and considerations for failed samples and for incurred sample re-analysis and their impact on results, assay and report acceptance will be identified. A review and comparison of the relevant regulatory guidance including the Food and Drug Administration (FDA), the International Conference on Harmonization (ICH), and the Committee for Medicinal Products for Human Use (CHMP)/ the European Medicines Agency will be covered.
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.
With a FREE membership you can get one Exclusive Video every 30 days!
With a free memebrship account, you can browse the entire library, buy credits & attend live webinars and read expert posts. Join and explore the coolest complaince platform ever. Feel free to upgrade anytime to view all Exclusive content and get additional benefits for your account.
Do I have to pay to join?
For FREE signups there is no payment required. No Credit Card needed. We also offer EDGE & PRO, paid memberships.
What are the different formats?
There are Live and Recorded, Expert led webinars. Durations vary from 30min to 6hrs. Standards & checklists are in pdf form
What if I am interested in more than one exclusive?
You can upgrade to EDGE memebrship at any time and enjoy unlimited Exclusive viewing. All our memebrships are annual plans.
How many videos can I watch?
As a FREE memebr you get 1 free exclusive video every 30days. You can buy additional videos.
Who are the Experts?
All Experts on our platform are handpicked or referred by other Experts based on years of experience & proven expertise in providing learning & consulting advice.
What if I have questions after watching a video?
We provide first of its kind, Expert on Call service, where you can directly schedule one on one call with the Expert of your choice & discuss.