Thursday April 18, 2019
12:00 pm – 1:30 pm EDT
Measurements within the R&D and Quality Control Laboratories often create issues with those involved — whether it be the technician, supervisor or laboratory manager. These measurement issues may be extremely simple or very difficult to discern based on the newness of the assay, its complexity, the training of the personnel, etc. The FDA will often comment on a Client’s difficulty to follow/interpret an assay — whether it be a USP/EP/JP assay or one developed by the Client.
The assays may vary based on the compendial method being followed, e.g., USP, EP, or JP or, because no method exists. Often the development of new technologies also require the development of new assays or comparable assays that achieve levels of precision, accuracy and quantitation (see USP 1223, 1225) that have not been previously achieved.
Warning Letters will be presented to document some of the various testing issues that the FDA has discovered during recent audits and include recommendations where possible.
The objective of this live, interactive Executive Conference Corp. training webinar will be to explore selected “Uncertainties” within the microbiological and chemistry arena related to FDA compliance, to offer various solutions to assist your organization with FDA compliance initiatives and to provide your organization guidance to maintain itself within a cGMP compliance framework. Involve a cross-sectional group of attendees to gain the most from this webinar.
Learning Benefits will include:
- Examination of Selected Chemistry and Microbiological Inconsistencies Observed within the R&D and Quality Control Laboratories.
- Issues Associated with using Compendial Methods to obtain consistency within Assays.
- Dealing with Uncertainty within Non-Compendial Assays.
- Management of Non-Compendial Assays.
- How your Incoming Raw Material Vendors may create additional Uncertainty in your Assay Testing.
- Product Acceptance Criteria and its Impact Upon Uncertainty.
- How Validation Criteria impact Accuracy, Precision, Linearity and Range.
- How to become aware of Uncertainty in an assay.
- What can be done to eliminate Uncertainty.
- How to work with your vendors to eliminate Uncertainty.
- How to explain “built-in” Uncertainty to your co-workers.
- How significant figures can be used to pass or fail an assay.
- Why chemists have such difficulty understanding microbiological quantitation.
- Review of FDA Warning Letters that incorporate Uncertainty.
Those Who May Benefit Will Include:
- Quality Assurance
- Microbiology
- Quality Control
- Validation
- Metrology
Fee:
$385 for one person
$700 2-5 people
$999 6-10 people
Questions? support@eccwebinars.com
ECC-103