ComplianceOnline

Detailed review the QSR and ISO requirements for supplier evaluation and assessment, and cost efficient options to many of the common practices.

This webinar covers production and QMS requirements for software (Excel spreadsheet) built into a medical device, as outlined in 21 CFR 820.70(i).

This 90-minute 510(k) webinar will discuss the recent changes in the 510(k) program and will walk you through how to better format a 510(k) premarket notification submission.

This Medical Device Directive training will discuss the recently implemented and currently planned changes to the Medical Device Directives across the EU.

This Immunogenicity risk training Webinar will help you understand immunogenicity and analyzing risk factors to strategically develop biopharmaceuticals.

This Bioassays webinar will systematically outline the steps needed to successfully transfer validated biological assays between GMP/GLP labs and also acquire non-validated assays for GMP/GLP development.

This 90-minute webinar will provide guidelines for bioassay validation and regulatory documentation, the steps for technology transfer and commercial validation show how to implement the new USP chapters 1032, 1033 and 1034.

The FDA has requested BLA sponsors to submit sub-visible particulate data for Well Characterized Protein Products in the clinical and commercial phases. The evidence continues to accumulate particulates increase immunogenicity of the protein product.

This webinar on Potency Bioassays will show how to implement the parameters described in the new USP Bioassay suite to deliver compliant assays for Phase I/II, Phase III and commercial products.

This CLIA Webinar training will feature an in-depth look at CLIA Waived Testing. It will present the rules and regulations as well as the pros and cons of testing using Waived methods.