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From GlobalCompliancePanel
Lipid Based Formulations and Targeting Tumors - FDA Considerations of Nanotechnology in Drug Manufacturing Drug Delivery and Dru
Overview: Many anticancer drugs are poorly soluble and require higher dosing to achieve some level of delivery to tumors and tumor cells. For chemotherapy the lack of drug and disease specificity and need for higher dosing leads to adverse and serious adverse events that may be dose limiting.
Tuesday, June 12, 2012
10: 00 AM PDT | 01: 00 PM EDT
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Excel Spreadsheets and FDA Device Regulations - Webinar by GlobalCompliancePanel
... * Excel Protection
o Locking and unlocking cells
o Protecting a worksheet
o Protecting a workbook
o Selecting passwords
* Track Changes
o How to turn it on
o The time limit for tracking changes
o Viewing history
* Understanding automated process
o The regulation
+ The concept
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Secrets of an Effective CMC Regulatory Strategy for Biopharmaceuticals Part 1 - Cell Banking - Webinar by GlobalCompliancePanel
... that an adequate supply of equivalent well-characterized cells exist for production over the expected lifetime of the biopharmaceutical.
Cell line development followed by preparation of the master/ working cell banks is an expensive process and needs to be done right the first time. Cell banks acceptable for early clinical trial material production have been found not to be adequate and
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