Quality Assurance and Quality Control of Biologics and Vaccines
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:By the end of this workshop, participants should be able to
1- Identify the differences between chemical drugs and biologics as well as differences between reference biologics and biosimilars that impact QC/QA.
2- Differentiate different responsibilities assigned to QC and QA teams in the pharmaceutical industry.
3- Recall essential published QC/QA guidelines from different regulatory arms.
4- Judge where in a biological manufacturing process should QA/QC be present.
5- Judge when during clinical development should QA/QC be present.
6- Identify the different sources of contamination and the different QC/QA measures taken to minimize the risk.
7- Identify the general types of potency tests used for QC/QA across the biotech industry and understand how potency testing requirements vary across the different clinical stages.
8- Identify the different types and sources of impurities and appreciate the different QC/QA measures taken to minimize its risk.
9- Appreciate challenges related to structural characterization of biologics as well as identify general principles for consideration in setting specifications for QC/QA appropriate testing.