This webinar will highlight the evidence normally requested during audits and inspections of biotechnology analytical labs. You will learn how your laboratory's biotechnology analytical methods can fulfill stated or implied regulatory requirements (the US FDA refers to these as the “C” in CGMPs).
Areas Covered in the Seminar:
- Assays for Total Protein.
- Reverse Phase and Size Exclusion High Performance Liquid Chromatography.
- Ion Exchange High Performance Liquid Chromatography.
- Reducing and Non-Reducing Sodium Dodecyl Sulfate Polyacrylamide - Gel Electrophoresis.
- Peptide Mapping.
- Isoelectric Focusing.
- Matrix-Assisted Laser Desorption Time-of-Flight (MALDITOF) Mass Spectrometry.
- Adventitious Agent Prevention, Clearance, and Testing.
- Mycoplasma Test.
- Alpha-Interferon Antiviral Bioassay.
- DNA Restriction Mapping.
- Enzyme-Linked ImmunoSorbent Assay (ELISA).
- Western Blotting.
- Polymerase Chain Reaction.
Added by complianceonlinecom on October 19, 2012