Introduction to Biotechnology Analytical Methods
Monday, February 11, 2013 from 10:00 AM to 11:15 AM (PST)
Palo Alto, CA
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).
Why Should You Attend:
You should attend this webinar if:
- You are a full-time compliance and quality auditor
- you may be called upon to assist one or a team of auditors going into your own company’s or a contracted quality control lab for biotechnology analyses
- you may be called upon to perform a department self-inspection
- you may be a member of the biotechnology/biochemistry analytical laboratory supervision or management who will host future audits and regulatory inspections
This webinar will show how GMP compliance and good science intersect in this critical laboratory supporting biotechnology API and the resulting, finished pharmaceutical manufacturing. This session will shed light on the evidence normally requested during audits and inspections of biotechnology analytical labs. You will learn how an FDA auditor/inspector thinks and use that knowledge to help your microbiology laboratory and its equipment, documents, records, personnel, etc. become audit-friendly.
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.
When & Where
At ComplianceOnline, we are focused on :
- Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.
- Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.
- Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.
- Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.