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.
Who Will Benefit:
This webinar will provide auditing tools as well as useful compliance knowledge and ideas for continual improvement to the following individuals inside and outside the life sciences industries:- Compliance and/or Quality Auditors
- Quality Control Microbiology Analysts, Supervisors, Managers, Directors
- Quality Assurance and Compliance Management
- Consultants
- Regulatory Inspectors/Investigators
Course Provider
Robert D Seltzer,
