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Validity : 30th Apr'24 to 10th May'24
Conducting GMP Inspections of Laboratories Performing Cell-Based Methods
- Brief overview of FDA and EMEA Guidelines
- Establishing objectives of the audit/inspection
- Identifying the audit team
- Review of quality agreement(s)
- Preparing the audit/inspection plan
- Key systems to review
- Key SOPs to review
- Understanding the impact of differences
- Setting the timing and the agenda
- Communicating findings
- Follow-up and closure of the audit/inspection
Overview of the webinar
Cell-based laboratories are responsible for analytical data for biopharmaceutical products. Included in this analysis are cell-based methods that determine the potency of the product. This webinar will discuss key points to assess during the preparation and performance of GMP laboratory inspections/audits. Included in this presentation are suggestions for specific items to review and negotiating changes to procedures. The quality or laboratory professional who attends this webinar will gain knowledge useful in addressing maintaining a quality method in a cell-based laboratory.
Who should attend?
- Quality Assurance Specialists and Managers
- Quality Control Scientists and Managers
- Development and Validation Scientists
- Regulatory Affairs
Why should you attend?
Attendees will receive knowledge on important procedures to assess during the audit/inspection that are specific for cell-based laboratories. Key points will be addressed that frequently are left for interpretation by the CRO but should be formally addressed by the customer.
Faculty - Dr.Gwen Wise-Blackman
Gwen Wise-Blackman has 20 years of combined experience in Cell-Based Assays and Quality Systems. She has worked at DuPont Pharmaceuticals, Catalent Pharma Solutions (formerly Magellan Laboratories and Cardinal Health), Covance, and Salix Pharmaceuticals. Her focus has been in High-Throughput Screening, Cell-Based Assay Method Development and Validation, and Quality Assurance. Gwen has a Bachelor of Science degree in biology from M.I.T and a PhD in Pharmacology from UVa. She is a member of ASQ and AAPS.