Performing GMP Inspections of Laboratories Performing Cell-Based Methods
Location: Attend Live Webinar
Dates: 28-Oct-2016: 1:00 PM EDT
Duration: 90 Mins
Speaker: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.
Course Description:
Cell-based laboratories are responsible for analytical data for bio-pharmaceutical 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.
Course Objective:
Regulatory Agency Expectations
Identifying Additional Audit/Inspection Topics Specific for Cell-Based Laboratories
Establishing and communicating the audit plan
Identifying potential quality issues
Presenting findings
Negotiating responses
Course Outline:
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
Target Audience:
This webinar will provide valuable assistance to
Quality Assurance Specialists and Managers
Quality Control Scientists and Managers
Development and Validation Scientists
Regulatory Affairs Personnel
Please Click here to Enroll & for more details
Regards,
Joshua
Training Manager
Email: [email protected]
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