Conducting GMP Inspections of Laboratories Performing Cell-Based Methods

Duration: 90 Minutes
Cell-based laboratories are responsible for analytical data of 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 negotiate changes to procedures. The quality or laboratory professional who attends this webinar will gain knowledge useful in addressing and maintaining a quality method in a cell-based laboratory.
GMP Audits
Product ID: 501180
Objectives of the Presentation
  • 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
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.

Areas Covered
  • 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
Who can Benefit
  • Quality Assurance Specialists and Managers
  • Quality Control Scientists and Managers
  • Development and Validation Scientists
  • Regulatory Affairs
  • GMP
  • GLP
Topic Background
Laboratories that perform cell-based methods must meet stringent GMP guidelines for analytical procedures. In addition, standard operating procedures that specifically address working with cells should be in place to maintain control of a live assay system. GMP inspections should cover additional topics in cell-based laboratories to confirm procedures are sound from a regulatory perspective.
$375
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  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
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  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Gwendolyn Wise-Blackman is a successful scientist/manager with increasing accountability for scientific expertise and budget in the pharmaceutical industry, including managing multiple projects. She has working knowledge of FDA/ICH GLP and GMP guidelines and has proven experience with cell-based potency assays, Cell-based neutralization assays, PK and immunogenicity ELISA used to support bioprocess techniques for large molecule therapeutics. Ms. Wise-Blackman also holds Research & Development expertise in High Throughput Screening, 7-transmembrane receptor binding assays, cell-based assays, cell culture, and ELISA. Ms. Wise-Blackman is gifted with excellent presentation skills as evidenced by numerous scientific speaking engagements and working knowledge of PMP principles. She was an invited lecturer for IBC and IVT conferences, 1999-2008.
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