GMP Auditing of Facilities Performing Cell-Based Methods

Duration: 60 Minutes
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.
GMP Laboratory Audits
Product ID: 506592
Objectives of the Presentation
  • Regulatory agency expectations
  • Identifying additional audit/inspection topics specific for cell-based laboratories
  • Establishing and communicating the audit plan
  • Identifying the audit team
  • Assessments during the walk-through
  • Setting the timing
  • Identifying potential quality issues
  • Presenting findings
  • Negotiating responses
Why should you Attend
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 that attends this webinar will gain knowledge useful in addressing maintaining a quality method in a cell-based laboratory.

Areas Covered
  • Brief overview of FDA and ICH Guidelines
  • Establishing objectives of the audit/inspection
  • 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 will Benefit
  • Compliance Professionals
  • Validation Scientists
  • Quality Assurance
  • Quality Control
  • Regulatory Affairs
  • Laboratory Managers
  • Assay Development Specialists
Topic Background
Biologics are a growing industry. The FDA and other regulatory agencies expect quality in all products delivered to the public. Auditing laboratories involved in the testing of biologics is crucial to establishing and maintaining expectations of quality. In this webinar attendees will receive essential information on planning, performing, and following-up on routine or for cause audits of laboratories involved in test methods for biologics. These methods likely require additional quality measures to be in place that auditors must understand to ensure specifications and product quality conforms to requirements. The focus of this webinar is to offer guiding principles that help auditors achieve the goal of confirming quality in the systems and procedures supporting biologics.
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  • Please click on the link to access the Recorded Session
  • 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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