Skip navigation

Meets the Requirements for Annual GMP Training for Supervisors and Analysts

December 3, 2019
  • Philadelphia, PA

IVT’s One Day Training Course — GMP Oversight in the QC Laboratory — A uniquely tailored course for supervisors, team leaders, data review managers and analysts who want to understand the supervisory role. This intensive full-day course uses real inspection findings, warning letters, 483 and audit findings, to identify Critical Control Points in the laboratory. Through understanding the risks, participants will gain increased awareness of the controls they already have in place and how to monitor these. Analysts, supervisors and team leaders will benefit from the facilitator’s experience to gain perspectives on inspection handling.

Detailed Information on How to Improve Compliance and Reduce Regulatory Inspection Exposure, Including:

  • Laboratory Data Governance / Data Integrity
    • Audit Trail Review
    • Electronic Laboratory Notebooks vs Manual, Paper, Worksheets
    • Review of Results (Notebooks, Worksheets, Instrument Output)
  • Laboratory Oversight
    • Conducting Effective Internal Audits and CAPA
    • Hosting Regulatory Inspections
  • Lifecycle Management of Analytical Methods
    • Method Development
    • Method Qualification / Validation / Verification
    • Continued Methods Verification
  • Review of Regulations and Guidance
  • Qualification of New Hires / Maintaining Team Competency
  • Review of Analytical Instrument Qualification (AIQ)
  • Reference Standards and Materials, Reagents Management
  • Pharmacopeial and Regulatory Update
  • Statistical Process Control (SPC) of Analytics
  • Oversight of Stability Programs
  • ICH Quality Guidances 1–14 — Are You Proficient?
  • Pharma 4.0 Laboratory Vision for 2025

Don’t miss this rare opportunity to hear one of IVT’s top faculty members, give a structured, in-depth review of what an analyst, lab supervisor or team leader needs to do his/her job. Sign up today!

Course Faculty:
Karen Ginsbury BPharm, MSc has more than 30 years of experience in setting up, maintaining and improving GMP compliant quality systems, including working intensely with Quality Control Laboratories. Karen has run her own consultancy company for more than 25 years, steering clients through FDA, EU, Health Canada and other regulatory inspections; helping companies avoid warning letters, by rapid and effective response to 483 findings, performing 100s of audits around the world, almost all including laboratories. As a regular lecturer at IVT and other professional conferences and events, Karen regularly surveys participants to benchmark best practices and share her experience. A highly interactive lecturer, she is always current and interesting.