Seminars

21 CFR Part 11 Compliance for SaaS/Cloud Applications

  • David Nettleton
  • Virtual Seminar | August 21-22, 2024

Introduction to Design of Experiments: Methods and Analysis

  • Elaine Eisenbeisz
  • Virtual Seminar | September 26-27, 2024

Managing Domestic and Foreign FDA Inspections and the COVID-19 Impact

  • Casper E. Uldriks
  • Simu Live: On-demand Streaming - Virtual Training Through WebEx

Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment - Issues and Solutions

  • Barry A. Friedman
  • Simu Live: On-demand Streaming - Virtual Training Through WebEx

Laboratory Inspection and Auditing

  • Mark Powell
  • Simu Live: On-demand Streaming - Virtual Training Through WebEx

Analytical Instrument Qualification and Computer System Validation

  • Mark Powell
  • Simu Live: On-demand Streaming - Virtual Training Through WebEx

Technical Writing for Pharma, Biotech and Medical Devices

  • Mark Powell
  • Simu Live: On-demand Streaming - Virtual Training Through WebEx

Process Validation Guidance Requirements (FDA and EU Annex 15: Qualifications and Validation)

  • Barry A. Friedman
  • Simu Live: On-demand Streaming - Virtual Training Through WebEx

Supplier and Contract Manufacturer Management for Medical Device Manufacturers

  • Susanne Manz
  • Simu Live: On-demand Streaming - Virtual Training Through WebEx

Aseptic Processing in the Manufacture of Biotech and Pharmaceutical Products

  • Barry A. Friedman
  • Simu Live: On-demand Streaming - Virtual Training Through WebEx

Designing and Sustaining New and Existing Product Stability Testing Program

  • Charity Ogunsanya
  • Simu Live: On-demand Streaming - Virtual Training Through WebEx

Ensuring Compliance with Advertising and Promotional Requirements for Drugs and Medical Devices

  • Alexander Zachos
  • Simu Live: On-demand Streaming - Virtual Training Through WebEx

Method Development and Validation for Assays Supporting Testing of Biologics

  • Gwen Wise-Blackman
  • Simu Live: On-demand Streaming - Virtual Training Through WebEx

Biocompatibility Testing: What You Need to Know

  • Mike Colvin
  • Simu Live: On-demand Streaming - Virtual Training Through WebEx

Building a Vendor Qualification Program for FDA Regulated Industries

  • Joy McElroy
  • Simu Live: On-demand Streaming - Virtual Training Through WebEx

SOP Writing, Training and Compliance in the Pharmaceutical Industry

  • Michael Esposito
  • Simu Live: On-demand Streaming - Virtual Training Through WebEx

Verification and Validation - Product, Equipment/Process, Software and QMS

  • John E Lincoln
  • Simu Live: On-demand Streaming - Virtual Training Through WebEx
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