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Seminars

Statistical Elements of Implementing ICH Quality Guidelines
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Statistical Elements of Implementing ICH Quality Guidelines

  • Elaine Eisenbeisz,
  • Virtual Seminar | Dec 7-8, 2023
Reduce costs for compliance with data integrity: 21 CFR Part 11, SaaS/Cloud, EU GDPR
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Reduce costs for compliance with data integrity: 21 CFR Part 11, SaaS/Cloud, EU GDPR

  • David Nettleton
  • Virtual Seminar | January 24-25, 2024
21 CFR Part 11 Compliance for SaaS/Cloud Applications
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21 CFR Part 11 Compliance for SaaS/Cloud Applications

  • David Nettleton
  • Virtual Seminar | January 24-25, 2024
Analytical Instrument Qualification and Computer System Validation
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Analytical Instrument Qualification and Computer System Validation

  • Mark Powell
  • San Francisco, CA | February 5-6, 2024
Managing Domestic and Foreign FDA Inspections and the COVID-19 Impact
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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
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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
Navigating through Maze of In-vitro Diagnostics (IVD) Regulations: A systematic approach from Regulatory Strategy to Regulatory Approvals in U.S./Europe/Canada
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Navigating through Maze of In-vitro Diagnostics (IVD) Regulations: A systematic approach from Regulatory Strategy to Regulatory Approvals in U.S./Europe/Canada

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

  • Mark Powell
  • Simu Live: On-demand Streaming - Virtual Training Through WebEx
Process Validation Guidance Requirements (FDA and EU Annex 15: Qualifications and Validation)
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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
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Supplier and Contract Manufacturer Management for Medical Device Manufacturers

  • Susanne Manz
  • Simu Live: On-demand Streaming - Virtual Training Through WebEx
Designing and Sustaining New and Existing Product Stability Testing Program
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Designing and Sustaining New and Existing Product Stability Testing Program

  • Charity Ogunsanya
  • Simu Live: On-demand Streaming - Virtual Training Through WebEx
Aseptic Processing in the Manufacture of Biotech and Pharmaceutical Products
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Aseptic Processing in the Manufacture of Biotech and Pharmaceutical Products

  • Barry A. Friedman
  • Simu Live: On-demand Streaming - Virtual Training Through WebEx
Ensuring Compliance with Advertising and Promotional Requirements for Drugs and Medical Devices
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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
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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
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Biocompatibility Testing: What You Need to Know

  • Mike Colvin
  • Simu Live: On-demand Streaming - Virtual Training Through WebEx
Effective Quality Oversight of Pharmaceutical Contract Manufacturing Organizations (CMOs)
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Effective Quality Oversight of Pharmaceutical Contract Manufacturing Organizations (CMOs)

  • Andrew Campbell
  • Simu Live: On-demand Streaming - Virtual Training Through WebEx
Building a Vendor Qualification Program for FDA Regulated Industries
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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
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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
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Verification and Validation - Product, Equipment/Process, Software and QMS

  • John E Lincoln
  • Simu Live: On-demand Streaming - Virtual Training Through WebEx
Medical Devices - Post Market Surveillance: Product Complaints Management, Medical Device Reporting, Vigilance Reporting, Product Recalls
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Medical Devices - Post Market Surveillance: Product Complaints Management, Medical Device Reporting, Vigilance Reporting, Product Recalls

  • Dr. h.c. Frank Stein
  • Simu Live: On-demand Streaming - Virtual Training Through WebEx
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