Seminars

Data Integrity: FDA/EU Requirements and Implementation

  • Mark Powell
  • Virtual Seminar | September 14-15, 2020

FDA Recalls - Before You Start, and After You Finish

  • Casper E. Uldriks,
  • Virtual Seminar | October 8-9, 2020

Preparing for FDA's New Import/Export Trauma in 2020

  • Casper E. Uldriks,
  • Virtual Seminar | November 17-18, 2020

21 CFR Part 11 Compliance for SaaS/Cloud Applications

  • David Nettleton
  • Virtual Seminar | November 18-19, 2020

FDA's Medical Device Software Regulation Strategy

  • Casper (Cap) Uldriks
  • Virtual Seminar | November 19-20, 2020

Social Media Crisis Management

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Risk Management System in Medical Devices Industry

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Statistics for Quality Engineering

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Biocompatibility Testing for Medical Devices

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Good Documentation Practice and Record Keeping Regulations (FDA & EMA)

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

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Managing GMP Compliance and Phase Appropriate GMP Considerations for Virtual Companies

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Equipment and Utilities Qualification

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GxP/GMP and its Consequences for Quality Management, Quality Audit, Documentation, and Information Technology Systems

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