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Seminars

In Depth EU Medical Device Regulation (MDR) 2017/745 Training
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In Depth EU Medical Device Regulation (MDR) 2017/745 Training

  • Juan M Campos
  • Virtual Seminar | September 21-24, 2020
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 | September 23-24, 2020
Medical Device Recall Management
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Medical Device Recall Management

  • Susanne Manz
  • Virtual Seminar | September 23, 2020
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 | September 23-24, 2020
Managing Your Complaints and Obstacles in Post-Market Requirements -- Results from Top Medical Device Observations During an Inspection
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Managing Your Complaints and Obstacles in Post-Market Requirements -- Results from Top Medical Device Observations During an Inspection

  • Rita Hoffman
  • Virtual Seminar | September 24-25, 2020
Supplier and Contract Manufacturer Management
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Supplier and Contract Manufacturer Management

  • Peggy Kwoka
  • Virtual Seminar | September 28-29, 2020
HIPAA Privacy Rule Compliance-Understanding New Rules and Responsibilities of Privacy Officer
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HIPAA Privacy Rule Compliance-Understanding New Rules and Responsibilities of Privacy Officer

  • Jim Sheldon-Dean
  • Virtual Seminar | September 30-October 1, 2020
Effective Quality Oversight of Pharmaceutical Contract Manufacturing Organizations (CMOs)
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Effective Quality Oversight of Pharmaceutical Contract Manufacturing Organizations (CMOs)

  • Andrew Campbell
  • Virtual Seminar | October 6-7, 2020
FDA Recalls - Before You Start, and After You Finish
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FDA Recalls - Before You Start, and After You Finish

  • Casper E. Uldriks,
  • Virtual Seminar | October 8-9, 2020
REACH and RoHS Compliance: Gain a Deeper Understanding
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REACH and RoHS Compliance: Gain a Deeper Understanding

  • Kelly Eisenhardt
  • Virtual Seminar | October 8-9, 2020
Lifecycle Management of Analytical Methods and Procedures - according to new FDA and USP guidelines
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Lifecycle Management of Analytical Methods and Procedures - according to new FDA and USP guidelines

  • Mark Powell
  • Virtual Seminar | October 8-9, 2020
Validation, Verification and Transfer of Analytical Methods (Understanding and implementing guidelines from FDA/EMA, USP and ICH)
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Validation, Verification and Transfer of Analytical Methods (Understanding and implementing guidelines from FDA/EMA, USP and ICH)

  • Mark Powell
  • Virtual Seminar | October 19-20, 2020
HIPAA Security and Breach Rule Compliance- Understanding Risk Analysis, Policies and Procedures and Managing Incidents
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HIPAA Security and Breach Rule Compliance- Understanding Risk Analysis, Policies and Procedures and Managing Incidents

  • Jim Sheldon-Dean
  • Virtual Seminar | October 21-22, 2020
The Drug Development Process from Concept to Market
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The Drug Development Process from Concept to Market

  • Mark Powell
  • Virtual Seminar | October 22, 2020
Fundamentals of EU MDR and IVDR – Level 1
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Fundamentals of EU MDR and IVDR – Level 1

  • Kelly Eisenhardt
  • Virtual Seminar | October 22-23, 2020
FDA's Regulation of Regenerative Medicine including Stem Cell Treatments and Tissue Engineering
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FDA's Regulation of Regenerative Medicine including Stem Cell Treatments and Tissue Engineering

  • Theodore Sand,
  • Virtual Seminar | October 22-23, 2020
Laboratory Inspection and Auditing
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Laboratory Inspection and Auditing

  • Mark Powell
  • Virtual Seminar | October 23, 2020
Lead Auditor EN ISO 13485:2016 and EU MDR 2017/745 - Regulation
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Lead Auditor EN ISO 13485:2016 and EU MDR 2017/745 - Regulation

  • Prof. Dr. h.c. Frank Stein
  • Virtual Seminar | October 27-28, 2020
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
  • Virtual Seminar | November 5-6, 2020
Preparing for FDA's New Import/Export Trauma in 2020
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Preparing for FDA's New Import/Export Trauma in 2020

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

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