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John Chapman

co-founder, RAPS chapter

John Chapman, BS, MBA, RAC has over 35 years medical device regulatory & compliance experience and over 15 years experience with the European Union's medical device directive, 93/42/EEC. John has led two device companies to ISO quality system certification and CE marking.

He has been performed regulatory due diligence on over a dozen acquisitions in the past 12 years, exposing him to numerous quality systems, including consent decrees as well as many notified bodies. John has participated in several FDA remediation projects involving non-compliance with all QMS sub-systems. He earned his regulatory affairs certification (RAC) in 1998 and was a contributing author to 2004 Fundamentals of EU Regulatory Affairs, RAPS, 2004. He co-founded a local RAPS chapter and has been a speaker at these meetings and the annual RAPS conference.



  •  Wednesday, March 6, 2019
  • 10:00 AM PST | 01:00 PM EST,
  • 60 Minutes
  • ¤150.00
Verification vs. Validation in Regulated Industries

The meanings and regulatory requirements of the terms "verification"and "validation"are often confusing to engineers and even some regulatory professionals.

  •  Tuesday, March 26, 2019
  • 10:00 AM PDT | 01:00 PM EDT,
  • 60 Minutes
  • ¤150.00
FMEA & Risk Management for Medical Devices

FMEA (Failure Mode Effects Analysis) has long been recognized as a valuable tool in risk assessment and should be considered as an integral part of risk management.

  •  Thursday, April 4, 2019
  • 10:00 AM PDT | 01:00 PM EDT,
  • 60 Minutes
  • ¤150.00
Reprocessing Reusable Medical Devices - Cleaning and Labeling Requirements

This training program will explain the rationale, the legal requirements and some methods commonly used for reprocessing and validating reusable medical devices.

  •  Wednesday, April 24, 2019
  • 10:00 AM PDT | 01:00 PM EDT,
  • 60 Minutes
  • ¤150.00
Failure Modes and Effects Analysis - An effective Risk Management Tool

This Medical device training will acquaint one with the various terms used in risk management and the importance of ISO 14971 & ISO 13485 in the managements of risks during the life cycle of medical devices starting with design and manufacture.





  • Recorded
  • View Anytime
  • ¤190.00
Corrective and Preventive Action

This webinar will define and explain Corrective Action and Preventive Action requirements as found in ISO 13485 and FDA requirements.

  • Recorded
  • View Anytime
  • 60 Minutes
  • ¤190.00
Verification vs. Validation in Regulated Industries

The meanings and regulatory requirements of the terms "verification"and "validation"are often confusing to engineers and even some regulatory professionals.

  • Recorded
  • View Anytime
  • 60 Minutes
  • ¤190.00
FMEA & Risk Management for Medical Devices

FMEA (Failure Mode Effects Analysis) has long been recognized as a valuable tool in risk assessment and should be considered as an integral part of risk management.

  • Recorded
  • View Anytime
  • 60 Minutes
  • ¤190.00
Reprocessing Reusable Medical Devices - Cleaning and Labeling Requirements

This training program will explain the rationale, the legal requirements and some methods commonly used for reprocessing and validating reusable medical devices.