Speaker Profile


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.

View All



  • Recorded
  • View Anytime
  • ¤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
  • ¤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
  • ¤390.00
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
  • ¤390.00
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.

View All

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