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Webinar(s)
WEBINAR 1: Paperless ManufacturingWEBINAR 2: Design ControlsWEBINAR 3: Document ControlsWEBINAR 4: CAPA
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Webinar on Paperless Manufacturing for Medical Device Manufacturers.

Topics for Discussion within this webinar include:

  • FDA Non-Compliance Quality Subsystem Observations.
  • Outcomes for failing to comply.
  • 10 x Rule for Defects in a Manufacturing Process.
  • How CAMSTAR MES fits into the FDA Case for Quality Model.
  • Why 8/10 top medical device manufacturers use CAMSTAR.
  • An FDA presented case for Paperless Manufacturing- electronic systems supporting quality.

Webinar on Design Controls for Medical Device Manufacturers

webinar series

Topics for discussion during this Webinar will include:

  • System Capability Maturity Model
  • Design Control Standards
  • The importance of getting it right first time
  • Managing the design process
  • Digitalise compliance
  • Increased collaboration
  • Reducing time to market

Webinar on Document Controls for Medical Device Manufacturers

Topics for discussion during this Webinar will include:

  • The FDA Case For Quality (CfQ)
  • Document Controls Common Challenges
  • Document Controls – The Regulations (Ireland, UK, EU & USA)
  • 7 Subsystems of Quality System
  • Document Controls – FDA Scope & Non-Compliance Issues
  • Design Controls – FDA Warning Letter Example
  • Outcomes from failing to comply

Webinar on CAPA for Medical Device Manufacturer

Topics for Discussion within this webinar include:

  • The FDA Case For Quality (CfQ)
  • CAPA Common Challenges
  • Regulatory Challenges
  • CAPA Controls – FDA Scope & Non-Compliance Issues
  • CAPA Regulators & Regulations
  • Outcomes for failing to comply