Organizer: The Center for Professional Innovation & Education

Start: Wednesday, 18 October 2017 @ 09:00

End: Friday, 20 October 2017 @ 15:00

Timezone: Central European Time Zone

Sponsors: The Center for Professional Innovation & Education

Contact: info@cfpie.com

Venue: The Berlin Hilton

City: Berlin

Country: Germany

Target audience:
  • Medical Device
  • Regulatory Affairs
  • Quality Assurance & Control
  • Compliance Engineering
Description:

Participants will learn how an effective Process Validation system is a critical requirement to the movement toward a risk-based approach to compliance and product safety. Also to be discussed is how to tackle process validation for medical device combination products.

Issues to be covered include:
•Learn how poor validation procedures and practices can lead to regulatory actions from regulators
•Assurance of product quality derived from a compliant validation program
•Learn how to improve process system knowledge and understanding
•Learn methods for developing process validations and best practices
•Understand the scope of regulations governing process validation and identify gaps
•Develop a plan to rectify existing validation plans, protocols and reports
•Learn how to implement and deploy a master validation plan

Event type:
  • Workshops and courses

Capacity: 20

Keywords: Process Validation, Risk, validation plans, combination products, Medical Device

Medical Device Validation Training for Professionals https://tess.elixir-europe.org/events/medical-device-validation-training-for-professionals Participants will learn how an effective Process Validation system is a critical requirement to the movement toward a risk-based approach to compliance and product safety. Also to be discussed is how to tackle process validation for medical device combination products. Issues to be covered include: •Learn how poor validation procedures and practices can lead to regulatory actions from regulators •Assurance of product quality derived from a compliant validation program •Learn how to improve process system knowledge and understanding •Learn methods for developing process validations and best practices •Understand the scope of regulations governing process validation and identify gaps •Develop a plan to rectify existing validation plans, protocols and reports •Learn how to implement and deploy a master validation plan 2017-10-18 09:00:00 UTC 2017-10-20 15:00:00 UTC The Center for Professional Innovation & Education The Berlin Hilton, Berlin, Germany The Berlin Hilton Berlin Germany [] info@cfpie.com The Center for Professional Innovation & Education Medical DeviceRegulatory AffairsQuality Assurance & ControlCompliance Engineering 20 workshops_and_courses [] Process ValidationRiskvalidation planscombination productsMedical Device