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:
  • Regulatory Affairs
  • Quality Assurance & Control
  • Process Development
  • Auditing & 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

Attendees are encouraged to bring examples of Process Validation issues/concerns that they would like to reviewed and discussed during the course.

Event type:
  • Workshops and courses

Capacity: 20

Eligibility:
  • First come first served

Keywords: Process Validation, product safety, Medical Device, CFR 820, ISO 13485

Medical Device Validation Training for Professionals https://tess.elixir-europe.org/events/medical-device-validation-training-for-professionals-59a3279d-a054-43b1-af46-f7d93e708dc7 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 Attendees are encouraged to bring examples of Process Validation issues/concerns that they would like to reviewed and discussed during the course. 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 Regulatory AffairsQuality Assurance & ControlProcess DevelopmentAuditing & Compliance Engineering 20 workshops_and_courses first_come_first_served Process Validationproduct safetyMedical DeviceCFR 820ISO 13485