Nancy Duarte-Lonnroth
Instructor Nancy Duarte-Lonnroth
Product Id 600221
Duration 60 Minutes  
Version Recorded
Original Price $295
Special Offer Price $10
Refund Policy
Access recorded version only for one participant; unlimited viewing for 6 months

Verification vs. Validation in Regulated Industries

Overview:

This webinar will teach how Design Verification and Validation, Process Validation, Risk Management and Purchasing Controls work together to produce safe medical devices.

Why should you attend: FDA continues to issue Warning Letters to companies that fail to properly complete Design Verification, Design Validation, Process Validation and recently has issues Warning Letters including failures of manufacturers in Risk Management.

This webinar will show how Design Verification, Design Validation, Process Validation, Risk Management and Purchasing Controls work together to produce safe medical devices.

Also discussed are risk management documentation tools used to meet the requirements of the ISO 14971 standard during these final phases of product development. Not only will meet regulatory requirements be a subject of the presentation, but also doing so efficiently.

Areas Covered in the Session:

  • What exactly are FDA and ISO 13485 requirements for Design Verification, Design Validation, and Process Validation?
  • How does Risk Management integrate into these later phases of product development?
  • What Design Output requirement is key to these late design phases and also to meeting requirements of Purchasing Controls?
  • What Design Verification and Design Validation requirements are established in the Risk Management standard?
  • How does Process Validation impact the Design Validation process?
  • How can I efficiently meet documentation requirements of the Risk Management standard during the late design phases?
  • How are suppliers involved in the late design phases?


Who Will Benefit: Attendees should understand the concepts of manufacturing processes from the design or production view. People in the following roles can especially benefit from the knowledge in this webinar:
  • QA managers and personnel
  • Verification and Validation specialists
  • Quality system auditors
  • Process validation specialists
  • Product design managers
  • Regulatory Affairs
  • Risk Managers

Speaker Profile
Nancy, is the Director of Quality & Regulatory Affairs, Healthcare responsible for global coordination of Celestica's Healthcare Quality, Regulatory and FDA compliance. Nancy is Quality and Regulatory expert with fifteen years experience in regulatory affairs, quality systems, compliance, clinical quality, validation, auditing, quality control, data management systems, post market surveillance, supplier management and regulatory compliance in the areas of bio/pharmaceuticals, medical devices and combination products. Nancy has contributed to the success of both venture and public companies, establishing a track record of successfully achieving timely global regulatory approvals, initiating and effectively managing preclinical and clinical investigations and developing and maintaining effective and compliant quality systems in various healthcare sectors.

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