Medical Device Process Validation: The Need for a State of Art and Holistic Risk-Based Approach (22 April 2021)

Submitted by admin on Thu, 04/29/2021 - 05:39

A virtual training has been conducted by Mr. Tony Low, WG 8 Co-Chair, Director of Quality Assurance, Regulatory Compliance & Human Performance – Commissioning Agents, Inc. (CAI).  With the presence and support of Chair Mr. Ali Al-Dalaan, Vice Chair Ms. Quan Tran and Acting TC Chair Mrs. Salbiah Yaakop, the webinar has attracted 63 participants from the medical device industry of different countries and the response is overwhelming. 

The speaker provided an overview into the various qualification and validations required during manufacturing; its variables that need to be controlled; its interrelationship with medical device risk management and to the concept of risk-based approach quality management systems introduced in ISO 13485:2016; its often overlooked connection with CAPA on product failures, complaints and adverse events; why just IQ, OQ, and PQ does not equate to an adequate qualification and validation program and what constitutes as a high degree of assurance of consistency of processes.

Based on the speaker’s 3 decades of conformity assessment experience, there were touch on mainstream guidance documents on qualifications and validations in medical device and other life sciences sectors; shortfalls in current approach adopted by manufacturers as well as CAB personnel; and the regulatory oversight required to ensure competencies of pertinent stakeholders.