Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Make Sure Process Validation Is Conducted By 'Qualified' Personnel, Experts Say

This article was originally published in The Gray Sheet

Executive Summary

From our digital archives: Process validation activities must be conducted by “qualified” employees to ensure product quality, experts said. In general, manufacturers must show that individuals who perform process validation are thoroughly familiar with what they are validating, and that they have appropriate credentials. “There definitely is a technical level of confidence that is extremely important” in conducting process validation, Philips Healthcare's Elisabeth George said in September 2011. Further, firms must document that employees and consultants involved in validation meet FDA’s qualification requirement.

You may also be interested in...



Device Week, 4 December 2020 – MedWatch Question About Third-Party Servicers Slides Under Industry's Radar

On this week’s podcast: A change made by the US FDA to its MedWatch program that asks adverse event reporters whether a third party serviced a malfunctioning medical device went unnoticed by many in industry for nearly a year. We explain why, and tell how the servicer question will be helpful for manufacturers and the agency.

SUNSET Draft Rule Is Trump Admin’s ‘Latest Attempt To Sabotage HHS Programs,’ Analyst Charges

The proposed rule from the US HHS that would require its agencies to review all regulations every 10 years could distract an incoming Biden administration from the COVID-19 pandemic and will “wreak havoc” on Medicare, a senior policy analyst for the Center on Budget and Policy Priorities says.

FDA Will Fire Off Noncompliance Letters To Firms That Don’t Report Device Shortages, Agency Warns

The US agency says in the latest update to its medical device shortages guidance doc that it’ll send enforcement missives to companies that don’t notify the agency of a “permanent discontinuance or an interruption in manufacturing” of products deemed critical during the COVID-19 pandemic.

Topics

UsernamePublicRestriction

Register

ID1132679

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel