MasterControl

Articles

Lessons Learned from Inspections and Audits During COVID19

Quality Management Software Buyer's Guide

The New Pharma Imperative Quality Flexibility

Connecting Quality Data to Overcome Pharma’s 3 Toughest Challenges

Companies looking to implement a quality management system (QMS) are faced with a dilemma: They can design a custom system from scratch or invest in purpose-built software. Before you decide which kind of QMS is the best fit for your needs, learn the pros and cons of each.

Making the right QMS Choice?

The one lesson the U.S. Food and Drug Administration (FDA) wants us to learn about remote inspections is this — they don’t exist. In press releases and presentations, FDA officials have been very clear that there is no such thing as a remote inspection. There are, however, remote records reviews, remote regulatory assessments, and remote interactive evaluations. The FDA’s remote inspectional activities may be done in advance of or in lieu of inspections, but they are not considered a replacement.

The FDA’s hesitance to make their inspections entirely virtual is understandable and expected. The private sector has no such reservations, and many customer and supplier audits have gone completely remote. Cloud technology enables easy document sharing, virtual tours can be conducted with a mobile device, and auditors can speak with subject matter experts (SMEs) remotely. Being forced to go remote proved that certain audit/inspection activities can just as effectively completed online, as in person.

In this session, MasterControl Senior Product Managers Nate Henriod and Peter Harris explain how a digital quality management system (QMS) improves outcomes in audits. They’ll show a brief demo of the document management aspects of MasterControl Quality Excellence and describe the differences between audits with and without this technology.

The challenges of remote audits/inspections and how digitizing solves them.

The benefits of remote oversight and what’s likely to continue post COVID-19.

How the FDA is approaching remote inspectional activities differently depending on the industry.

Director of Quality, Quality Managers, VP Quality


Nate Henriod has over 20 years of experience in the biologics and medical device fields including orthopedics, vascular access, wound care, and burn treatment with a focus in product development. He has extensive experience with engineering and quality management system (QMS) software. In his current role as Senior Product Manager at MasterControl he works with beta customers to build the Advanced Quality Event Management (QEM) product. Nate has a degree in chemistry from the University of Utah.

Peter Harris has over seven years of experience developing products in the medical device industry. Additionally, he has worked for 12 years creating cutting-edge software products for the health care, medical device, eCommerce, and blockchain industries. His current role as Senior Product Manager is focused on creating a delightful communication platform in MasterControl that enables its users to have total awareness and control over their processes as they happen.

Peter has degrees in molecular biology and Korean, from Utah State University.

Webcasts

Wednesday, March 16, 2022 at 11 am EST | 10am CST | 8am PST
What will audits and inspections look like once COVID 19 has passed? Attend this webinar to learn how the FDA is approaching inspectional activities depending on the industry. 