Lessons Learned from Inspections and Audits During COVID-19

Register free: https://www.pharmtech.com/pt_w/audits

Event Overview:

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.

Key Learning Objectives:

• 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.

Who Should Attend:

• Director of Quality, Quality Managers, VP Quality
  

Speakers

Nate Henriod
Sr. Product Manager
MasterControl

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.

Pete Harris
Sr. Product Manager
MasterControl

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.

Register free: https://www.pharmtech.com/pt_w/audits