Auditing Your QMS During Pandemic Times
By Suneel Kumar Remote auditing (RA) has become the norm during the Covid-19 pandemic and…
Strengthening Standardization More Important Than Ever in Times of Crisis
By Barnaby Lewis The extraordinary events of 2020 may have brought some sectors to…
Keep Calm and Parry On
By Mike Richman I’m not going to sugarcoat it: 2020 has been a real…
Workcred and NGA Publish Brief on Non-Degree Credentials
A recently published brief by Workcred, in partnership with the National Governors Association (NGA), sheds…
Embracing Regulatory Controls Can Help You Map Medtech Innovation
By Christopher Montalbano The complicated process of satisfying FDA requirements gives many medical device developers…
Pharmacovigilance Audits: Keeping on the Right Side of Inspectors
by Vanessa Fachada Oliveira Regulating authorities need to be confident that standards relating to…
Mock FDA Inspections at Medical Device Manufacturers
By Dan Goldstein Most manufacturers of medical devices sold in the United States are…
Four Ways to Get More Value from Your Internal Audits
By Andrew Milner The need for an organization to implement an internal audit program…
How to Increase the Value of Your Supplier Audits
By Angelo Scangas A manufacturer’s ability to maintain high-quality products and regulatory compliance depends largely…
The Importance of Trust: Building an Adaptable Health and Safety Management System
By Michael Brittliff With the processes involved in bringing workers back into pre-COVID workplaces, risk…