March 26, 2021
By Paula Pilecki, Sr. Director of Project and Audit Management, MWA Consulting, Inc.
The COVID-19 pandemic created unprecedented challenges for quality and compliance professionals in the pharmaceutical, biotech, and medical device industries. Staying on course toward product approval and audit schedules is dependent on maintaining a robust compliance roadmap, which includes sponsoring GxP audits.
February 23, 2021
By Nicolle Cannon, Founder/CEO, Cannon Quality Group
Last year brough a lot of changes to audits. In addition to remote audits, MedTech suppliers are learning the value of shared audit to be beneficial in working down the backlog of audit requests while reducing exposure in the plant.
October 23, 2020
By David Jensen, Staff Writer, Master Control
Regulated companies are settling into the reality of COVID-19. New operational paradigms present challenges to hosting audits. See how technology has made it more feasible to conduct various types of audits remotely.
October 16, 2020
By David Butcher, Staff Writer, MasterControl
For manufacturers, supplier auditing is essential to gaining visibility into whether a supplier’s products and processes are adhering to a defined quality standard. According to Terrance Holbrook, MasterControl’s director of product, there are five often-overlooked actions that manufacturers can take to improve how they conduct supplier audits.
October 5, 2020
By David Butcher, Staff Writer, MasterControl
A bill of materials (BOM) is crucial for ensuring a complete and accurate view of product parts and for protecting and analyzing the use of resources throughout the life cycle of a product. Any revision to a product’s design must be updated in the BOM, accurately identifying and listing what is required to produce the product. Because it extends to a variety of departments, BOM management often results in a number of common challenges for manufacturers.
September 4, 2020
By Jason Clegg, Director, Marketing Strategy
Audits are essential to regulated industries. The type of audit, who conducts it, and which regulations and standards are involved are all important. The process has its own challenges which have only been exacerbated in the current environment.
Supplier audits are the standardized testing of the manufacturing world. Suppliers and manufacturers are held to high quality standards and both must adhere to them to ensure final products are safe and effective. The key to this is a thorough supplier audit in which the supplier and manufacturer work together to improve quality throughout the supply chain.
July 2, 2020
By David Jensen Staff Writer, MasterControl
The COVID-19 pandemic disrupted many aspects of global societies, lifestyles and economies. Fortunately, technology has enabled the regulatory industry to continue functioning by conducting audits remotely. In this article, Derek Churchill, senior consultant at Quality Support Group (QSG), explains how remote audits work and how companies can prepare for this new type of audit.
April 9, 2020
by Angelo Scangas, President and CEO, Quality Support Group (QSG)
A manufacturer’s ability to maintain high-quality products and regulatory compliance depends largely on its suppliers’ own quality-related activities. Leveraged correctly, supplier audits can be an important tool that gives manufacturers greater visibility into these activities, according to Quality Support Group CEO Angelo Scangas.
December 17, 2019
by Sarah Beale, Staff Writer, MasterControl
It’s the time of year for parents to pull out the Elf on the Shelf and regale their children with stories of how their behavior gets reported back to Santa. Making sure those reports are accurate depends on whether the elf is using paper or digital solutions.
November 19, 2019
by David Jensen, Staff Writer, MasterControl
Over the years, Charlie Brown and the Peanuts gang have regaled us with TV specials featuring their own brand of holiday celebrations. One show that never made it to the airwaves was the gang’s experience operating a medical device manufacturing plant that was having an audit. This article describes how that event played out.
June 27, 2019
by Dan O'Leary, President, Ombu Enterprises
Medical device makers could save themselves time and heartache in reducing the number of regulatory findings when it comes to the FDA’s CFR Part 820 quality system regulations and ISO 13485. How? By understanding the benefits you get by fully implementing process validation to achieve higher levels of compliance.
December 26, 2018
Jean-Christophe Gourmanel and Tifany Desprez, Apsalys, a MasterControl Partner
Now that you understand what the Medical Device Single Audit Program (MDSAP) is and how it can benefit your medtech company, learn more about MDSAP’s audit process and how to successfully steer your company through the specifics of the journey. This is Part 2 of a three-part blog series about MDSAP.
May 24, 2018
by Jerry Chapman, Editor-in-chief, Xavier Health, and GMP Quality Consultant
Experts at the FDA/Xavier PharmLink conference at Xavier University in March 2018 presented and analyzed the FDA's top 10 drug GMP inspection citations for FY2017 during a panel discussion. The second part of a two-part series.
May 10, 2018
by Patricia Santos-Serrao, Director of Product Strategy, MasterControl
A mock U.S. Food and Drug Administration (FDA) audit can be conducted by an internal team of employees qualified by experience in regulatory compliance or by an external team with previous FDA work experience. Incorporating routine mock FDA audits can help your organization prepare for a FDA audit as well as reduce the number of audit observations and repeat observations received from regulatory authorities.
September 21, 2017
by Laurie Meehan, Social Media Manager, Polaris Compliance Consultants
You use computers on a daily basis, and you may even use the system that needs to be audited. But you don’t spend your day thinking about where all the system components are located, how services and software are combined, and what Part 11 requirements apply.
March 2, 2017
Marci Crane, Staff Writer, MasterControl
For medical device manufacturers who plan to sell one or more products in Australia, Brazil, Canada, Japan and/or the U.S., the Medical Device Single Audit Program (MDSAP) is a valuable option for reducing regulatory burden while simultaneously demonstrating compliance against all regulations stipulated by the respective regulatory bodies of participating geographies.(1) According to the U.S. FDA’s MDSAP FAQ page “The MDSAP…is a program that will allow the conduct of a single regulatory audit of
March 1, 2017
Erika Miller, Food Safety Specialist, D.L. Newslow & Associates, Inc.
As a food safety and regulatory consultant, I work with diverse clients who face many different challenges with Food Safety Modernization Act (FSMA) implementation. The ones that are the hardest to address fall into the intersection between company policy and regulatory requirements. Supply-chain approval is a major challenge for many larger corporate clients, as well as smaller clients who must remain flexible to maintain profitability. The requirements of the Foreign Supplier Verification Prog
February 23, 2017
Ken Christie, COO, VTS Consultants
The topic of supplier audits can cause severe anxiety and headaches for many biopharma companies. This pain stems from the combination of having to understand the applicable regulations, determine the elements of a supplier audit in terms of criticality, establish the frequency and type of audits to be performed based on this evaluation, and follow-up on any issues found. Sufficient time is needed to prepare for and execute such activities, and time is one thing few of us have enough of. However
June 21, 2016
Dr. Christopher Joseph Devine, President Devine Guidance International
For the aerospace, defense, automotive, pharmaceutical or medical device industries, it really makes no difference when it comes to auditing the effectiveness of the quality management system (QMS): An established auditing program is a fundamental requirement. ISO 9001, ISO 13485, AS 9100, and the primary topic of most of Dr. D’s rants 21 CFR, Part 820 compliance, all have elements mandating that quality audits be performed. So the doctor always finds it quite disturbing when a device establishment fails to comprehend the importance of creating an audit schedule and actually performing the audits.
