How They Did It: Pfizer's Transition from 50 Document Management Systems to One

Like many other pharmaceutical companies, Pfizer has been through numerous mergers, acquisitions and divestitures. Two notable ones were the acquisition of Warner Lambert in 2001 and Pharmacia in 2003. The mergers, acquisitions and silo work practices fractured Pfizer's highly regulated and controlled documentation over many sites and systems. This included our GxP Standard Operating Procedures, product labeling, submissions management and trial master file systems.

Three Quality Management Tips to Avoid Death by CAPA - for Medical Devices Industry

It's been 10 years since the FDA introduced a regulation requiring that medical device manufacturers implement a formal corrective and preventive action (CAPA) system to monitor and manage the safety complaints associated with their products. Yet, managing a CAPA system remains a major challenge for many manufacturers.A sound CAPA system organizes and evaluates complaints, nonconformances, and other deviations about products and services to improve patient safety. But the problem is: How do you

Medical Device Firms Experiencing 'Death by CAPA?'

Eighty-eight percent of all Warning Letters issued by the FDA to medical device firms recently were related to CAPA deficiencies. Managing the CAPA process is a major challenge for most medical device companies. This problem can be so overwhelming that an FDA official called it "death by CAPA."Is your CAPA system helping or "killing" your organization? In the next issue, an article by Ken Peterson, senior partner of PathWise Inc., a leading CAPA training and consulting provider, will examine ris

Essential Elements of Effective CAPA Systems - Death by CAPA

The end result objective of a corrective and preventative action (CAPA) is, quite simply, a solution to the issue from which the CAPA was generated. If it is not driving toward a solution, a CAPA is a waste of time and resources. For organizations in regulatory environments, CAPA is an overarching umbrella—all control points flow through to the CAPA system.

FDA 21 CFR Part 11 And Predicate Rules Article

Ten years after the FDA issued 21 CFR Part 11, the agency is expected to issue a new guidance for compliance, even as it considers revising the regulation.

Communicating Priorities to Your Employees

Needless to say, if managers don’t understand corporate priorities, they can’t communicate them to employees. Entire departments may pursue the wrong priorities, causing stra­tegic corporate plans to become less effective. I’ve seen a lot of this. Likewise, if managers understand the priorities, but have not communicated them well to their departments, the results can be the same. And if employees are left to themselves to decide what the priorities are, not only are the efforts of your teams unlikely to match corporate goals, they probably won’t even match each other. You will likely have employees working in different directions, even within the same departments or even on the same projects.

How to Explain Your Quality Job to Young Kids in 4 Steps

When it was time to celebrate Career Day at my daughter’s school, she begged me to come talk to her first-grade class. I dreaded it. How do you explain to 6- and 7-year-olds what a quality manager does?

Have a Quality Holiday Season

Leverage TOQ for a Faster, Cost-Effective Software Validation

More and more regulated companies are using electronic quality management systems, but the concept of software validation remains a mystery to many engineers and quality professionals. In this article, I will try to shed light on the underlying goal of software validation within the context of FDA guidelines and offer a practical strategy.

On the Quality of Vendor/Supplier Audit Responses

After writing, revising, and signing the finalized audit report, most independent auditors move on to their next project.

Remote Audit: Out of Sight but Not Out of Mind

In life science and other regulated environments, audit is necessary to comply with regulations and to ensure the quality of products. Regulated companies recognize not only the importance of audit, but the value of frequent audits. However, in these economically challenging times, frequent on-site audits can be costly.

Surviving the Hosted Compliance Audit: Front Line, Back Room and in the Shop

Compliance audits present their own orientation to an organization that wants to present the perfect front while being asked to air their dirty laundry. Is this inspection about smoke and mirrors or does the audited facility present a "zipped-tight" posture toward the investigator?

Correcting and Detecting CAPA Horrors

The long history of Corrective and Preventive Action (CAPA) requirements within the Food and Drug Administration's (FDA) Quality System Regulations---and specifically 21 CRF 820.100 and ICH Q10---implies that most biomedical companies have evolved a certain level of mature thinking and a good understanding of the fundamental requirements for CAPA systems. This, unfortunately, is not always the case. I am currently spending a lot of time working with client companies in remediation mode; that is,

Corrective Action and Preventive Action: What's the Difference?

Note: The views expressed in this article are those of the author and do not necessarily represent those of his/her employer, GxP Lifeline, its editor or MasterControl, Inc.

Five CAPA Tips that Help Ensure Compliance

Having been intimately involved in how the U.S. Food and Drug Administration ("FDA") inspects current Good Manufacturing Practice ("cGMP") requirements for nearly two decades, I find myself repeating certain things to companies. Most often, the issues I repeat relate to Corrective and Preventive Action ("CAPA") systems. CAPA systems are a focal point in FDA inspections precisely because they are the process that manufacturers follow in case something goes wrong. In the same way that a person'

MasterControl Presents 'Change Control, a Risk-Based Approach' at MD&M Texas

MasterControl Inc. will present "Change Control--a Risk-Based Approach" as a workshop at the MD&M Texas 2012 Conference, March 15, 2012, at the Fort Worth Convention Center in Fort Worth, Texas. MasterControl's Kevin Marcus, product manager and medical device expert, and Walt Murray, director of quality and compliance services, will conduct the workshop.

Is Quality by Design just for Big Pharma?

Note: The views expressed in this article are those of the author and do not necessarily represent those of his/her employer, GxP Lifeline, its editor or MasterControl, Inc.

Contract Management: What's Compliance Got to Do with it?

Contracts are typically the purview of the finance and legal departments. But in regulated environments, the regulatory, quality, and other departments might also be involved in the contract management process.

What SOPs Do You Need As A Dietary Supplement Distributor?

If you look at the cGMP regulations for dietary supplements, you'll notice that only one subpart includes the words "holding" or "distributing" in its title. With only 10 or so individual requirements, the aptly-named Subpart M, "Holding and Distributing," is shorter than most. If you're thinking this means there's a much lighter regulatory burden placed on companies that simply hold or distribute dietary supplements than on companies that manufacture them, you'd be right. At the same time, y

Ten Points for Successfully Addressing Warning Letters

Each year, the FDA issues hundreds of warning letters to medical device companies for reasons ranging from manufacturing practice violations to breaches in labeling and misbranding. Companies responding well to the FDA’s demand for prompt compliance will ultimately return to the agency’s good graces and through the experience develop processes that result in better business, both culturally and financially. But getting to that point may be a slippery slope if the issues in the letter are not