Apr 15, 2014

Report from MD&M West Conference: NAVIGATING THROUGH THE PMA AND 510(K) SUBMISSION PROCESSES


Report from MD&M West Conference: NAVIGATING THROUGH THE PMA AND 510(K) SUBMISSION PROCESSES

By Peter Knauer, Senior QCC Consultant, MasterControl Inc.



I recently had the opportunity to chair a track and present a session on FDA and a Global Regulation in Practice at the MD&M West Conference. The conference was held at the Anaheim a Convention Center from Monday, February 10th through Thursday February 13th, 2014. Below is a summary of the proceedings for Day 2: NAVIGATING THROUGH THE PMA AND 510(K) SUBMISSION PROCESSES.

Apr 10, 2014

Leverage TOQ for a Faster, Cost-Effective Software Validation


Leverage TOQ for a Faster, Cost-Effective Software ValidationBy Richard Dirkson, Senior Validation Services Consultant, MasterControl Inc. 

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. 

Apr 8, 2014

On the Quality of Vendor/Supplier Audits Responses

On the Quality of Vendor/Supplier Audits Responses

By John Janeri, Independent CSV/Part 11 Auditor working with Polaris Compliance Consultants.

Edited by Laurie Meehan, Social Media Manager, Polaris Compliance Consultants, Inc.

After writing, revising, and signing the finalized audit report, most independent auditors move on to their next project.  I’ve done many of these solo audits, and I’ll admit that I've often wondered who at the Sponsor* company would communicate the findings to the Auditee and review their responses.  But no matter, I've completed the contracted assignment and I'm now off doing something else, right?  Not so much anymore.

In the past few years, I've noticed that many companies are now asking me to stick around a lot longer.  Some Sponsors are beginning to realize that there are benefits to maintaining continuity throughout the entire audit process by involving the auditor in the “follow-up” activities.  This seems natural since it appears to provide a level of consistency to their vendor qualification assessments that would otherwise be absent.
After the audit report is finalized, Sponsors frequently will ask me to gather up a summary of all the observations and send it to the Auditee in the form of a draft Action Plan.  I may also be asked to help the Sponsor review and comment on the Auditee's responses to the observations (i.e., the Auditee's completed Action Plan).  After all, since I’m the one who observed the deviation, I’m probably in the best position to assess the Auditee’s plan to remediate it.

Apr 3, 2014

Demystifying FDA/CDRH Appeals Process

Demystifying FDA/CDRH Appeals Process By David Lim, President and Principal of Regulatory Doctor
and
Yoonhee Beatty, Regulatory Affairs Associate, Bard Access Systems, Inc.

We present a summary of available options to request additional review of FDA decisions or actions, including how to choose an option when a stakeholder has reasonable grounds to disagree with FDA/CDRH’s decision.  It is worthwhile to note and get familiarized with the available options.  However, it is recommended the stakeholder try to avoid having such situations in the first place.
Avoiding a Dispute
The key to avoiding the FDA appeals process is to enhance your awareness and understanding of evolving regulatory issues. It is crucial to establish good knowledge of the perspectives and viewpoints of a given issue between the FDA and the stakeholder. More often than not, issues between the FDA and stakeholders arise from different interpretations and expectations of laws, regulations, rules, policies, scientific and technical requirements and how they should apply to the case on point. It is important to understand the reasoning of the FDA on a particular issue so that a sponsor can effectively address the issues with scientifically sound and justifiable reasons supported by data.   

Differences in opinion between the FDA and the stakeholder’s view can be addressed early on in the process through open communication. Here are some practical tips to minimize such differences in perspective early in the process.  

Apr 2, 2014

Making SMART Choices When Managing Quality Events: More Helpful CAPA Tips

By James Jardine, Marketing Communications, MasterControl Inc.

A previous blog post provided an overview of a portion of quality guru Ken Peterson’s “Taking Effective Action” webinar (the second of a three-part series) that outlines the keys to successful CAPA programs. This post summarizes the remainder of the second webinar in the series which can be viewed here.

Peterson provides a handy acronym to help us remember to make SMART actions when managing quality events and he provides helpful examples of each principle:

  • Specific: Is the action well stated and easy for the affected departments and stakeholders to understand?
  • Measurable: Can the action be validated and verified so that confirmation can be made easily in order to determine whether or not the action is indeed solving the problem?
  • Aligned: Does the action relate specifically to the root cause or is it possible that it is more closely related to a different cause?
  • Realistic: What makes you believe the action can actually be accomplished? Do you have the resources to take the action?
  • Time Bound: When does the action need to be accomplished? Are speed and efficiency factors?

Using the SMART criteria, Peterson gives some specific examples that illustrate how actions can and should be taken. He also reiterates the importance of documenting all actions. 


Apr 1, 2014

MasterControl 's Ken Peterson and Patricia Santos-Serrao Featured SQA Speakers



By Robyn Barnes, Marketing Communications, MasterControl Inc.

MasterControl will provide demonstrations of its document management and quality management solutions at the 30th Society for Quality Assurance (SQA) Annual Meeting to be held April 6-11, 2014 at the Cosmopolitan of Las Vegas in Las Vegas, Nevada.
Ken Peterson, MasterControl’s director of quality and compliance, will present “Overcoming Death by CAPA: Closing Your Quality Loops.” Peterson is a recognized CAPA expert who is a regular speaker at SQA.  He has more than 25 years' experience in consulting and organizational change, quality management and product development.  He frequently travels across the world consulting and educating companies and agencies on quality management and regulatory issues to help them improve efficiency and ensure compliance.


Mar 26, 2014

Changing Supplier Controls Requirements


Changing Supplier Controls Requirements

By John E. Lincoln,  J.E. Lincoln and Associates

Companies that choose to produce medical products come under the regulatory laws of the countries in which they market their products.  For the U.S., this falls under the purview of the U.S. FDA, with its CGMPs, “Current [best practices] Good Manufacturing Practices”, as codified in 21 CFR 4, Combination Products, 21 CFR 111, Dietary Supplements, 21 CFR 211, Pharmaceuticals, and 21 CFR 820, Medical Devices, and others. 

For much of the rest of the world, the European Union provides a major model, with its directives, emerging CGMPs,  and the ISO quality standards -- ISO 9001 for the majority of quality management systems, and ISO 13485 for medical device QMS. 

All these regulatory requirements mandate that a company establish a ‘total quality system,’ from customer requirements through development, procurement (supplier control), production, to customer use and feedback.   

Mar 25, 2014

Taking Effective Actions: CAPA Webinar Part 2

By James Jardine, Marketing Communications, MasterControl Inc.

Taking Effective Actions: CAPA Webinar Part 2In the second webinar of a three-part series from MasterControl, quality expert Ken Peterson demonstrates how companies can develop better corrective and preventive actions (CAPA) to ensure quality and compliance. In the second installment, Peterson focuses on key decision points and the types of actions that should be taken depending on the quality event. He points out the importance of containing issues at the department level, if possible, before moving them into a formal CAPA process. Peterson discusses four possible actions to be taken when dealing with quality events: no action (the “wait and see” approach), corrections (with a focus on the immediate situation or containment), corrective actions, and preventive actions (to preemptively deter issues from occurring in the future). 


Mar 20, 2014

An Introduction to Metrics Collection and Usage


By Christopher Ball, Senior Professional Services Consultant, MasterControl Inc.

An Introduction to Metrics Collection and Usage
Most companies understand that the collection of data can be valuable but often don’t really rationalize what they want to collect.  Why collect data for “A” rather than data for “B”? Wouldn’t it be better to collect it all?
The problem is there is so much data available, much of it with an automatic collection option, that it’s easy to accumulate it.  The downside of blindly taking this approach is data saturation.  There’s so much to look at that nothing is done to analyze it.  Because the data isn’t analyzed, no action is taken based on the findings.  Effectively, the company drowns in data at best or worse still, makes random and or variable assumptions about the interpretation of the data. As a result, the company could make flawed and maybe fatal business decisions because “the data indicated …..”
The intention of this article it to put some simple steps into the armory of your business so that you won’t waste valuable resources collecting data you won’t use, need, or want.  Instead, collect data that fits with your business direction and strategy---data you can analyze appropriately and use to make balanced informed decisions.  You’ll see that having data and analysis that business management can trust has value.

Mar 18, 2014

Making the Business Case for Implementing an Electronic QMS

Making the Business Case for Implementing an Electronic QMS

By: Lisa Weeks, MasterControl Inc., Marketing Communications 

In a tough economy, quality professions often find themselves having to convince management that swapping their paper-based QMS for an electronic one is worthy of the expense and will translate into bottom-line, as well as compliance, benefits. While the regulatory and legal drivers for automating your quality processes are irrefutable, the frequently overlooked operational and business opportunities enjoyed by organizations that implement an electronic QMS are equally compelling. Simply put: compliance is good for business, and the right QMS software can help you transform your compliance challenges into tangible business advantages. 

Study Shows QMS Software Has Become a Top Priority in Best-in-Class Companies

QMS software is becoming commonplace in best-in-class organizations. According to AMR Research, quality management has moved from an afterthought to a strategic priority, topping the list as the most important software component in supply chain risk visibility. (1) What’s prompting the increased demand? No doubt it’s the intense and mounting scrutiny from the FDA, EMA, ISO, and other global regulatory agencies. But regulatory pressure isn’t the only thing keeping CEOs, CFO, and other senior executives up at night. Here are some commercial advantages to automating your quality processes, such as document controlemployee training recordscorrective action, and risk management, that will resonate strongly with senior management and stakeholders. 

Mar 13, 2014

Sound Risk-Based Decision Making in Process Validation

By Robyn Barnes, Marketing Communications, MasterControl Inc.

MasterControl’s Walt Murray recently returned from a speaking engagement at MD&M West.  I asked him for impressions of the conference.
Do you know the difference
between the decision-making process
and root cause investigation?

“The exhibition was massive,” he said.  “It was a great event for us.  There were so many people everywhere you went that it felt like a real crush. I’ve got to tell you that a foot massage every night would have been really useful. “
During the meeting, Walt taught a class on “Conducting the Validation Protocol, Collecting and Analyzing the Data.”  
“Normally, this might not be the most exciting class to attend, especially right after lunch,” he says.  “But we had a full room.  The discussion was lively and ranged from the importance of quality decision-making to solid event management.  I was surprised to discover that many people were not clear on what solid event management means.“ 

Mar 11, 2014

Four Team Members to Include When Building Your Software Implementation Dream Team (and Two to Avoid).

Team Implementation

By Stephanie Jones, Professional Services Consultant, MasterControl Inc. 

According to a study by Gartner Research, nearly four in ten major software purchases end up as “shelfware,” i.e., software that is purchased and never implemented or only marginally configured and/or deployed. Why? Often, it is because of the application itself or the perceived unresponsiveness of the software vendor’s implementation consultants. Rather than compromise efficiency, or redesign proven processes which took years to develop and implement, an organization will opt to delay or abandon a software rollout, resulting in a significant waste of financial and human resources.

But a complex application and/or poor communication on the part of the provider are not the only factors than can halt or completely derail your implementation. While selecting the right application/vendor is critical, and this is true regardless of the application, whether it’s an enterprise resource planning (ERP) solution or a quality management solution (QMS), it’s equally important that the customer organization assign the right people to its internal implementation team.

After nearly 30 years of working with literally hundreds of teams to implement a variety of software applications in highly regulated companies, I have developed a theory about who belongs on the customer’s implementation team—and who doesn’t. First, let’s talk about who doesn’t.