2013 Posts

Living a Quality Corporate Culture

Living a Quality Corporate Culture

Kari Miller, Sr. Director of Industry Solutions & Product Management, Pilgrim Quality Solutions

A culture of quality requires teamwork.  Teamwork is the natural result of working in an environment where people feel they are part of something bigger than themselves. When personal success on the job is defined by the success of that something bigger, an organization has achieved a critical ingredient for a quality culture. The company’s welfare, and therefore the employee’s welfare, is also directly tied to that of its suppliers and customers. (more…)

Quality is Everyone’s Job

Quality is Everyone’s Job

Kari Miller, Senior Director of Industry Solutions and Product Management, Pilgrim Quality Solutions

Vision, values, goals and strategy are the guiding principles of a corporation and culture culminates from them. Quality culture refers to the complete awareness, commitment, attitude, and behavior of the organization with respect to quality.  Corporate leadership must effectively communicate and more importantly demonstrate quality as an inherent value of the organization. (more…)

Crafting a Quality Culture

Crafting a Quality Culture

Kari Miller, Senior Director of Industry Solutions and Product Management, Pilgrim Quality Solutions

Most people in industry are familiar with W. Edwards Deming, Joseph Juran, Jim Harrington, and others whose ideas are usually grouped under the term Total Quality Management. However, the practices they embrace aren’t just about Total Quality Management; they are about management best practices which embrace a culture of quality.
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Measuring the Success of Training and Competency

Measuring the Success of Training and Competency

Konyika Nealy, Vice President of Quality Assurance & Validation, Pilgrim Quality Solutions

According to 21 CFR Part 211 Subpart B, Section 211.25 (Personnel Qualifications),

Each person engaged in the manufacture, processing, packing, or holding of a drug product shall have education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions. Training shall be in the particular operations that the employee performs and in current good manufacturing practice…as they relate to the employee’s functions.

But what does an effective training program look like?  How do you measure success? (more…)

Pushing Paper (Or Not): Cloud-based Document Management Saves Time, Reduces Risk

Pushing Paper (Or Not): Cloud-based Document Management Saves Time, Reduces Risk

Mark Crawford

Sometimes the most important step in a successful product launch is knowing where the documents are—getting delayed by not being able to find the documents the FDA insists on seeing (or worse, having to start over) is a major drag.  The same is true when it comes time for an FDA audit. (more…)

FDA’s New RTA Policy Is Just What Some Companies Need

FDA’s New RTA Policy Is Just What Some Companies Need

Mark Crawford

The FDA’s updated Refuse to Accept (RTA) policy for 510(k) applications that lack required documentation is now in effect.  The draft version was issued last summer.

This new policy outlines an early review process for 510(k) applications to determine whether they contain all the required materials for starting a substantive review. (more…)

Get with the (Management) Program… for a Change

Get with the (Management) Program… for a Change

Konyika Nealy, Vice President of Quality Assurance & Validation, Pilgrim Quality Solutions

Social networks, outsourcing, mobile apps, expiring patents, mergers and acquisitions, are but a few landmarks in the last 10 years that have changed the way business is conducted forever.  If nothing else, industries have acknowledged that they must embrace change to remain competitive and protect market share.  As such, regulated industries such as life sciences, must adopt a proactive and systematic method to integrate new technologies and efficiencies while preserving the quality, safety and efficacy of their products and services. (more…)

Don’t Guess on Variation and Corrective Action

Don’t Guess on Variation and Corrective Action

Mark Crawford

Jonathan D. Port, a quality management expert and owner of Beacon Quality Services LLC (www.beaconquality.com), wrote an article on understanding variation in the March 2012 issue of Quality Progress.

“Organizations with quality management systems compliant to ISO 9001:2008 are required to take action to eliminate the causes of nonconformities,” says Port. “Clause 8.5.2 defines steps required for corrective action (CA), including determination of the nonconformity cause, along with determination and implementation of necessary action to prevent recurrence. Similar wording is also present in clause 8.5.3 regarding preventive action (PA).” (more…)

Will the Medical Device Tax Go over the Fiscal Cliff?

Will the Medical Device Tax Go over the Fiscal Cliff?

Mark Crawford

At the time of this writing the fiscal cliff still looms large—as Republicans and Democrats parry and thrust regarding what gets cuts and what doesn’t, some members of Congress are trying hard to get medical device tax cut from the final spending bill. (more…)

Time For SaaS?

Time For SaaS?

Michael Reynolds

Outsourced Enterprise Compliance and Quality Management  — application and data management in the form of Software as a Service (SaaS) — is a partnership needed more  today than ever, particularly in the increasingly complex regulatory environment that Pharma, Biotech and Medical Device companies find themselves. (more…)