Audit Posts

Quality within the BioPharma Industry Landscape

Quality within the BioPharma Industry Landscape

Florian Czaszewicz, Industry Solutions Consultant, Pilgrim Quality Solutions, an IQVIA company

The American Society for Quality, touted as the “Global Voice of Quality,” states that manufacturers in the pharmaceutical industry are always working to balance the demands of meeting global regulations and production costs, in an effort to produce the most innovative research and development while also producing safe, reliable prescription drugs. As a biopharmaceutical industry veteran, I know the challenge is real. In fact, when illustrating a graphic representation of the Biopharma industry’s information management landscape, as I see it, the depiction is quite dense and complex. (more…)

Top Concerns for Quality Audits: 5 Highlights from Last Week’s SmartSolve Audit Management Webinar

Top Concerns for Quality Audits: 5 Highlights from Last Week’s SmartSolve Audit Management Webinar

Roxane Napoli, Marketing Manager, Pilgrim Quality Solutions

Recently, we hosted two live demonstrations of SmartSolve Audit Management. The webinar covered a number of topics including how to perform mobile audits, creating audit programs and schedules, working on audits, and managing audit followup.  The webinar also included live Q&A during both sessions.

Some key themes emerged during both sessions that helped us understand the challenges you may encounter when carrying out quality audits, and how SmartSolve Audit Management can help.

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What I Learned Through Surviving an Internal Audit

What I Learned Through Surviving an Internal Audit

Adonna Blasko, Marketing Manager, Pilgrim Quality Solutions

It takes a substantial amount of planning and effort to carry out an internal audit, but the outcomes can improve your processes, the performance of your department, and your outlook. As you’ll soon see, undergoing an internal audit can be a learning experience regardless of your skills or expertise within the organization.

Now, here’s a slight disclaimer: As part of a marketing department, the processes I touch and work through are not directly related to product safety or risk. However, our marketing internal audit was a necessary preparation to drive our entire organization toward our ISO 9001:2008 certification. The tips that follow are not solely relevant to marketing, or to any particular process or department, but reflect a broad overview of what I learned through participating in the audit process. (more…)

How to Prepare for Your Next FDA Inspection (Free E-Book)

How to Prepare for Your Next FDA Inspection (Free E-Book)

Roxane Napoli, Marketing Manager, Pilgrim Quality Solutions

Think about your next FDA inspection. How will you feel when the inspection arrives at your facility? Will you be rushed or calm? Flustered or confident? Perhaps more importantly, who will control the direction of the inspection? You… or the inspector?
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The Anatomy of Great Risk-Based GMP Audits

The Anatomy of Great Risk-Based GMP Audits

Roxane Napoli, Marketing Manager, Pilgrim Quality Solutions

If you’re responsible for planning and carrying out your company’s internal audits, you know how much planning and effort it takes to monitor your quality system for GMP and ISO compliance. As your quality system has matured, you’ve probably noticed that certain sites, departments, or processes require more of your attention, while others are consistently in compliance and don’t need as much assistance. If this is the case in your organization, it’s time for you to consider a risk-based approach to your internal quality system audits. (more…)

Medical Device Single-Audit Pilot: Will it Fly?

Medical Device Single-Audit Pilot: Will it Fly?

Sandy Carson Hessen, Marketing Communications Manager, Pilgrim Quality Solutions

We’ve all seen them. Some flop, some fly. Television Pilots — stand-alone episodes of television series used to sell shows to the networks by gauging whether a series will be successful. After seeing this sample of the proposed program, networks then determine whether the expense of additional episodes is justified.

There’s another type of pilot airing right now in the Medical Device industry, and the purpose is similar. (more…)

Unannounced Regulatory Audits Hitting Global Med Device Community

Unannounced Regulatory Audits Hitting Global Med Device Community

Sandy Carson-Hessen, Marketing Communications Manager, Pilgrim Quality Solutions

No one likes to be caught off-guard. Have you ever had a contractor show up at your home before you’ve even woken up? Or your child tells you he needs his original birth certificate the very next morning to register for camp. These facts of life often arise when you least expect it. (more…)

The Role of the Internal Quality Auditor

The Role of the Internal Quality Auditor

Konyika Nealy, Vice President of QA and Validation, Pilgrim Quality Solutions

As an experienced member of your organization you may at some time be called upon to conduct an internal audit. This is a good thing. Internal audits are intended to preempt issues that can arise during a second or third party audit. This type of peer review though, if not managed correctly, can have negative consequences that undermine its value.
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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…)

Product Liability: How Exposed Are You?

Product Liability: How Exposed Are You?

Mark Crawford

According to regulatory compliance expert James Kolka, management too often ignores the legal and financial threats posed by product liability lawsuits.

“Management often believes that compliance with FDA’s Quality System Regulation (QSR) protects the company from product liability exposure,” says Kolka. “Consequently, the task of product liability management is invisible and not audited. It seems to materialize when there is a lawsuit and a mad scramble to find who is or should have been responsible.” (more…)