Pilgrim Quality Solutions Posts

Defining the Pharmaceutical Supply Chain: Start at the beginning

Defining the Pharmaceutical Supply Chain: Start at the beginning

Kari Miller, Regulatory and Product Management Leader, Pilgrim Quality Solutions, an IQVIA company

The standard supply chain within the Pharmaceutical industry is complicated. It is subject to strict regulations and industry best practice standards. In addition to heavy oversight from regulators, industry, and consumers, the intricate structure of the Pharmaceutical supply chain, as well was its global nature, add to its complexity. The emergence of India and China, where there are now many excipient, API, and CMO suppliers, exemplify that global nature. This expansion on the global stage adds another serious layer of complexity. With distance, comes risk — the risk that something could go wrong not only in manufacturing, but in transit.

With so much at stake, a manufacturing organization must focus its vision from the very beginning. (more…)

The Future of Pharmaceuticals

The Future of Pharmaceuticals

IQVIA

It is an exciting, and formidable, mandate – to solve the world’s healthcare challenges. To continually find new ways of delivering value and real outcomes to patients, providers, and payers. To rise to the challenge to be more precise, from clinical trials to commercialization. To make the most out of increasingly limited resources. And to minimize while maximizing success. That is what IQVIA, the Human Data Science Company, is about.

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The Compliance Roadmap

The Compliance Roadmap

Mark Scallon, Senior Principal, Commercial Compliance, IQVIA

As regulatory changes continue in the EU and the U.S., life sciences companies will need to focus more on rigor and reproducibility with respect to non-clinical, pre-clinical, clinical data, and post-market data, in addition to the subsequent documentation and audit challenges. (more…)

Transform Your Approach to Compliance From Concept to Market

Transform Your Approach to Compliance From Concept to Market

Bill Buzzeo, General Manager, U.S. Center of Compliance Excellence, IQVIA

Today’s drug and medical device manufacturers have several common challenges. First, nearly all are being impacted by the shifting global regulatory compliance environment as they simultaneously strive to stay ahead of the competition while safely and effectively meeting the needs of patients. Additionally, compliance has typically been seen as a department, not a shared responsibility, and collectively perceived as a cost center, not a value center. (more…)

Supplier Risk and its Impact on Corporate Risk

Supplier Risk and its Impact on Corporate Risk

Kari Miller, Regulatory and Product Management Leader, Pilgrim Quality Solutions, an IQVIA company

Risk continues to be a major focus in most businesses today, regardless of industry. In the past few years, Life Sciences organizations have seen a steady rise in supply chain issues resulting in lost market caps, recalls, regulatory fines, and other financial impacts valued in the billions of dollars. Subsequently, the standards organizations and regulators around the globe have taken note and responded accordingly. So it’s no surprise that minimizing business and operational risks, as well as legal and regulatory compliance, is on every executive’s mind, and for good reason.

Supplier risk, put simply, is the probability associated with a supplier causing an interruption in an organization’s supply chain by impacting the availability of products and services within that supply chain. Supplier impact, at a minimum, effects two legs of the three-legged Governance, Risk, and Compliance (GRC) stool: those two legs are Risk and Compliance. The impact of suppliers on an enterprise can be significant. (more…)

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…)

A Deviation by Any Other Name

A Deviation by Any Other Name

Kari Miller, Regulatory and Product Management Leader, Pilgrim Quality Solutions, an IQVIA company

What’s in a name? Depending on industry, a word can have very precise meaning. Look up the word “deviation” on the internet and the first definition to appear reads: noun, The action of departing from an established course or accepted standard. Statisticians use the term to define “The act of deviating” or “Deviation from a norm”.

If you search for the definition of “deviation” as applied in the Pharmaceutical industry, you’ll find some variation of “Unexpected departure from an approved instruction, procedure, established standard or specification.” In other words, “deviation” is not a desirable term in the Quality lexicon. (more…)

Continuing Education in the Quality Space

Continuing Education in the Quality Space

Lynn Willis, Partner Enablement and Training Manager, Pilgrim Quality Solutions, an IQVIA company

An important facet of any organization’s quality efforts is the knowledge of its personnel. The depth of each employee’s knowledge and skills contributes to the company’s ability to achieve its mission and goals. Conversely, employees who do not have the knowledge to perform their day-to-day functions pose a quality risk. This equation applies as much to long-time employees as to new hires. (more…)

Limit the Stakes with Risk-Based Employee Training

Limit the Stakes with Risk-Based Employee Training

Lynn Willis, Partner Enablement and Training Manager, Pilgrim Quality Solutions, an IQVIA company

Employees often know little about product liability and the role they have in the company’s overall risk profile. The acts or omissions of even one employee can have severe financial and operational consequences for companies. Employee risk management training is essential to bridging the awareness gap.

With the adoption of ISO 13485:2016, Life Sciences manufacturers have stepped up their risk-based training requirements. What about your organization? How do you currently define training requirements? If you’re not considering risk as you define them, you will need to add this consideration into your process. (more…)

EU MDR: T-Minus 500 Days…Are You Equipped?

EU MDR: T-Minus 500 Days…Are You Equipped?

Mark Rhys Burke, Senior Account Executive, Pilgrim Quality Solutions, an IQVIA company

In May 2017, the European Union (EU) embarked upon a three-year transition period designed to give medical device manufacturers time to comply with new regulatory requirements. The enforcement deadline for compliance with the Medical Device Regulation (EU MDR) is May 26, 2020. That deadline is looming large for everyone in the industry.

That said, I regularly speak to individuals who express trepidation about this rapidly approaching date. They simply don’t have the necessary documents and data prepared to meet the stringent new requirements – and they’re not alone. A recent survey of more than 200 regulatory and quality leaders at major medical device companies showed that 78% of those polled did not have sufficient understanding of the new regulations. (more…)