GxP Lifeline

Showing items tagged as Pharma

Six Steps to Qualifying Suppliers

16 June, 2016 by Robert Packard, Packard Consulting

Imagine that you are a QA consultant. Last night you wrote a blog about the three tools needed to qualify suppliers. Today you are auditing a supplier, and have just complimented the purchasing manager on his quality program. During lunch, Kim, the general manager, says, “Michael was just showing me the blog you wrote about how to qualify suppliers. I was confused—your blog seemed to say that we are doing everything wrong, but you just told us that our supplier quality program looks great.”
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What, No Internal Audits?

21 June, 2016 Dr. Christopher Joseph Devine, President Devine Guidance International

For the aerospace, defense, automotive, pharmaceutical or medical device industries, it really makes no difference when it comes to auditing the effectiveness of the quality management system (QMS): An established auditing program is a fundamental requirement. ISO 9001, ISO 13485, AS 9100, and the primary topic of most of Dr. D’s rants 21 CFR, Part 820 compliance, all have elements mandating that quality audits be performed. So the doctor always finds it quite disturbing when a device establishment fails to comprehend the importance of creating an audit schedule and actually performing the audits.
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What Will Quality Look Like in 20 Years?

12 July, 2016 Peter J. Holtmann, President and CEO, Exemplar Global

To look to the future, the quality profession is revisiting its roots. The question is, “Where is the next generation to help the profession look ahead?” Or, as I like to think of it, “What’s the emoticon for quality?”
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Your Suppliers’ Risk Is Your Risk

14 July, 2016 By Carrie Mantey

In today’s day and age, in which outsourcing can be the norm, and not only major global corporations stretch across the globe, but also potentially mid-market and mom-and-pop suppliers, supply chains are no longer insulated from external or environmental risk events. These risks can range from a natural disaster, such as the Japan earthquake and tsunami, to lax safety policies, in the case of the Bangladesh garment factory collapse, to the regular ebb and flow of business, including when a supplier is acquired or goes out of business. These risks are not new to the supply chain, but as the supply chain grows more complex, so do the risks to supply, especially when visibility is blurred, suppliers are far-flung and there is no backup plan in sight.
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The Proper Role of the FDA in the 21st Century

21 July, 2016 Dr. Joseph Gulfo, Executive Director, Rothman Institute of Innovation & Entrepreneurship

The current medical marketplace is vastly different from the marketplace that existed when the basic elements of Food and Drug Administration law were passed. Despite rapidly advancing technology and patients’ increasing desire to try new drugs and devices, the FDA has strayed significantly from the statutorily defined safety and effectiveness standards for drug approvals. The FDA now very often demands proof of clinical utility, including survival and disease outcomes, as a requirement for premarket approval. But hard proof of clinical utility is elusive, even for drugs that are clearly shown to be safe and effective as labeled. Rather than blocking safe and effective drugs on such grounds, we should allow physicians and patients to make outcome-oriented decisions, and rely on the medical marketplace to drive physician adoption of safe and effective drugs that prove to have great clinical utility in real-world settings.
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A Warehouse Love Song

26 July, 2016 Laurie Meehan, Social Media Manager, Polaris Compliance Consultants, Inc.

Storing stuff doesn’t sound like it should be difficult, but complying with FDA’s detailed regulations for warehousing pharmaceuticals can be. To start, your warehouse has to be clean and pest-free. Dirt, insects, lubricants, or other agents could compromise the packaging or prevent labels from adhering. Your facility also needs proper drainage, ventilation, adequate space, and work lighting. (Is your warehouse susceptible to flooding? Do cramped or dark conditions increase the likelihood of dangerous product mix-ups?) You also have to make sure your product is not exposed to more heat, cold, humidity, or light than stability testing recommends. (Do you have moisture and temperature sensors throughout? Is the heat tunnel you use for sealing shrink wrap too hot? Do you have backup refrigeration? Have all of these devices been cleaned, serviced, inspected, and calibrated?) And what are your procedures if you find any safety threshold has been exceeded? Are your people adequately trained?
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Identifying and Preventing Common Data Integrity Issues

20 September, 2016 Joanna Gallant, Owner/President, JGTA LLC

Because of the multitude of problems being found in regulatory agency inspections, data integrity is a hot issue for regulators around the world today. Data integrity is critically important to regulators for a variety of reasons, including patient safety, process and product quality. The integrity and trustworthiness of the data provides a baseline for the regulators opinion of the personnel and the company as a whole.
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Tweet This — If You Want to be Slapped with an FDA Warning Letter

27 September, 2016 Lisa Weeks, Marketing Communications, MasterControl

Is the FDA starting to get serious about how medical devices and prescription drugs are being marketed on social media? Many experts think so, citing Kim Kardashian’s highly publicized misleading endorsement of the morning-sickness medication Diclegis® as an example. The offending post, which appeared on the reality star’s personal Instagram page, earned drug maker Duchésnay a warning letter, demanding an immediate retraction. The post was promptly removed—after it had garnered 450,000 likes from Kardashian’s over 42 million followers.
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Renowned Physician Patch Adams Urges Techies to Help Build an Ethical World

18 October, 2016 Cindy Fazzi, Editor, MasterControl Insider

Patch Adams, the physician famously played on the silver screen by Robin Williams, urged IT professionals to help build an ethical and nonviolent world during his keynote speech at the 2016 Masters Summit in Salt Lake City.
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10 Tips for Enabling Better CRO-Sponsor Collaborations

19 October, 2016 Craig Morgan, Head of Marketing goBalto, Inc.

By 2020 72% of clinical trials are anticipated to be outsourced, up from just 23% in 2012. Sponsors are seeking cost reductions, access to specialized knowledge, and increased speed and agility. Meanwhile, CROs focus is on business goals related to economic outcomes for their owners, investors and shareholders. Each group is expecting deliverables and timelines to be met or exceeded for potentially different business reasons, leading to a traditional client/vendor-type relationship. Though alliances and partnerships are increasing, there continues to be a client/vendor mentality at the operational and management levels, which perpetuates a lack of trust and empowerment.
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Retraining and Refresher Training: Aren’t They One in the Same?

2 November, 2016 Vivian Bringslimark, HPIS Consulting, Inc.

Ask an operations manager and he’ll acknowledge that what it’s called is less important than getting the “assignment” done and entered into the LMS. He’s usually more concerned about the loss of productivity during the training than the effectiveness of the training at that time. It isn’t until later when the training may have to be delivered again (repeated), that the comment “training doesn’t really work” is heard.
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How Frances O. Kelsey Blazed a Trail for Women in Regulatory Compliance

3 November, 2016 Jon Beckstrand, CEO, MasterControl Inc.

Whether it’s the ibuprofen we take to remedy a headache or the world’s smallest pacemaker approved by the FDA earlier this year, we can rest assured that these medical products passed scientific scrutiny and complied with stringent regulations. We can thank a woman who blazed a trail at the FDA—Frances Oldham Kelsey—for raising the bar in compliance.
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Optimizing Outsourcing Options for Small Sponsors

10 November, 2016 Laurie Meehan, Social Media Manager Polaris Compliance Consultants, Inc.

What can small sponsors do to secure the outsourcing resources they need as large CROs form strategic alliances with Big Pharma?
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Process Validation: Life Cycle Approach Beats Crossing Your Fingers

15 November, 2016 David Jensen

f you do something right three times, you should be able to do it that way always. If this is your approach to process validation, Hal Baseman, chief operations officer at ValSource LLC, begs to differ. Baseman shared some insights about improving process validation at the PDA/FDA Joint Regulatory Conference in Washington D.C., Sept. 12-14.
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GCP Compliance: Eliminating Silos between Clinical Quality and Clinical Operations

29 November, 2016 Patricia Santos-Serrao

In a classic episode of Seinfeld, George Costanza is terrified of the potential ramifications of his “worlds colliding” when his fiancée, Susan, becomes friendlier with his dubious pals Elaine, Kramer and Jerry. “Everybody knows you’ve got to keep your worlds apart,” George rants (but when does George not rant?) “If Susan is allowed to infiltrate this world then George Costanza as you know him ceases to exist. If Relationship George walks through this door, he will kill Independent George! A George divided against itself cannot stand!”
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Better IT Tools Mean Better Results

1 December, 2016 David Cornwell

An essential and growing component of the workforce, knowledge workers are those individuals whose primary role is the creation or management of information. Document collaboration is an increasingly common component of these workers’ daily tasks. In fact, research conducted for PleaseTech by Osterman Research reveals that during a typical month, knowledge workers create an average of 36 documents on which they will need to collaborate with others, while also being asked to collaborate on a further 34 documents. That total of 70 documents a month equates to an average of more than three documents a day.
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Santa Claus Is REAL but He Requires an EQMS!

20 December, 2016 Marci Crane

Once upon a time your parent or some “responsible” adult decided to be a big dope and tell you that Santa Claus wasn’t real. You, always the awesome kid on the block, took the news with grace but nevertheless it carved a scar onto your tender little heart.
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5 Ways Artificial Intelligence Is Changing Health Care and What It Means for Quality Management

27 December, 2016 Beth Pedersen, Marketing Communications, MasterControl

Health care data is expected to reach a staggering 2,300 exabytes (one exabyte is equal to one billion gigabytes) in 2020. We all know knowledge is power, but the amount and complexity of data in existence has long since outpaced the human mind’s ability to access and process it. Enter artificial intelligence (AI). Since its inception over half a century ago, AI has experienced an ebb and flow of attention, investment, development and scrutiny but one idea persists: the promise of making human lives significantly better.
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"Hacking" Quality

13 September, 2016 Peter Holtmann, President & CEO, Exemplar Global Inc.

Continuing my theme of the future of quality, the ability to see the future could come through some interesting lenses—hacking, for instance.
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5 CAPA Best Practices You Should Be Doing Now

5 January, 2017 Cindy Fazzi, Staff Writer

Let’s play a quick word association game. If I say CAPA, I’m betting someone will say manufacturing. The concept of corrective action and preventative action is indeed associated with product quality in manufacturing because of long-standing regulations and standards requiring CAPA in that sector. However, MasterControl’s Patricia Santos-Serrao says you can and should leverage CAPA principles in clinical research.
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