GxP Lifeline

Showing items tagged as Pharma

SOP Revision SWAT-Style

19 May, 2016 Laurie Meehan, Social Media Manager, Polaris Compliance Consultants, Inc.

SOP revision. It falls somewhere between income tax prep and colonoscopy prep on the likability scale. So why would you want to read about it? Maybe you’re hoping someone’s figured out a way to make the process more efficient and less painful. Maybe we have.
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Five Reasons Why TMF Training is Important

17 May, 2016 Sholeh Ehdaivand, President and CEO, LMK Clinical Research Consulting

Training is a vital component of workplace efficiency especially when it comes to one of the most important deliverables of a clinical trial – the Trial Master File (TMF). Perhaps that’s why, according to a recent article in Forbes magazine, U.S. companies spent over $70 billion on corporate training in 2014, an increase of 15% over the previous year. If you are lucky enough to oversee the TMF, you spend so much time bringing the right employees on board, it only makes sense you would understand the importance of providing them with the proper training to ensure your TMF is always inspection ready.
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Cleanroom Compliance: How to Address Common Challenges in Document Control

5 May, 2016 Dave Hunter, Product Management Director, MasterControl

A recent warning letter to a medical device firm shows the importance of proper documentation of cleanroom maintenance procedures and corresponding control of those documents. The FDA noted the company’s failure to establish and maintain written procedures for avoiding contamination of equipment, as well as the incongruity between some of its cleanroom procedures and records of actual practice (1).
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Don’t Trip over These 9 Document Control Pitfalls

26 April, 2016 Dave Hunter, Product Management Director, MasterControl

Document control issues are among the most commonly cited observations in FDA Form 483s and warning letters. In the medical device sector alone, document control-related issues represented 10 percent of Form 483 observations and 8 percent of warning letters in 2014(1).
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Income Tax Myths and Document Control Systems

5 April, 2016 Robyn Barnes, Marketing Communications, MasterControl

I’ve been reading Steve Berry’s novel, “The Patriot Threat.” The crux of the book is that the 16th Amendment to the Constitution, the one that requires Americans to pay income tax, may be illegal. The story goes that some of the states may have never ratified the Amendment, and some may have ratified a document that didn’t have the same wording as others. (I won’t spoil the mystery by telling you what transpires.)
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ISO 9001:2015 - A Powerful Addition to Your Professional Tool Kit

29 March, 2016 Greg Peckford Founder, Quality Career Advancement

There are over one million organizations in over 170 countries registered to ISO 9001. That alone is a pretty impressive statistic claimed by www.iso.org. But what this stat is missing are the countless other companies worldwide that have adopted the ISO 9001 standard as a blueprint for the development and implementation of their quality management systems without becoming formally certified.
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Why We Trek to Trade Shows

14 March, 2016 Jill Bumgardner, Global Events Manager, MasterControl

Most people generally support the notion that trade shows are still relevant, but sometimes a little pep talk is in order.
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Leveraging Quality Management Systems to Visualize and Mitigate Risk at a Cross-Enterprise Level

11 March, 2016 Robyn Barnes, Marketing Communications, MasterControl

You may be familiar with what a quality management system (QMS) is, but do you know how to use one at a cross-enterprise level?
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How to Explain Your Quality Job to Young Kids in 4 Steps

10 March, 2016 Lillian Erickson, Global Quality Manager, MasterControl Inc.

When it was time to celebrate Career Day at my daughter’s school, she begged me to come talk to her first-grade class. I dreaded it. How do you explain to 6- and 7-year-olds what a quality manager does?
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When Is A CRO Not A CRO? (And why does that make enforcement hard?)

11 February, 2016 amie Colgin, Colgin Consulting

Investigator site personnel recorded observations about clinical trial subjects in paper medical charts. Lab work was performed and interpreted at a local lab; X-rays and ECGs were taken and interpreted locally; and results were sent back to the investigator.
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One Q & a Lotta A’s about SOPs for Research Sites

2 February, 2016 Laurie Meehan, Social Media Manager, Polaris Compliance Consultants, Inc.

“What are your thoughts about having SOPs for clinical research sites versus having working guidelines in lieu of SOPs?”
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People Don’t Fail, Processes Do

28 January, 2016 Terry Smith, Lean Enterprise Institute

Lean isn’t only a mindset. It gives you and your organization tons of tools and techniques you can apply immediately to improve your business processes. One of my favorites is the 5 Whys. It’s the best demonstration I think of how in fact, people don’t fail, processes do.
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How to Respond to FDA Inspection Observations, Including Those You Dispute

26 January, 2016 Martin Browning, President, EduQuest, Inc.: FDA expert investigator and rule-maker for 22 years

Although FDA is strapped with limited resources and competing priorities, the Agency continues to hammer regulated companies with FDA 483 inspection observations and Warning Letters.
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Big Changes for ICH GCP & EU Regulations

31 December, 2015 Laurie Meehan, Social Media Manager, Polaris Compliance Consultants

The most substantial change to international guidelines in 20 years occurred earlier this year when the ICH* issued a draft addendum to its GCP guidelines, ICH E6(R2).
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A Season for Giving That Lasts All Year

23 December, 2015 Beth Pedersen, Marketing Communications Specialist, MasterControl

We all feel it this time of year. As temperatures drop and snowflakes swirl, lights and festive decorations illuminate the long, dark nights, and names are diligently checked off seemingly endless shopping lists, we know that the holiday season is upon us. In spite of the stress that can accompany the holidays – the long lines, the gift wrapping, the social obligations – this time of year marks a widespread urge to give: to family, to friends, even to those we’ve never even met. We all feel it, this intangible, albeit very real, spirit of giving.
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Using Quality by Design to Improve Manufacturing

22 December, 2015 Ronald D. Snee, PhD Snee Associates, LLC

Much of the literature on quality by design (QbD) has focused on the creation of the “Design Space” (ICH 2009) which is the combination of levels of the critical process parameters that produces in-specification product. Design space creation is critical but a process control strategy is also essential and is an integral part of QbD. Stage 3 of the FDA Process Validation Guidance calls for “Continued Process Verification” (CPV), or continually verifying the process is doing what it is supposed to do throughout the life of the product (FDA 2011, Snee 2015). Also if we are to be effective in using life cycle management to manage the process over time. we must have a process management system in place that integrates both process control and process improvement (Snee and Gardner 2008, Snee 2010b).
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Inspection Readiness: Leveraging Inspection Focus Areas and Increasing the Transparency of Investigator Oversight

1 December, 2015 Jessica Masarek, Quality Assurance Consultant | Independent Auditor Director, Muse Clinical

Audits and inspections seem to be wrapped in a shroud of mystery, making folks stressed and unsure of exactly what is going to happen. What if I say the wrong thing? What if I don’t know the answer? What if I can’t provide what they are asking for? Realistically, all of these things will probably happen! That said, as long as you are honest, all will be well. Mistakes happen and no auditor or inspector is expecting perfection. We are expecting transparency. As an auditor, my goal is to confirm that the trial is run in a way that ensures the safety of subjects, protects their rights, and generates reliable data. Sponsors want to continue working with sites in which so much effort has been invested and will work to identify areas for improvement if deficiencies are noted. An inspector has a similar goal with respect to the assessment of trial conduct. So, how do we ensure that trials are run at the level of quality that regulators are looking for and that are truly inspection ready?
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9 Crazy Cousins You Probably Shouldn’t Invite to This Year’s Thanksgiving Dinner and 9 Reasons You Could Invite SCORM (Compliance) Instead

19 November, 2015 Marci Crane, Localization Manager, MasterControl

Thanksgiving in the USA is a wonderful time of year when we are reminded of everything that we have and how lucky we are to have it. We express our gratitude for what we have, where we live and those we love.
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eTMF Management: Don’t Settle for a One-Trick Pony!

12 November, 2015 Patricia Santos-Serrao, MasterControl's Market Segment Manager, Global Pharmaceutical, Blood & Biologics

Organizations searching for an electronic trial master file (eTMF) solution are likely to stumble upon various vendors claiming to be the “industry leader in eTMF” or some variation of this statement. With so many vendors claiming to be leaders, what does that mean to be a leader in eTMF? Should it factor into my decision as I evaluate and choose a solution for my organization? The answers to that question may not be a clear cut as one may think.
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Why Every Business Needs to Make ISO Certification a Priority in 2015/2016

10 November, 2015 Stuart Patch, Content Writer, Compass Assurance Services; info@compassassurance.com.au

There are many benefits for organisations gaining certification and for those organisations that are currently certified, ensuring those benefits continue to be realised is very important. Below I look at the benefits of certification and also what are the benefits of keeping abreast of upcoming changes in standards.
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