Showing items tagged as Blood & Biologics

  • 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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  • Is Compliance an Obstacle to Quality?

    15 September, 2016 Daniel Matlis, Founder and President, Axendi

    Can you distribute poor quality products while complying with regulatory requirements? Sure, after all, you can conduct a recall of poor quality products in compliance with all applicable regulations.

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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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  • Ignoring This Overlooked Risk Management Metric Leads You Down The Path To The Dark Side

    13 October, 2016 by Ed Rusch, Vice President, Corporate Marketing, Elemica

    Hurricanes. Power outages. Socio - geopolitical upheavals. Train derailment. Road closures. Contamination in a supplier facility. Terrorism, cyber-attack, sabotage or industrial espionage. Labor unrest. Global pandemic. Fires, floods and natural disasters. These incidents are not a work of science fiction and the number of them that can negatively affect the supply chain are real and virtually limitless.

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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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  • 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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  • Key Regulations & Initiatives that Modernized Compliance for Life Science Companies

    4 October, 2016 by Cindy Fazzi, Editor, MasterControl Insider

    Not too long ago, regulatory compliance meant color-coded stamps for various documents, gigantic cabinets for storing files, and truckloads of paper documents for FDA submissions. The advent of 21 CFR Part 11 signaled the movement toward automation. It’s one of 16 regulations and initiatives that helped modernize the compliance process for life science companies.

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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 Things I Learned about FDA Audits from its Sister in Compliance, the FCC

    10 January, 2017 Anthony Rossi, Sales Operations Specialist, MasterControl

    Before I came to work at MasterControl, I was an operations coordinator at a company called CaptionCall. CaptionCall provided telephone captioning to the hard of hearing, and because it was funded through federal taxes we were directly overseen by the FCC. While I was working at CaptionCall, I was directly involved in an audit performed by the FCC. The day of the inspection was one of the most stressful days in my career.

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  • Surviving Live Data Inspections by the FDA---3 Critical Success Factors

    19 January, 2017 B. Christine Park, CQA, CQM/OE Consultant

    I have long been a supporter of being well prepared for FDA inspections, including how data is presented during the inspection. Historically, you’d print the files for FDA review rather than do a live demonstration of the database information. While I haven’t experienced it yet, it is my understanding that the FDA is now requesting a “live” data review. Essentially the expectation is for you to walk the inspector through your files and explain the information rather than have you print and organize paper files before they see it.

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  • How to Lead with Respect

    7 February, 2017 Mike Orzen, Founder, Mike Orzen & Associates

    “Over time I’ve come to realize that engaging in this problem-solving process is actually the highest form of respect….The manager truly respects the employee’s knowledge and his or her dedication to finding the best answer….Only by showing mutual respect-- each for the other and for each other’s role-- is it possible to solve problems, make work more satisfying, and move organizational performance to an ever-higher level.”

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  • ISO, Regulatory Requirement Changes Loom

    1 September, 2017 by B. Christine Park, Consultant, Christine Park & Associates

    As we near the end of the first quarter of the new year, it’s time for everyone to get really serious with transition plans to the new ISO quality management systems standards and other regulatory requirement changes.  Here are a few of the recent changes:

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  • Quality Pros & the Oscars: Films to See Based on Your Personality

    16 February, 2017 Cindy Fazzi, Staff Writer, MasterControl

    It’s Oscar season! From Seattle to Shanghai, movie fans are talking about their favorites, and maybe betting in their Academy Award office pool or its equivalent overseas. Watching Hollywood films is the world’s favorite pastime, judging by the U.S. film industry’s box-office revenues, which exceeded $11 billion in 2016 (1).

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  • EU Policy 70 and Redaction — PleaseReview’s Take on It

    1 September, 2017 by David Cornwell, Founder/CEO, PleaseTech Ltd.

    This blog post is primarily about how PleaseReview can assist life science companies in the process of complying with the European Medicines Agency (EMA) transparency policy 70 on the publication of clinical data. However, it also discusses how we at PleaseTech plan to expand PleaseReview’s redaction (or masking as it is sometimes known) capability over the next six months, so this post may be of interest to those readers with other redaction challenges.

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  • The Migraine Known as the Supplier Audit — and Some Simple Remedies

    23 February, 2017 Ken Christie, COO, VTS Consultants

    The topic of supplier audits can cause severe anxiety and headaches for many biopharma companies. This pain stems from the combination of having to understand the applicable regulations, determine the elements of a supplier audit in terms of criticality, establish the frequency and type of audits to be performed based on this evaluation, and follow-up on any issues found. Sufficient time is needed to prepare for and execute such activities, and time is one thing few of us have enough of. However

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  • FDA Eager to be Innovative Partner with Expedited Access Pathway

    16 March, 2017 David Jensen, Staff Writer, MasterControl

    Part of FDA’s prime directive is to assure the safety, effectiveness and quality of biological products and medical devices. So the notion of FDA endorsing the acceleration of product development might raise some eyebrows. However, FDA officials and industry experts alike seem to agree that with some patients waiting is not the hardest part, it’s actually not an option.

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  • How to Practice Quality Management in Your Personal Life

    4 April, 2017 Paul Sanderson, Solutions Consultants Manager, MasterControl

    “Quality management” is one of those terms that sounds so simple and esoteric at the same time, like DNA or free cash flow. I’m pretty sure I know what those terms mean until I start explaining them to someone. 

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  • 20 Years Later, 21 CFR Part 11 is More Relevant than Ever

    24 April, 2017 Cindy Fazzi, Staff Writer, MasterControl

    If 21 CFR Part 11 and the life science industry were a married couple, they would be celebrating their platinum wedding anniversary this year. For better or for worse, in sickness and in health, it has been 20 years of compliance. It’s an important milestone to celebrate and think about.

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