Showing items tagged as Blood & Biologics

  • 2018’s Top Clinical Pharma/Bio Trends to Date

    20 June, 2018 by James Jardine, Staff Writer, MasterControl

    Economic, technological, policy and scientific changes occur so frequently in the hypercompetitive pharmaceutical and biologics sectors that only the most versatile and far-sighted companies can thrive. Get the inside scoop on the top five clinical trends experts believe will be the difference between success or failure for pharma/bio organizations.

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  • Australia Offers Wave of Potential for Pharma, Medical Device Manufacturers

    13 June, 2018 by Mike Rigert, Staff Writer, MasterControl

    Australasia is quickly becoming a hotbed for life sector manufacturers including pharmaceutial and medical device companies from around the globe seeking regulatory approval for their products and other opportunities. Find out why.

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  • Biosimilars: A Safe and Effective Option for Patients

    8 March, 2018 by Christine Simmon, Executive Director of the Biosimilars Council, a division of the Association for Accessible Medicines

    It is a difficult irony that even as medical breakthroughs and new life-saving and life-extending treatments bring hope to patients and families across the country, it also is getting harder for many to afford these critical medicines. The rapidly rising cost of brand-name biologic medicines, which comprise the vast majority of new therapies in the pipeline, mean they are often inaccessible for America’s patients.

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  • February Tip: Continuous Employee Training Reduces Deviations and Nonconformances

    9 February, 2018 by Jake Walton, Corporate Operations Quality Manager, MasterControl

    This blog post is part of an ongoing series to provide the latest tips from experts in the field to help readers keep up with changes in the quality and regulatory industry .

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  • What Do Changes to Australia’s PIC/S Guide to GMP Mean for Pharma Down Under?

    1 February, 2018 by Luana Carone, Solutions Consultant for Australia/New Zealand, MasterControl

    It’s said that change is never easy. But in the pharmaceutical industry, flexibility, and adaptability are part and parcel of successfully delivering the safest, highest quality products to a global market.

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  • January Tip: How to Choose and Use External Consultants

    23 January, 2018 by Jake Walton, Quality Manager

    External consulting firms can be used to provide expert help for many of the standard responsibilities that the quality department is tasked with. These external organizations are ready to provide you with the necessary documents to get on your approved supplier list, and can jump into work at various stages. Look for organizations that have specialized experience in the area(s) you are looking for and they can quickly and effectively help.

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  • Don’t Let These Product Registration Problems Delay Your Time to Market

    7 November, 2017 by Cindy Fazzi, Staff Writer, MasterControl

    The combination of a lengthy process and high cost of drug development is a hard pill to swallow for pharmaceutical companies. It should serve as the biggest motivation for them to find fundamental ways to accelerate their overall time to market.

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  • Revisiting CAPA for a More Modern (and Effective) Approach

    17 October, 2017 by Peter Knauer, Managing Partner, Sage BioPartners

    Corrective action and preventive action (CAPA) policies and procedures have now been a mainstay for years in most life science companies’ quality management systems due to regulation adherence to standards. With impressive technological advances, it is natural that companies are starting to develop products that span multiple sectors, and even multiple regulatory pathways. The question is, what standard/regulation do you use for your CAPA system and how do you cover all the others?

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  • Three Ways to Accelerate Your Lean Journey

    4 October, 2017 by Dan Markovitz, Founder, Markovitz Consulting

    I spent two days in St. Louis last week at the Global Lean Leadership Conference. It’s a small conference—only about 150 people—consisting of companies that have embraced Paul Akers’s 2 Second Lean philosophy. Companies that wanted to join the conference were required to have the president attend (although there were many other people from those companies as well).

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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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  • 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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  • Good Communication Skills are Key for Inspection Readiness

    25 August, 2017 by UL

    When an FDA inspector comes to your door, it is usually a time of stress and uncertainty.  You need to handle logistical elements like where the inspectors are going to be placed, how you 

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  • Avoiding CAPA Pitfalls: 10 Tips from a Food Industry Quality Expert

    22 August, 2017 by James Jardine, Staff Writer, MasterControl

    At a recent ASQ Salt Lake Section symposium held at the headquarters of quality management software solutions provider

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  • Not Just Tiny Humans: Considerations for Conducting Pediatric Clinical Trials

    25 July, 2017 by Jamie Arnott, Project Director and Caitlin Hirschman, Clinical Team Lead, Rho

    When it comes to the conduct of pediatric clinical trials, there are number of things you need to consider in order to ensure the successful conduct of a study. From study design to logistics to recruitment, there are real differences between studies conducted in pediatric populations and studies conducted in adult populations.

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  • How Training Personnel on Your Quality System Can Produce Positive ROI. Don’t Stop at the Quality Manager.

    18 July, 2017 By Greg Peckford, Founder, Quality Career Advancement

    Is the quality manager the only individual within an organization that requires training on quality and improvement methods? Absolutely not! In order for an organization to get the most value out of their quality program, and to ensure it is effective, is to train as many people as possible or even all employees, depending on the size of the company, on the concepts and strategies that its quality management system is based on.

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  • Developing a Quality System on a Managed Budget

    11 July, 2017 by Keith Matthews, Director Quality Systems, Regulatory Compliance Associates Inc.

    Developing a quality system is the foundation for ensuring the organization’s products or services are safe, effective and controlled to deliver customer satisfaction.  Throughout the organization’s lifecycle, from start-up through maturity, the quality needs of the firm, along with its budget constraints, are continually evolving.  Maintaining compliance with regulations while controlling costs represents a challenging balancing act we encounter in our life science consultancy. 

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  • Why the Supply Chain Is so Important Toward Supporting Business Success

    6 July, 2017 by Bob Ferrari, Managing Director, The Ferrari Consulting and Research Group, Founder and Executive Editor, Supply Chain Matters blog

    I term myself as an observer of multi-industry supply chains from respective management practitioner, technology implementer and industry analyst roles. I founded the

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  • An Exciting Time in Life Sciences: Touching Stories from a Life-Improving Industry

    29 June, 2017 by Marci Crane, Staff Writer, MasterControl

    A recent industry outlook for the life sciences industry published by Deloitte mentions opportunities and concerns facing the life sciences industry.

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  • Combination Products and CGMPs: What You Should Know

    27 June, 2017 by Dr. Karl M. Kapp, Department of Instructional Technology, Bloomsburg University

     At the beginning of this year, the FDA    issued final guidance for Current Good  Manufacturing Practice (CGMPs)  Requirements for Combination Products.  This guidance is for therapeutic and  diagnostic products that combine drugs,  devices, and/or biological products. This  guidance has become increasingly  necessary due to the rapid pace of technological advances in the life science industry where product types continue to merge and blur lines

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  • Training Does Not Stand Alone: The Quest for Training Effectiveness Continues

    8 June, 2017 by Vivian Bringslimark, President and Owner, HPIS Consulting, Inc.

    While training may appear to be straightforward to most leaders, the effectiveness follow up is anything but clear-cut. So why do business leaders frown when the answer to the training effectiveness question is – it depends?

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