GxP Lifeline

 

  • A Guide to Pharmaceutical Quality by Design

    16 May, 2019 by Beth Pedersen, Staff Writer, MasterControl

    Quality by Design (QbD) continues to be a hot topic across the life sciences industries. As more of the pharma sector implements pharmaceutical QbD, regulatory bodies work to further develop a common understanding of key concepts, terminology and expectations.

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  • 3D Printing of Pharma Dosage Forms a Promising New Tech for Discovery

    30 April, 2019 by Jae D. Yoo, PhD, MBA, Chief Technology Officer, Aprecia Pharmaceuticals

    Pharmaceutical manufacturers depend on innovation and new technologies to find new cost-effective ways of speeding up the drug development process. 3D printing (3DP) allows greater flexibility during the discovery process through rapid prototyping formulations and the potential for on-demand production of clinical samples. Learn how 3DP may change the way pharma does business.

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  • Achieve Greater Operational Compliance and Efficiencies in Pharma Through IDMP Implementation

    30 April, 2019 by Frits Stulp, Managing Director, Iperion Life Sciences Consultancy

    The Identification of Medicinal Products (IDMP) is a set of ISO data standards that will help ensure that pharma organizations around the world speak the same language when it comes to product information and definitions. Find out how IDMP can also help improve your company’s internal quality processes.

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  • EBR: Good for What Ails Your Batch Record Process

    21 February, 2019 by Beth Pedersen, Staff Writer, MasterControl

    Let’s face it, winter is a euphemism for cold and flu season. Much like these inconvenient and disruptive viral infections wreak havoc on the human body, paper-based batch record processes can infect a manufacturing floor, slowing and compromising an otherwise healthy operation. Fortunately, an electronic batch record (EBR) solution can cure the disease.

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  • Need Help With Vendor Selection? Don’t Pick Up the Phone Until You Answer 3 Simple Questions

    8 January, 2019 by Ray Sison, VP of Pharmaceutical Outsourcing and Tech Transfer, xCell Strategic Consulting

    Vendor selection in pharmaceutical manufacturing and related life sciences sectors is never an easy process. But incorporating comprehensive SOPs that answer three key questions can make for much smoother discussions during the selection process and contract negotiations.

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  • The Importance of Knowing What You Don’t Know About Drug Development

    4 December, 2018 by Arvilla Trag, RAC, Consultant, BioProcess Technology

    New drug development is Sunday drive, especially for startups. There can be costly mistakes and unanticipated roadblocks that pop up when you least expect it. Learn how to steer clear of hazards, what to do and who to talk to.

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  • What's Hiding in Your Labeling Artwork?

    23 October, 2018 by Dan Vuksanovich, Regional Sales Manager, Schlafender Hase

    Because there are potential but invisible risks inherent in labeling artwork documents of life science companies that can’t be detected through manual proofreading, it’s important to be thorough and to know the tricks to detect and prevent these snags from causing unnecessary delays in the manufacturing process.

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  • Beyond the Mandates: The Business Value of Mass Serialization and Supply Process Visibility, Part 2

    15 August, 2018 by Carla Frances Reed, President, New Creed

    A look at how how global mandates for implementing mass serialization within supply chain management are coming to fruition in U.S. and European markets, just to name a couple, and how the use of technology can help supply chain managers get a better handle on this task through automated, real-time visibility.

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  • Artificial Intelligence: Is It on the Cusp of Revolutionizing Pharmaceuticals?

    21 August, 2018 by Mike Rigert, Staff Writer, MasterControl

    One of the major technological trends beginning to impact the pharmaceutical industry is artificial intelligence (AI). Analysts say it isn’t a matter of if but when AI will become a game-changer for pharma companies, particularly when it comes to slashing the time and costs involved with drug discovery. Find out what your company can do to best plan for AI’s anticipated revolutionary impact on drug development.

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  • Best Practices for Supplier Evaluation and Rationalization

    26 July, 2018 by Carla Frances Reed, President, New Creed

    Pharmaceutical companies continuing the trend of mergers, acquisition and partnerships is creating challenges, opportunities and redundancies for supplier management. To meet these changing needs, it’s imperative that managers conduct supplier evaluation and rationalization processes and emphasize “good supply practices.” Learn some of these best practices and how to adapt them to your company.

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  • Regulatory Barriers to Innovation for Startups

    31 July, 2018 by Tifany Desprez, Ph.D., Communication and Marketing Manager with MasterControl European Partner, Apsalys

    France and Europe are witnessing an explosion of life science innovation from new startups. But what separates the winners from the losers? Learn how to successfully overcome regulatory barriers and get your product to market quicker.

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  • How AI Tools Will Transform Quality Management in the Life Sciences, Part 2

    12 July, 2018 by Jerry Chapman, GMP Consultant and Editor-in-chief, Xavier Health

    The second part of a two-part blog post that examines the importance of the emerging technology of artificial intelligence and the potential is has to bring about a massive shift in quality management for pharma and medical device manufacturers. Xavier Health takes a closer look on how to prepare and assess the readiness of your company to implement AI.

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  • How AI Tools Will Transform Quality Management in the Life Sciences, Part 1

    10 July, 2018 by Jerry Chapman, GMP Consultant and Editor-in-chief, Xavier Health

    FDA officials believe that artificial intelligence (AI) has the potential to bring about a step change in quality management in the pharma and medical device industries. Xavier Health has assembled a team of multidisciplinary experts to take a closer at the possibilities and roadblocks AI presents to quality management in both industries. Part 1 of a two-part series.

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  • What Biotech Startups Need to Do to Slay the Competition

    21 June, 2018 by Matthew M. Lowe, Executive Vice President of MasterControl

    Venture capitalists have pumped $2.8 billion into biotechnology startups in the first two months of this year alone. This means two things if you’re a startup. First, expect fierce competition because a huge capital pool attracts the very best in the industry. Second, this kind of investor confidence requires that you hit the ground running.

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  • 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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  • FDA Backs Cannabis-Based Drug to Treat Kids With Epilepsy

    5 June, 2018 by Marci Crane, Staff Writer, MasterControl

    Is the U.S. FDA about to approve the first cannabis-derived drug to win federal approval? In a recent FDA Advisory Committee meeting, a teenage boy addressed committee members. Sam, an epilepsy patient, was the first U.S. citizen to try Epidiolex, a cannabis-derived drug. Read about the future of medical marijuana.

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  • FDA Experts Give Top 10 FDA GMP Inspection Citations for FY 2017, Part 2

    24 May, 2018 by Jerry Chapman, Editor-in-chief, Xavier Health, and GMP Quality Consultant

    Experts at the FDA/Xavier PharmLink conference at Xavier University in March 2018 presented and analyzed the FDA's top 10 drug GMP inspection citations for FY2017 during a panel discussion. The second part of a two-part series.

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  • FDA Experts Give Top 10 FDA GMP Inspection Citations for FY 2017, Part 1

    22 May, 2018 by Jerry Chapman, Editor-in-chief, Xavier Health, and GMP Quality Consultant

    Experts at the FDA/Xavier PharmLink conference at Xavier University in March 2018 presented and analyzed the FDA's top 10 drug GMP inspection citations for FY2017 during a panel discussion. The first part of a two-part series.

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  • Strategic Design of the Supply Chain: Too Little, Too Late for Pharma?

    24 April, 2018 by Hedley Rees, Managing Consultant, PharmaFlow

    Prevent your supply chain from becoming neglected by strategically designing each link in the chain. The key to a successful supply chain isn't focusing on the endpoint but rather bolstering each location along the way.

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