Multimedia Library

on 'cGMPs'

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  • INTERPHEX 2012: Alkermes Expands Its Core Capabilities and Emphasizes Compliance

    At Interphex 2012, Jim Botkin, Senior VP of Operations for Alkermes plc, discusses the extent of his organization's services and capabilities following the recent merger with Elan Drug Technologies. Botkin also discusses the importance of risk-based compliance to the success of any contract partnership. "GMP is good business," he says.

  • April Webcast Series on cGMP Compliance and Data Integrity

    Hear from the legal team that represented whistleblower Cheryl Eckard (Lesley Ann Skillen and Neil Getnick) and from qui tam expert Ken Nolan of Nolan and Auerbach on how to prevent legal liability and what employees need to know before considering whether to blow the whistle on noncompliant practices.

  • Good Engineering Practice in a QbD Time

    ISPE’s new baseline guide for Good Engineering Practice has just been released, and NNE Pharmaplan’s Peter Christiansen outlines key new concepts.

  • Bio in Brazil: Positioned for Growth

    Biominas Foundation CEO, Eduardo Soares discusses how Brazil is prepping for growth in BIO and looking for guidance from other regulatory agencies.

  • A World Beyond ICH: WHO, ISO Must Figure Prominently in Harmonization

    Regulatory harmonization has made great strides, but if efforts are to become truly global the World Health Organization must be involved. In this audio interview, Birgitte Holst, Manager of Manufacturing Science & Quality at Novo Nordisk, discusses pharmacopeia, terminology, anticounterfeiting, and more.

  • Automated EH&S: Move Away from Paper

    The right software can help manufacturers save time and money, and improve environmental health. Dan Gallagher of Cork, Ireland's EHA Soft discusses the challenges of maintaining environmental health and safety compliance with Senior Digital Editor Michele Vaccarello Wagner.

  • Video: AZ’s Brennan on Manufacturing as a Core Competency

    AstraZeneca raised some eyebrows a few years ago when executives suggested that the company would outsource most of its manufacturing operations. In this interview, CEO David Brennan clarifies this perception: It’s all about recognizing your core competencies, he says, and for AZ that means biologics and late-stage small molecule production. For “commodity” operations, outsourcing makes perfect sense, he says.

  • To Outsource or Not—Is Your Culture Ready?

    When deciding whether or not to outsource, manufacturers must strip decision factors down to a basic few: Is there a business case to justify the risk? Will the outsourcing free you up to focus more on your core competencies? And finally, is your culture ready for outsourcing? This video is the start of a series with outsourcing expert Rakesh Kishan, CEO of UMS Advisory, Inc., about the need for pharmaceutical manufacturers to see outsourcing in a new light—as an opportunity to focus operations and empower employees.

  • Certified Pharmaceutical GMP Professional

    The American Society for Quality is introducing a testing and certification program for professionals who have five or more years of industry experience. Here to explain more about the program and its genesis is Robert Seltzer, a pharmaceutical quality executive with a leading drug company and a senior member of ASQ.

  • “PAT Talk”: The Pharma Quality Lifeline

    Pharma Quality is being redefined by ICH, linking quality to process efficiency. Now it must carry the industry into the era of personalized medicine. Tune in to Emil Ciurczak and Jack Carroll for some straight talk on benchmarking and legacies from Deming et al.

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