• Supplier Quality Agreements: Benefits to You and Your Supplier

    10 May, 2012 Betty Lane, Founder and President, Be Quality Associates, LLC

    Note: The views expressed in this article are those of the author and do not necessarily represent those of his/her employer, GxP Lifeline, its editor or MasterControl, Inc."

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  • Drug Accountability in Clinical Trials

    3 May, 2012 Dr. Robbie Wong, Pharm.D., Clinical Development Consultant and Affiliate Assistant Professor, Dept. of BioEngineering, University of Washington

    It's not exciting, it's not cutting edge. It may be the last thing you think about when preparing for an FDA audit. You might scan the records and figure if all the lines are filled in, it must be okay. Or, the auditor might not look at it, so I will trust that the pharmacist did it correctly. After all, aren't pharmacists one of the most trusted professions? Consider this: if drug accountability is in question, then the whole study could be in jeopardy. Proving that the drug was administered to the patient that resulted in the effects seen from study drug is a key factor in determining the merit of a product candidate. The FDA has listed drug accountability as number three in a list of top five pitfalls.

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  • Risk-Based Approach to Monitoring: The Value of Data in Clinical Studies

    3 May, 2012 Patricia Santos-Serrao, Senior Product Manager, Pharmaceutical Industry, MasterControl, Inc.

    In August 2011 the Food and Drug Administration (FDA) released a guidance entitled "Oversight of Clinical Investigations - A Risk-Based Approach to Monitoring," which highlights a new approach to clinical site monitoring different from that of years ago. In this most recent guidance, the FDA openly states that "Many sponsors have understood that FDA expects sponsors to conduct frequent on-site monitoring and 100% data verification for all trials," clarifying that this is not always the best approach or the most productive use of time.

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  • Implementing a Systems Approach to Parmaceutical Quality Systems

    22 April, 2012 Christine Park, Quality Architech, Christine Park & Associates

    In 2002, the Food and Drug Administration (FDA) announced an initiative to integrate quality systems and risk management approaches into existing regulations for pharmaceutical manufacturing. While the FDA hasn't changed the 21 Code of Federal Regulations (CFR) Parts 210 and/or 211 regulations, they have published industry guidance, Quality Systems Approach to Pharmaceutical CGMP Regulations.

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  • One Year Later: The FSMA and the Food and Beverage Industry

    18 April, 2012 Cindy Fazzi, Marketing Communications Specialist, MasterControl, Inc.

    A year has passed since the Food Safety Modernization Act (FSMA) was signed into law. Some of the changes envisioned under the FSMA are already in place, such as the FDA's new mandatory food-recall authority and the authority to detain food products that the agency has reason to believe are adulterated or misbranded.

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  • The European Qualified Person - What's It All About?

    17 April, 2012 Wolfgang Schmitt, Director Operations, CONCEPT HEIDELBERG GmbH

    Note: The views expressed in this article are those of the author and do not necessarily represent those of the employer, GxP Lifeline, its editor or MasterControl Inc.

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  • Annex 11: The EU's New Expectations for Regulated Computerized Systems

    10 April, 2012 Martin Browning, President and Co-Founder, EduQuest

    Note: The views expressed in this article are those of the author and do not necessarily represent those of his/her employer, GxP Lifeline, its editor or MasterControl, Inc.

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  • How Life Science Companies Can Leverage Mobile Technology

    10 April, 2012 Cindy Fazzi, Marketing Communications Specialist, MasterControl, Inc.

    Mobile technology has come a long way. Smartphones and tablets are getting better, smaller, and less expensive. It is no wonder that almost everyone has one.

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  • What to Expect When They're Inspecting - Part II

    10 April, 2012 Holly Scott, Biologics Consulting Group, Senior Consultant and Former CBER Consumer Safety Officer and FDA Field Investigator

    Note: The views expressed in this article are those of the author and do not necessarily represent those of his/her employer, GxP Lifeline, its editor or MasterControl, Inc.

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  • Employing Audits for Improved Supplier Performance

    3 April, 2012 Bob Mehta, GMP ISO Expert Services

    Note: The views expressed in this article are those of the author and do not necessarily represent those of his employer, GxP Lifeline, its editor or MasterControl Inc.

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  • Surviving the Hosted Compliance Audit: Front Line, Back Room and in the Shop

    30 March, 2012 MasterControl

    Compliance audits present their own orientation to an organization that wants to present the perfect front while being asked to air their dirty laundry. Is this inspection about smoke and mirrors or does the audited facility present a "zipped-tight" posture toward the investigator?

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  • eMDR Conversion and Implementation - Part II

    27 March, 2012 Eugene Reilly, FDA's Center for Devices and Radiological Health

    Note: The views expressed in this article are those of the author and do not necessarily represent those of his/her employer, GxP Lifeline, its editor or MasterControl, Inc.

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  • FDA Issues Draft Guidance on Biosimilar Product Development

    22 March, 2012 PharmaManufacturing.com

    The views expressed in this article are those of the author and do not necessarily represent those of his/her employer, GxP Lifeline, its editor or MasterControl, Inc.

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  • Clinical CAPA: CAPA Isn't Just for Manufacturing Anymore

    22 March, 2012 Patricia Santos-Serrao, Senior Product Manager, Pharmaceutical Industry, MasterControl, Inc.

    Note: The views expressed in this article are those of the author and do not necessarily represent those of her employer, GxP Lifeline, its editor or MasterControl, Inc.

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  • Outsourcing Trends for 2012

    22 March, 2012 by Kate Hammeke

    With the goal of optimizing collaborations in the drug development industry, Nice Insight (http://niceinsight.com/) developed a quarterly survey to measure customer awareness and customer perception across 300+ contract research and manufacturers. Nice Insight's Q4 Pharmaceutical and Biotechnology Outsourcing Survey generated responses from 2,619 outsourcing-facing executives from big pharma (29%), specialty pharma (17%), emerging/niche/start-up pharma (22%), biotechnology (25%), and emerging biotechnology (7%). In addition to creating a research tool that aids sponsors in the outsourcing partner selection process and enabling CROs and CMOs to understand their position within the industry, Nice Insight also garners broad industry trends from its survey data.

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  • The Odd Couple - Quality vs. Research

    29 February, 2012 Patricia Santos-Serrao, Senior Product Manager, Pharmaceutical Industry, MasterControl, Inc.

    Compliance is often seen as a subjective word, and at best can mean something very different from one functional area to another within the same organization. The compliance requirements for a quality group are very different from those in R&D groups such as Clinical and Regulatory Affairs. Technology and processes can play a significant role in defining and meeting compliance requirements, however if the technology is not flexible and configurable it can become difficult to implement one solu

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  • eMDR Conversion and Implementation - Part I

    29 February, 2012 Eugene Reilly, FDA's Center for Devices and Radiological Health

    Note: The views expressed in this article are those of the author and do not necessarily represent those of his/her employer, GxP Lifeline, its editor or MasterControl, Inc.

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  • The 'Supply Chain' Patient is Sick

    21 February, 2012 Hedley Rees, Biotech PharmaFlow

    Hedley Rees looks at the problems with the pharmaceutical supply chain and questions whether they can be resolved.

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  • The Rising Costs of Clinical Trials

    31 January, 2012 Patricia Santos-Serrao, Senior Product Manager, Pharmaceutical Industry, MasterControl

    One of the most costly areas of business for any Pharmaceutical or Biotechnology Company has always been clinical research. Now more than ever the cost of bringing a product to market is staggering and as patents on trademark products expire the hope for recovering costs of research get smaller and smaller.

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  • Writing and Enforcing Your SOPs for GxP Compliance Success - for Life Science Professionals

    31 January, 2012 David R. Dills, Quality & Compliance Advisor

    Writing and developing solid operational procedures is a skill that develops over time. Procedures are usually fairly technical and often describe complex subjects. These procedures are reviewed by subject-matter experts, as well as by internal and external auditors and by employees at all levels of the organization. Therefore, it is important to consider the language used when communicating an idea.

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