Showing items tagged as Quality and Compliance

  • Collaboration is More Than Just a Buzzword in Regulated Environments

    10 February, 2014 Marty Jackson, Professional Services Consultant, MasterControl Inc.

    Each year, there seems to be a buzzword that pervades the business community. This year, I recall hearing the word “collaboration” more than ever. For most organizations, the word is synonymous with “participate.”

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  • What’s in Your Training Toolkit?

    29 January, 2014 David Hofstetter, Manager, Learning and Development at New England Organ Bank

    Do we do a good enough job at identifying the real issue or are we in such a hurry to meet a requested deadline that we simply take the word of the requestor? How do we know we are truly solving the issue and not just meeting a request? 

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  • FDA Inspections: Be Prepared to Ensure Quality and Compliance

    12 November, 2013 Michael R. Hamrell, Ph.D., RAC, FRAPs, CCRA, RQAP-GCP, MORIAH Consultants

    You have just been informed by your boss that the FDA is coming to conduct an inspection of a clinical study recently completed at your facility. Does this raise your anxiety level and that of your staff to near panic levels? A FDA inspection can bring on images in your mind of a large room, bright lights and grueling questions. Probably no other agency of our government can evoke a more frightening scenario, except for maybe an IRS audit. However, with proper planning and preparation, a FDA inspection does not have to be a nightmare experience.

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  • Developing a Winning FDA Strategy for Clinical Drug Development

    8 October, 2013 Robert L. Kunka, Ph.D., The Kunka Group, Inc.

    The idea of interacting with the FDA is sometimes mysterious and unsettling for a pharmaceutical company. The average person finds it difficult to work with a large organization that they don’t understand. For example, large banks understand this and advertise themselves as the friendly bank that works to help “their neighbors” with buying a house. The FDA’s clients are pharmaceutical companies. Unlike banks, the FDA has significant leverage over the company because it is responsible for reviewing a company’s drug with the hope that FDA will approve it. While many companies are also large, there is no real leverage that the company has over the FDA. Thus, the company is at a distinct unsettling disadvantage. However, both parties have the common desire to market safe and effective drug products. Where the rubber hits the road is that the two parties need to agree on what is needed to demonstrate that the drug is safe and effective.

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  • SOP Training is Now “On-Line” But Are We Any More Compliant?

    17 September, 2013 Vivian Bringslimark, President, HPIS Consulting, Inc.

    Well, I’m told we are now more compliant with ensuring that only the most current SOP version is used for training. And yes, our Learning Management System provides us with curricula updates and “percent complete” and “percent overdue” notifications. LMSes and eDoc systems have given us efficient mechanisms to document that employees have completed their training curricula. But do they understand their procedures enough to perform them correctly back on the job? Just look at our human error deviations and training-related CAPAs. Are the numbers declining? According to an excerpt from the PDA’s Pharmaceutical Sci-Tech Discussion Group, there is “almost a 100% correlation between the percentage of read and understood SOPs and the number of compliance issues the company has.” (1) Has efficiency become the new metric for training and compliance? Using technology to read SOPs doesn’t guarantee learning transfer.

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  • Review of FDA Guidance "Codevelopment of Two or More New Investigational Drugs for Use in Combination"

    14 August, 2013 Seth A. Mailhot, Special Counsel, Sheppard Mullin Richter & Hampton LLP

    On June 14, 2013, FDA issued the Guidance “Codevelopment of Two or More New Investigational Drugs for Use in Combination.” The guidance discusses FDA’s recommendations for developing an entirely new combination therapy where none of the drugs to be used in combination have been previously developed. FDA notes in the guidance that the recommendations do not apply to combination therapies involving previously developed drugs, or the combination of a new drug with a previously developed drug. While codevelopment has generally been centered in oncology and infectious disease, FDA’s guidance is intended to address codevelopment from a high-level, making it applicable to other diseases.

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

    14 July, 2011 David R. Dills, Quality & Compliance Advisor

    This paper addresses the fundamentals of writing and enforcing your SOPs not only for compliance and in accordance with internal company policies and requirements but certainly for ensuring compliance with FDA requirements as well.

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