• 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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  • Elements of Effective Quality Agreements

    14 August, 2013 Steven Sharf, President and Principal Consultant, GMP Concepts

    Many GxP professionals are already familiar with the expectation of FDA and the requirement in the EU to have quality agreements with third parties and suppliers. Throughout this article, I will define what a quality agreement is, when one is needed, the 24 basics that factor into this critical document, and some things to avoid when drafting one. Finally, I will discuss alternate means of communicating quality expectations when a supplier will not agree to enter into a full quality agreement.

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  • Building a Quality Plan for Implementing EN ISO 14971:2012

    14 August, 2013 Robert Packard, Regulatory Consultant, MedicalDeviceAcademy.com

    On May 16 of 2012, the European Committee for Standardization (CEN) approved a revised European National Standard for medical device risk management: EN ISO 14971:2012. There were no changes to the main body of the Standard (i.e. – Clauses 1 through 9). Instead, the revised European National (EN) version identifies seven deviations in Annex ZA, ZB, and ZC with respect to the intent of the MDD, the AIMD, and IVDD respectively. Those seven deviations are:

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  • What Does a New FDA Quality Office Mean?

    14 August, 2013 Cindy Fazzi, Marketing Communications Specialist, MasterControl Inc.

    The news that the FDA is creating a new Office of Pharmaceutical Quality probably set off the alarm bell for the industry. Does a new quality office mean new requirements? It’s the first question that comes to mind.

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  • Avoiding Human Error in Design

    14 August, 2013 BW (Ben) Marguglio, President, BW Marguglio, LLC

    Any enterprise that is engaged in activities with the potential for public and employee harm should be encouraged, if not required to develop and implement an integrated risk management, safety management, quality management and environmental management system for the prevention of events with intolerable effects. Such a management system would establish various techniques by which to analyze the safety and quality of the designs of hardware and processes.

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  • New Draft Guidance on Quality Agreements: No Passing the Buck on CGMPs

    10 August, 2013 Cathy L. Burgess, Donald E. Segal and Guillermo Cuevas,Alston & Bird LLP

    Last month, FDA released a draft guidance document entitled “Contract Manufacturing Arrangements for Drugs: Quality Agreements.” The guidance addresses relationships between the entities that introduce a drug into interstate commerce (the “Owner”) and third parties that perform some or all of the manufacturing operations for the product (the “Contracted Facilities”). The guidance describes how Owners and Contracted Facilities can use Quality Agreements to define responsibilities associated with

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  • How to Prepare your Design History File (DHF) for an FDA Inspection

    10 August, 2013 Robert Packard, Regulatory Consultant, MedicalDeviceAcademy.com

    FDA inspections strike fear into most companies, but most of the fear is due to a lack of knowledge about what to expect from the FDA. Therefore, the person responsible for the design control process at your company should read two important documents—in addition to this article:

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  • The US Medical Device Industry: Future Growth Sectors May be Different Than You Think

    10 August, 2013 Michelle Bonn, Owner & President, Expedient Trade LLC

    The medical industry is one of the most stable industries with respect to growth.  However, we are seeing interesting global trends that will impact the sustainability of medical device manufacturers and suppliers across the United States.

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  • Ten Points for Successfully Addressing Warning Letters

    10 July, 2013 By Maria Fagan, President, Regulatory & Quality Solutions LLC

    Each year, the FDA issues hundreds of warning letters to medical device companies for reasons ranging from manufacturing practice violations to breaches in labeling and misbranding. Companies responding well to the FDA’s demand for prompt compliance will ultimately return to the agency’s good graces and through the experience develop processes that result in better business, both culturally and financially. But getting to that point may be a slippery slope if the issues in the letter are not

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  • Uncertainty and Risk: Providing Value for Stakeholders

    10 July, 2013 Greg Hutchins, Principal Engineer, Quality + Engineering (Q+E)

    In Against the Gods: The Remarkable Story of Risk, the author says the mastery of risk is the foundation of modern life and is what divides modern from ancient times. By consciously or unconsciously calculating probabilities, auditors make intelligent decisions about business processes. First let’s look at a few definitions of risk.

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  • Using History to Predict the Future of Quality

    10 July, 2013 Tim Donaldson, President, Donaldson Group, Inc.

    Predicting the future is fool’s play---think Edsel, Nostradamus, even Chicken Little. But if you or your organization is wrestling with what direction to take your quality programs and your entire organization, perhaps a brief look at history will aid in developing your future strategies and culture of quality.

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  • EU Pharmacovigilance Legislation

    12 June, 2013 by Steve Jolley, SJ Pharma Consulting LLC

    The new legislation represents the biggest change to EU pharmacovigilance requirements since the formation of the European Medicines Agency (EMA) and will have a significant impact for regulators and industry.

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  • Address Root Cause of R&D

    12 June, 2013 Cindy Fazzi, Marketing Communications Specialist, MasterControl Inc.

    Pharmaceutical and biotechnology companies need to address the root cause of their drug development inefficiencies. Most companies focus their efforts on "enhanced clinical trial designs" that use biomarkers and adopt advanced statistical analyses, but they still need to hone their efforts at streamlining their drug development process, according to a recent report by the Tufts Center for the Study of Drug Development.

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  • Managing Your Medical Device Suppliers

    12 June, 2013 Michelle Bonn, President, Expedient Trade LLC

    Since the medical device and drug industries have transitioned into global market players, the concept of “virtual manufacturing” has grown in popularity and necessity. What exactly is a virtual manufacturer? In the eyes of the FDA, virtual manufacturing applies to any medical device or drug company that outsources any of its manufacturing functions.  This includes, design, packaging, sterilization & regulatory functions.

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  • Disaster Recovery and Validation

    12 June, 2013 Louis Rutledge, Manager of Services Development / Validation ServicesMasterControl Inc.

    Disaster! Today’s business world shudders at the word. With the current random occurrences of hurricanes, super storms, earthquakes, blizzards, fires, flooding and sustained power outages, it is a wonder how companies can recover to survive all of the natural or modern threats to their daily business operations and collection of business data. Today’s business world is dependent on the data created and stored for many aspects of daily operations: financial data; product specifications; designs;

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  • Ways to Ensure Supplier Compliance

    15 May, 2013 Cindy Fazzi, Marketing Communications Specialist, MasterControl Inc.

    Your suppliers are critical to your success. They can increase your company's efficiency-in terms of time, cost, and quality. But in some cases, suppliers can put their clients in hot water; this is especially true if those clients are regulated companies.

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  • Avoiding Remediation with a Good QMS

    15 May, 2013 Walt Murray, Director of Quality and Compliance Services, MasterControl Inc.

    Many companies will try to resolve compliance actions by the Food and Drug Administration (FDA) through the use of an electronic document management system (EDMS) approach that is typically post mortem. This is risky business at two critical levels. First, no EDMS approach will replace the operation of a comprehensive quality management system (QMS) that describes the integration of necessary GxP (compliance) driven quality processes. Secondly, the response will need to have a litany of justif

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  • Creating, Staffing and Managing an Inspection War Room

    4 May, 2013 Walt Murray, Director of Quality and Compliance Services, MasterControl Inc.

    When I served in the military there was a term used that is still pretty familiar today: "sound general quarters!" When this order was issued, everyone instinctively stopped what they were doing and manned whatever station was theirs during that time. All commands during general quarters came from the war room behind the bridge of the vessel.

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  • FDA Says Part 11 Guidance Remains Status Quo

    4 May, 2013 Cindy Fazzi, Marketing Communications Specialist, MasterControl Inc.

    Time and again, rumors surface about the possible update of the 2003 guidance on the scope and application of 21 CFR Part 11. The never-ending speculation attests to the enduring interest in Part 11, not to mention the continued scrutiny of the regulation.

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  • SPC vs SQC: The Strategic Difference

    1 May, 2013 Jason Orloff, Statistical & Engineering Consultant, Pharmstat

    The tension between after-the-fact inspection and defect prevention has been at the heart of manufacture since the introduction of statistical methods to industry in the 1940s. Today, to clearly divide responsibilities within an organization, and tie these very different activities to existing roles, consider a division by impact to the patient. Activities which monitor a process in real-time to prevent defects while a lot is being manufactured are known as Statistical Process Controls (SPC).

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