Webinars

    Analytical Method Transfers: Practice and Pitfalls

    Analytical Method Transfers: Practice and Pitfalls

    July 23, 2015

    When planning your development timeline, the transfer of analytical methods is rarely more than a blip on your radar. But when a method doesn’t perform as expected, it can take precious days of investigative work to find the problem, and even more to correct it. Learn about common pitfalls that cause method transfer failures, how to decide what type of method transfer makes sense for your study, and how to implement a fail-safe communication plan that will help put your outsourcing relationship on the right course.

    Speaker:
    Wayland Rushing, Ph.D.
    Senior Scientific Advisor
    ABC Laboratories

    Dr. Wayland Rushing is a technical expert in Chemistry Manufacturing and Controls (CMC) program design, analytical development and regulatory submissions. Over his career, he has led CMC development programs for a wide array of biopharmaceuticals, including parenterals, inhalation drugs, and other pharmaceuticals with complex delivery systems. Dr. Rushing is a subject matter expert in HPLC and GC method development and validation, extractables and leachables program design and regulatory submission requirements; has drafted multiple IND and NDA submissions; and assists ABC clients in responding to FDA deficiency letters. He currently serves on Parenteral Drug Association (PDA) advisory committees for Technology Transfer and Elastomeric Closures and Seals Defects and was a co-author of the PDA Technical Report No. 65 – Technology Transfer.
    Register Now!


    Location: Ramsey, NJ
    Contact: Tim Wright
    Phone: 201-825-2552


    Obsolete methods have you feeling on the hook?

    Obsolete methods have you feeling on the hook?

    May 28, 2015

    Evolving CMC Analytical Techniques for Biopharmaceuticals

    Regulatory expectations for understanding product impurities and degradants in biopharmaceuticals continue to increase, and many biopharmaceutical developers are finding their “current” CMC methods are quickly becoming obsolete. New, highly sensitive and specific technologies are now emerging from R&D into the QC lab and are becoming the “new normal.” But how do you address heightened regulatory expectations while managing the risk associated with mid-course changes to methods?

    Join us for 60 minutes of discussion on how to bring your program to current technologies with confidence.


    Speaker:
    Glenn Petrie, Ph. D.
    Senior Scientific Advisor
    ABC Laboratories

    Register Now!


    Location: Ramsey, NJ
    Contact: Tim Wright
    Phone: 201-825-2552


    Genotoxicity: How Low Should You Go?

    Genotoxicity: How Low Should You Go?

    March 26, 2015

    Analytical Evaluation of Mutagenic Impurities

    Impurity evaluations can take on a whole new level of specificity when mutagenic risk is present. Whether an evaluation is in support of clinical development, a marketing application, or post-commercial manufacturing changes, acceptance criteria often require parts-per-billion detection. On the other hand, “As Low as Reasonable Practicable” rules may not always apply. Misguided analytical strategies waste time and money. Many have left promising development programs in limbo.

    This webinar will address recent ICH M7 and other relevant guidelines that address genotoxic and carcinogenic potential. It also will discuss various genotoxic sources, including synthetic processes and impurities/degradation products, as well as relevant analytical testing methodologies.


    Speaker:
    Harley Everett Wlcox 
    Senior Scientific Advisor 
    ABC Laboratories

    Register Now!


    Location: Ramsey, NJ
    Contact: Tim Wright
    Phone: 201-825-2552


    Strategically Using Bowtie Risk to Effectively Control Your Internal Compliance Program

    Strategically Using Bowtie Risk to Effectively Control Your Internal Compliance Program

    July 22, 2014

    Global, compliance driven industries such as Life Sciences, Animal Health and Healthcare now face ever increasingly complex legislative landscapes required by new regulations and international standards. Failure to comply can quickly result in severe business disruption, legal and regulatory action, supply chain breakdown—and eventually market share and brand erosion.

    Understanding the enterprise risk control framework across this challenging new operational landscape requires risk methodologies different from those used in the past in order to drive a more focused, data based, day-to-day decision making strategy. Celgene, a global biopharmaceutical leader, has been exploring the use of Bowtie Risk methodology to streamline this desired framework. In conjunction with EtQ Reliance, an enterprise compliance platform, and The Aloft Group, Celgene will present their vision to streamline data collection and reporting to more fully understand and control their compliance data and variables allowing executive management to quickly and more effectively make risk-based decisions.

    Please join us for this joint webinar as we introduce how Bowtie Risk can proactively be used to mitigate risk by analyzing threats that can lead to undesired compliance events. We will discuss how to combat such threats and assess where controls need to be improved or new ones added.

    See how these tools can be used to effectively describe complex risk scenarios to senior executives and boards and gain support on the strategic management of risk, as well as:

    • Why Bowtie Risk is an effective method of Risk Management and how it works
    • How to apply Bowtie Risk within your organization's unique set of compliance variables
    • When to use Bowtie Risk to set up controls, assess threats and identify mitigation strategies to minimize risk on hazards that are elusive, but critical to the business

    Speakers:
    Kenneth Ray, Senior Director, Corporate Compliance Governance Celgene
    Robert Dodd, Senior Director, Safety & Risk Management Aloft Aviation Consulting
    Tim Fischer, Global Compliance Account Manager EtQ

    Register Now!


    Location: Ramsey
    Contact: Agnes Shanley
    Phone: 201-825-2552