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Last Updated Sunday, March 29 2015



Genotoxicity: How Low Should You Go?
March 26, 2015
Genotoxicity: How Low Should You Go?
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.

Harley Everett Wlcox 
Senior Scientific Advisor 
ABC Laboratories

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Location: Ramsey, NJ
Contact: Tim Wright
Phone: 201-825-2552
Strategically Using Bowtie Risk to Effectively Control Your Internal Compliance Program
July 22, 2014
Strategically Using Bowtie Risk to Effectively Control Your Internal Compliance Program
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

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

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

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