As manufacturing becomes more complex, stakeholders are looking to outsource elements of their manufacturing. This has provided a better utilization of resources and efficiencies, but there are challenges around maintaining compliance as a result. Companies are looking for ways to streamline their operations in the supply chain, while maintaining a high level of compliance. Risk management plans are evolving to help companies in this respect.
In this webinar, we will look at the overall concepts of risk management, the methodologies used, and the best practices for effective operational risk measurement. We will look at the risk management process, establishing risk management plans, and then common tools and technologies to support this initiative. Then, we will look at how companies can extend their risk-based processes to contractors, suppliers and external stakeholders to ensure that, no matter what stage in the product lifecycle, risk is mitigated and compliance is right the first time.
• Understand the context and landscape for risk management
• Examine the industry, regulatory and standards view on risk
• Evaluate the risk management process related to operations
• Outline the common tools and best practices for risk management
• Establish the methods to extend risk management processes to the supply chain and external stakeholders
• Review some of the commonly used technologies to achieve operational excellence
This webinar is ideal for:
• Brand owners looking to establish risk management plans throughout their processes
• Contract manufacturers looking to add risk to their processes
• Companies looking to build risk into their operational processes
• Professionals looking for risk-based tools and methods for operational excellence
Alexandre Alain, Life Science Product Manager, EtQ
Life science companies place heavy emphasis on asset management programs that help enable improved safety and reliability. Companies that implement a reliability-centered maintenance program (RCM) can reduce operational costs and improve safety while reducing regulatory risk and improving productivity. Failure to adopt this maintenance strategy can result in more frequent and impactful production failures, leading to decreased productivity, unfavorable publicity, increased oversight of your company by the FDA and a reduction in profits.
One of the largest barriers to entry of an RCM system is the perceived start-up costs in staffing, training, analysis and systems.
In this FREE webinar, EDI will show you :
• 5 key steps in achieving a successful asset management program centered on reliability
• Tools that can be used immediately to reduce operating costs
• Tips on how to evaluate true risk of asset failures to operations
• How to maintain this proactive maintenance program continuously moving forward
VP of Operations
With the first DSCSA serialization deadline just two years away, how should contract manufacturers and packagers begin to plan? Attend TraceLink's webinar for an overview of key preparatory components for external suppliers.
This will include a CMO-focused look at DSCSA requirements, key time lines and the core challenges that you're facing supporting your pharmaceutical customers’ serialization programs.
You'll hear strategies and insights from both Pharmas and CMO/CPO perspectives, including what you should do now to ensure your business is ready for 2017 and beyond.
Stay for Q+A at the end where we'll open it up to the attendees to ask questions directly to your presenters. See you on September 10th!
Pharma and Biopharma Outsourcing Association (PBOA)
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.
Wayland Rushing, Ph.D.
Senior Scientific Advisor
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.
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.
Glenn Petrie, Ph. D.
Senior Scientific Advisor
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
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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