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Microbiology Conferences take immense pleasure to announce the Euro Microbiology 2018 to be held on June 28-29 2018 at Amsterdam, Netherlands which includes prompt Keynote Speakers Workshops Symposium Special Session Oral Presentation Poster Presentation and Exhibitions in 11th World Microbiology & Immunology CongressIt aims at bringing together the Professors, Doctors, Scientists, Re... 
FDA inspects many different kinds of firms. If the FDA regulates your product, they can show up at your lobby and say, “I am here to conduct an inspection.” What do you do? What have you done to prepare for an inspection? How do you deal with the investigator, including their personality? The scary part is having to explain the error of your ways to the FDA and above all, managing an administrative action, e.g., Warning Letter or Import Alert... 
Stem cells harness the power to differentiate into numerous cells upon stimulation. This has led to their wide exploration across all of medicine, including high risk diseases. Of course, significant scientific breakthroughs in the use of stem cells to prevent, diagnose, and treat numerous diseases has caused numerous start-up companies to form. Despite, such promise, the FDA has yet to approve stem cell therapies for a wide range of diseases, ex... 
The FDA regulates manufacturers of medical products such as devices, pharmaceuticals, tissue products, and biologics. However, the regulations don’t usually extent to suppliers. Instead, the FDA expects the medical product manufacturer to implement an effective program to qualify and re-qualify suppliers for these regulated industries.An effective supplier qualification program has some specific elements including determining expectations and r...
Allied Academics conference on Psychiatry and Psychological disorders from June 28-29 2018 in Dublin Ireland will provide a global podium for all the high minded persons associated with psychiatry and modern therapies to cure psychological disorders Psychiatry 2018 is a major conference devoted to all the psychiatrists and psychological researchers with the theme of “Disseminating information on Psychology and Psychological ...
2466. Quality by Design: A New Paradigm for the Development and Commercialization of Biopharmaceuticals
The paradigm for biopharmaceutical development and commercialization has been dramatically impacted by the advent of Quality by Design approaches that have been driven by the regulatory authorities and encapsulated in recent FDA, EMEA, and ICH guidelines. The traditional approach, in which the process provides for the characteristics of the product (a paradigm in which “the process is the product”), is being replaced by development programs t...
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The growth of digital assets has been phenomenal and the pace of growth AND the importance of managing and monetizing those assets is increasing with each passing month. Over the past 16 years at DAM Europe we’ve seen it all – from slow incremental change all the way to rapid, disruptive, revolutionary change. We’ve seen it, discussed it, explored its implications and presented opinions on what to do as a consequence.DAM Europe 2018 will be...
2469. WORTHECH18 MUNICH
WORKTECH18 Munich is the forum for all those involved in the future of work and the workplace as well as real estate, technology and innovation.WORKTECH18 Munich will attract some of the biggest and brightest names to debate, discuss, and divulge the last thinking on the Future of Work and the Workplace.Join senior professionals from real estate, facilities, HR, technology, executive management architecture, design and professional advisors to li...
This training focuses on functional safety aspects for process, oil & gas, petrochemical and chemical industries according to IEC 61508 / IEC 61511. This includes the complete safety lifecycle in the context of Safety Instrumented Systems (SIS) projects.These courses comprise 3 days of classroom tuition and practical guidance, for understanding and mastering the application, principles and requirements of Edition 2 IEC 61508 & Edition 2 o...
This three-day course will provide the participants with a comprehensive understanding and valuable knowledge of the requirements and compliance issues of international transport of dangerous goods. The course will cover the current International Maritime Dangerous Goods Code (IMDG), Edition 16, and the new and important changes in Amendment 38-16. In addition to discussion of the IMDG Code, the attendees will participate in group activities and ...
This webinar will provide an in-depth discussion of USP <1226>, 'Verification of Compendial Methods' requirements. We will discuss FDA 483s on the subject of Method Verification to understand current FDA expectations.Why Should You Attend:This webinar will provide an in-depth discussion of USP <1226>, 'Verification of Compendial Methods' requirements. Conditions under which Methods can be classified as 'basic' and not require verifica...
This risk assessment training will discuss why it is essential to perform a risk assessment and what kind of breaches can occur. It will also list what HIPAA regulations require and what it should tell you.Why Should You Attend:This webinar will discuss three reasons why a risk assessment is necessary:First, both the HIPAA Privacy and Security Regulations require a Risk Assessment for the organization to be HIPAA compliant.Second, as a result of ...
This webinar will discuss the new elemental impurities test requirements as per the new ICH Q3D and USP 232/233 Guidelines, the testing required to comply with it and how to do proper risk assessment and analytical measurements, which drug products are within the scope, the documentation related to control of elemental impurity, which methods required to be validated.Why Should You Attend:Manufacturers of new drug products are required to comply ...
This training program will provide attendees with a better understanding of the importance of a change control procedure, what areas inspectors tend to look for during an audit and the challenges that change control programs present to companies in their efforts to manage it. Common deficiencies will also be discussed and attendees will be provided a template to evaluate their own programs.Why Should You Attend:An effective quality system program...
This Webinar is geared toward those who require a working knowledge of biocompatibility.Why Should You Attend:All medical devices that have direct or indirect contact with the human body require an assessment of the biocompatibility of the materials used to manufacture the device, with the test schedule depending on the nature and duration of body contact. Domestic and international regulatory bodies are encouraging the use of risk-based approach...
In this Water System Webinar the author will explain the process he uses as a consultant for investigating and solving water system or product contamination problems with water organisms. Case studies of real life problems he has resolved will be presented to illustrate the process.Why Should You Attend:Have you ever encountered what appeared to be a water system problem or worse, a product contaminated with a water-type organism? If so, you alre...
This training program will discuss the history and origin of a model validation. It will also discuss the requirements by the OCC for a model validation, and what exactly a model validation should include. The session will also analyze the elements of a model validation to know what to look for in an RFP, and detail the requirements included in Final Rule 504.Why Should You Attend:According to the Office of the Comptroller of the Currency (OCC), ...
Carriers are looking to meet customer demands and deliver continuous business growth without dramatically increasing costs. Insurance AI & Analytics USA (June 27-28, Chicago) will explore how carriers can take advantage of AI, machine learning, chatbots and more to deliver both operational efficiency and a seamless, omnichannel customer experience.Join this industry leading summit for insights on:Build the foundation to deliver AI and Machine...
Artificial Intelligence is deemed to be the main driver of the 4th Industrial Revolution. Until recently, practitioners have faithfully relied upon neo-classical models to make decisions and to measure performance, whether it’s in financial organisations or marketing corporations. AI is the new technology that offers an automated solution to these processes. It has the capability to replicate cognitive decisions made by humans and remove behavi...
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