http://www.worldconferencecalendar.com/index.php?option=com_conference Sun, 05 Feb 2012 04:12:55 +0100 FeedCreator 1.7.2 http://www.worldconferencecalendar.com/component/option,com_conference/page,show_ad/catid,5/adid,2831/Itemid,0/ It is our pleasure to announce that the 3rd International Conference on Environmental Aspects of Bangladesh (ICEAB12), is going to be held on 13~14 Oct. 2012, in the University of Kitakyushu, Japan, by Bangladesh Environment Network Japan (BENJapan). The ICEAB12 provides vibrant opportunities for researchers, industry practitioners, students & fellow citizens to share their researches, ideas, & review various environmental aspects of Bangladesh, Japan and other regions of the globe. We are hopeful that researchers around the world who are working on various environmental & related issues will gather and share their works, views and move forward to work together for betterment of the world. We are soliciting unpublished and original works. Dual-submissions, self-plagiarism & plagiarism are strictly prohibited. All papers will be peer-reviewed by at least two reviewers. Researchers – around the World, are welcome to submit their unpublished original works & attend! - Physical and Life Sciences Fri, 03 Feb 2012 00:00:00 +0100 http://www.worldconferencecalendar.com/component/option,com_conference/page,show_ad/catid,5/adid,2785/Itemid,0/ IBC’s 3rd Annual Biosimilars Asia 2012 is the largest and most anticipated meeting of its kind in Asia. Attended by biosimilars, innovators, generics and biopharma alike, the unique mix of attendees from all over the world will share their experiences and opinions about the future of biosimilars. Tough questions will be answered and positions will be challenged but all will walk away bristling with ideas, opportunities and be more informed. Biosimilars Asia 2012 continues to deliver a quality of speakers and discussions unmatched in Asia. REASONS WHY BIOSIMILARS ASIA IS A ‘MUST ATTEND’ •Biosimilars Asia 2012 is Asia’s LARGEST CONFERENCE addressing complex strategy questions, attended by regional and global innovators, generics, biopharma and biosimilars companies •STRATEGIC PLENARY KEYNOTE SESSIONS with delegates from Biosimilars Asia 2012, China Pharmaceutical R&D Summit & Vaccines China 2012 •DON’T MISS OUT on ‘no-holds-barred’ discussions featuring innovators, generics, biosimilars and industry thoughtleaders! - Physical and Life Sciences Wed, 25 Jan 2012 00:00:00 +0100 http://www.worldconferencecalendar.com/component/option,com_conference/page,show_ad/catid,5/adid,2726/Itemid,0/ Topics of interest include, but are not limited to: Mineralogy Petrology Geochemistry Geomorphology Paleontology Stratigraphy Structural geology Engineering geology Sedimentology Earth Science and Technology Economic Geology Environmental Geology Development and Production of Mineral Resources Rock Mechanics Folds, fractures and fabrics Strike-slip zones and extensional regimes Strain analysis Experimental rock deformation Mineral Processingm Waste Management & Recycling Applied Geology Geological Mapping - Physical and Life Sciences Mon, 16 Jan 2012 00:00:00 +0100 http://www.worldconferencecalendar.com/component/option,com_conference/page,show_ad/catid,5/adid,2723/Itemid,0/ The 8th International Conference of Clinical Laboratory Automation (Cherry Blossom Symposium) will be held from April 11 to 13 in Seoul, Korea. As one of the most highly acclaimed meetings in the field of laboratory automation, it takes place biannually in different countries in Asian region - Physical and Life Sciences Mon, 16 Jan 2012 00:00:00 +0100 http://www.worldconferencecalendar.com/component/option,com_conference/page,show_ad/catid,5/adid,2687/Itemid,0/ This 90-minute Internal Audit webinar will cover the three foundational elements that support an effective Internal Audit program - establishing Internal Audit Program objectives, developing audit plans, and writing effective non-compliances. Why Should You Attend: Internal auditing drives continual improvement and reminds everyone that Quality comes first! Auditing is an assessment tool that provides a reliable performance indicator of your organization’s system and processes. In other words, an internal audit is an audit of an entity's internal control systems and procedures and how the system and procedures are implemented. Companies that establish internal audits as part of their culture to practice discipline of process control will benefit in the long run with stable and reliable processes. In 90 minutes we will cover three foundational elements for designing an effective internal audit process. These areas include how to establish Internal Audit Program objectives, develop audit plans, and write effective non-compliances. - Physical and Life Sciences Tue, 10 Jan 2012 00:00:00 +0100 http://www.worldconferencecalendar.com/component/option,com_conference/page,show_ad/catid,5/adid,2686/Itemid,0/ This webinar on Online Auditing Techniques will discuss applicable environments for online auditing, the different types of interactive programs used over the Internet, and how to conduct online audits. Why Should You Attend: One third of US based companies have transitioned their manufacturing floors to seventy-two million virtual seats sitting in a worldwide supply chain, changing roles from local hands- on to world-wide consulting in Europe, Asia, or India to resolve product or process issues. For many of these global teams, managing the world-wide supply chain is the foremost objective and scope of the dispersed companies’ ISO 9001 certification. Virtual auditing presents a host of benefits to companies including: help to solve communication issues because online auditing will streamline and maintain websites, documentation, and record control in the online environment through reoccurring scheduled reviews. - Physical and Life Sciences Mon, 09 Jan 2012 00:00:00 +0100 http://www.worldconferencecalendar.com/component/option,com_conference/page,show_ad/catid,5/adid,2685/Itemid,0/ This 3-hr virtual seminar - OSHA Asbestos and Mold Awareness - will cover OSHA's regulations on Asbestos and specific guidelines and general regulations on Mold. Why Should You Attend: Asbestos is one of the most highly regulated substances, and for good reasons as it’s a potent carcinogen with no known safe exposure. Of all of the toxic and hazardous substances it could have regulated, OSHA chose to regulate Asbestos first. Mold, on the other hand, is an even more ubiquitous contaminant in buildings, yet OSHA has not even attempted any regulations specific to it. Instead, they have a set of guidelines as well as several general regulations that all apply. In this 3-hour session we will cover the required elements of the 2-hour awareness training OSHA requires for Asbestos, as well as the OSHA Mold guidelines and many of their applicable regulations. - Physical and Life Sciences Mon, 09 Jan 2012 00:00:00 +0100 http://www.worldconferencecalendar.com/component/option,com_conference/page,show_ad/catid,5/adid,2684/Itemid,0/ This OSHA Inspection and Accident Investigation training will provide practical tips for safety professionals and managers on what the OSHA inspectors will look for, how to respond to a letter of complaint, how employees and unions figure into the inspection equation, and what you must do to expedite the inspection and help resolve issues before they become major problems. Why Should You Attend: Perhaps of all of the interactions that occur with regulatory agencies, the unannounced OSHA inspection is the most stressful, and least understood by business owners. The key to managing a surprise OSHA Inspection or a letter of complaint directed at your company is to understand what the process is and what the OSHA inspectors are looking for. This presentation will explain what the process is for an OSHA inspection, and how to respond to a letter of complaint. Also, this presentation will explain what inspectors are looking for, how employees and unions figure into the inspection equation , and what you must do to expedite the inspection and help resolve issues before they become major problems. - Physical and Life Sciences Mon, 09 Jan 2012 00:00:00 +0100 http://www.worldconferencecalendar.com/component/option,com_conference/page,show_ad/catid,5/adid,2683/Itemid,0/ This OSHA compliance training will help you understand the importance of getting started as a safety professional and where to start. You will also learn the importance of getting management buy-in. The beginnings of your career in Safety can be intimidating - wondering where to start, You have been asked if the employees have been trained to operate a piece of equipment and you answer with that confused look, your insurance company wants the latest OSHA 300 log and you have no idea, the company president wants the safety committee meeting minutes, you don’t have one in place – this class will show you where to start. This 3-hr virtual seminar will equip you with the knowledge and guidance that will allow you to feel secure in your decision making process, as well as know how to prioritize a day. We will also ensure you know how to handle a worker’s compensation case from start to finish. - Physical and Life Sciences Mon, 09 Jan 2012 00:00:00 +0100 http://www.worldconferencecalendar.com/component/option,com_conference/page,show_ad/catid,5/adid,2682/Itemid,0/ This webinar will help you understand OSHA’s requirement for a pre-demolition engineering survey, including what documents to have in place, for renovation and complete demolition of buildings/structures. Why Should You Attend: Due to the significant number of fatalities, injuries, fires, spills/releases, and “near misses” in construction/demolition activities OSHA requires an engineering survey to be made by a “competent person”. That person may be a professional engineer (PE), certified safety professional with demolition experience, or a demolition contractor employee with adequate experience and communication/writing skills. The survey may be brief for small structures or extensive for large facilities. Due to unauthorized persons trespassing or accidentally accessing the area and multiple employers working on these projects they are a significant target for lawsuits. Plaintiff attorneys target the failure of conducting, producing, and making available a pre-engineering survey. This webinar will help you understand OSHA’s requirement for a pre-demolition engineering survey for renovation and complete demolition of buildings/structures. - Physical and Life Sciences Mon, 09 Jan 2012 00:00:00 +0100 http://www.worldconferencecalendar.com/component/option,com_conference/page,show_ad/catid,5/adid,2681/Itemid,0/ This 3-hr virtual seminar on OSHA Subpart Z (or IH) Regulations will discuss many of the individual standards as well as the general model and approach and “template” that OSHA takes with these IH regulations. Why Should You Attend: Ever wonder what all of those long industrial hygiene (or IH) regulations are about in OSHA’s Subpart Z (in either 1910 – General Industry or 1926 – Construction)? You are not alone! Many OHS professionals have questions about these “Expanded Health” standards! These IH standards can be quite involved and, at times, confusing. This can obviously lead to non-compliance and then on to – hazards, exposures, illness, citations, and fines – and no one wants that! In this workshop we will look at and discuss many of the individual standards as well as the general model and approach that OSHA takes with their IH regulations – there is a “template” of sorts that OSHA tends to follow. A fundamental working knowledge and expertise of this template and approach can help even the non-IH be better able to manage these IH regulations. - Physical and Life Sciences Mon, 09 Jan 2012 00:00:00 +0100 http://www.worldconferencecalendar.com/component/option,com_conference/page,show_ad/catid,5/adid,2657/Itemid,0/ Why Should You Attend: This course provides attendees with an understanding of the role that Quality Agreements and DMFs play in the FDA's regulatory approval process for drugs and biologics. The course will take participants through a step-by-step process of when Quality Agreements are appropriate, how they should be prepared, formatting, content and negotiations around the agreement. The DMF section will explain preparation and explain the types of information essential for any Drug Master File. Additionally, this course explains why "one size does not fit all" and emphasizes the importance of customizing DMFs in both preparation and maintenance for particular products and businesses. - Physical and Life Sciences Thu, 05 Jan 2012 00:00:00 +0100 http://www.worldconferencecalendar.com/component/option,com_conference/page,show_ad/catid,5/adid,2656/Itemid,0/ The US FDA has issued a draft guidance document outlining a suggested approach to complying with current good manufacturing practice (CGMP) requirements for drugs intended soley in Phase 1 studies.With this guidance and an accompanying regulation, US FDA formally recognizes specific standards for the manufacture of small amounts of drug products for phase 1 studies and formulating an approach to cGMP compliance that is appropriate for the particular stage of drug development. This presentation will give an insiders insight into the the new guidance and regulation and discuss the rationale for such. Areas Covered in the seminar: - Background and rationale for guidance and proposed regulation - Scope - CGMP Statutory and Regulatory Requirements - Recommendations for complying with the statue- personnel,Quality Control Function, facility and Equipment, - Control of Components, Production and Documentation, - Laboratory Controls,Container Closure and Labeling, -Distribution and Record keeping - Special production situations - Biological and Biotechnological Products - Physical and Life Sciences Thu, 05 Jan 2012 00:00:00 +0100 http://www.worldconferencecalendar.com/component/option,com_conference/page,show_ad/catid,5/adid,2655/Itemid,0/ This 6-hr virtual seminar on Analytical Procedures and Procedures Transfer will address procedure selection and assessment for pharmaceutical substances and products, ICH and USP guidelines for procedure validation and verification and how you can identify issues upfront to improve success of the project. Why Should You Attend: Analytical procedures are typically developed early in the clinical trial phases of drug development. During the movement of the product toward commercial product status, formulations change, concentrations change, and presentations change. It is crucial to assess and to re-assess the procedures that are being used throughout the lifecycle of the product. This 6-hr training will address procedure selection and assessment. You will learn how to put in place a robust transfer program in order to head off issues. Unearthing issues at this stage, rather than during routine manufacture, will improve the overall success of the project. - Physical and Life Sciences Thu, 05 Jan 2012 00:00:00 +0100 http://www.worldconferencecalendar.com/component/option,com_conference/page,show_ad/catid,5/adid,2654/Itemid,0/ Why Should You Attend: Both foods and drugs have been regulated by the Food and Drug Administration (FDA). There has been a class of entities, since 1997 known as new dietary ingredients that had formerly been largely unidentified. This class of extracts and compounds and the like is coming under new scrutiny and regulation. A burden is being placed on those in the food production and distribution network. Don’t learn about these by receiving a warning letter or other formal action from the FDA. Be proactive and identify and reduce or eliminate your production, documentation and legal risks. The FDA has recently issued draft guidelines interpreting the 1997 rules directed to new dietary ingredients. The risk of seizure and fines based on charges of adulteration and mislabeling are real. This seminar will help you understand the new FDA regulations directed to the place of New Dietary Ingredients in the FDA regulatory Scheme. Areas Covered in the Seminar: A series of guidelines interpreting the original rules, including: - Brief History of regulation of dietary supplements. How to identify a new dietary ingredient? - When you must notify FDA about a new dietary ingredient? - What information the FDA notification must contain? - What kind of safety studies will FDA accept? - How and when should I conduct and report toxicity research? - Physical and Life Sciences Thu, 05 Jan 2012 00:00:00 +0100 http://www.worldconferencecalendar.com/component/option,com_conference/page,show_ad/catid,5/adid,2653/Itemid,0/ Why Should You Attend: This webinar will address excursion and the best practices for troubleshooting them. The most common sources for excursion are personnel practices, cleaning and disinfection program, facility design and conditions, and bringing items into the cleanroom. This webinar will discuss the details of specific excursion investigation for outbreaks of molds, vegetative bacteria, and Bacillus. End users will gain a new understanding of the complexity of troubleshooting outbreaks and contamination issues based on real life experiences. Areas Covered in the seminar: - Review data from “real-world” examples. - Learn how to develop solutions to your microbial control problems. - This seminar focuses on both preventative measures and corrective actions. - This session will be interactive with audience input. - Physical and Life Sciences Thu, 05 Jan 2012 00:00:00 +0100 http://www.worldconferencecalendar.com/component/option,com_conference/page,show_ad/catid,5/adid,2652/Itemid,0/ This 3-hr virtual seminar on the FDA New Drug Approval Process will cover the NDA and ANDA review and approval process including a discussion of preparing NDAs and ANDAs, relevant meetings, timing, costs, approval requirements and other FDA regulatory requirements. The various existing regulatory approval pathways (the “full” NDA, the 505(b)(2) NDA and the ANDA) will be discussed. Why Should You Attend: This virtual seminar is intended for Regulatory Affairs Professionals, Managers, Consultants, Scientists and Research Analysts seeking an introduction to the FDA new drug approval process. This presentation will focus on the new drug application (“NDA”) and the abbreviated new drug application (“ANDA” or “Generic Drug”). The presenter will provide attendees with an overview of the NDA and ANDA review and approval process including a discussion of preparing NDAs and ANDAs, relevant meetings, timing, costs, approval requirements and other FDA regulatory requirements. Within the context of the approval process, the various existing regulatory approval pathways (the “full” NDA, the 505(b)(2) NDA and the ANDA) will be discussed. - Physical and Life Sciences Thu, 05 Jan 2012 00:00:00 +0100 http://www.worldconferencecalendar.com/component/option,com_conference/page,show_ad/catid,5/adid,2651/Itemid,0/ This webinar will cover the basics of design controls for medical devices, and provide recommendations for implementation of a compliant design control system. Also discussed will be design control requirements for devices already in distribution. Documentation requirements for each design stage will be included as well. Why You Should Attend: Prior to introduction of a new device, or even a modified design for an existing device, a systematic process must be followed. This process must ensure that all requirements are met. A firm's design control process must meet all regulatory requirements, but at the same time not be as unwieldy as the present a barrier to timely market introduction. This webinar will cover the basics of design controls, and provide recommendations for implementation of a compliant design control system. Also discussed will be design control requirements for devices already in distribution. Documentation requirements for each design stage will be included as well. - Physical and Life Sciences Thu, 05 Jan 2012 00:00:00 +0100 http://www.worldconferencecalendar.com/component/option,com_conference/page,show_ad/catid,5/adid,2650/Itemid,0/ This Process Validation training will look at the underlying statistical concepts to perform an effective process validation. The webinar examine elements of the FDA regulations for process validation (21 CFR §820.75) as well as the corresponding requirements in ISO 13485. The FDA’s Quality system regulation requires device manufacturers to validate processes when they don’t fully verify the resulting output. Based on Warning Letters, the FDA expects manufacturers to validate processes when the output check uses sampling instead of 100% inspection. The presentation looks at these aspects of process validation using the unifying approach of a statistical model. Rather than a fundamental examination of how to perform process validation, this seminar covers the tools necessary to use the statistical model. Why Should You Attend: If you conduct process validation, you need to ensure that your results are valid. Beyond the regulatory requirements, statistical approaches will help you achieve the desired result – processes that produce only conforming material. This is the essence of the statistical approach. This webinar presents the statistical approach that will help you validate your processes. Your team should attend this webinar if you cannot easily answer these questions. - Physical and Life Sciences Thu, 05 Jan 2012 00:00:00 +0100 http://www.worldconferencecalendar.com/component/option,com_conference/page,show_ad/catid,5/adid,2649/Itemid,0/ This 3-hr training will discuss medical device regulations and law in the US, Europe and Canada. It is designed to help the audience with their global compliance and regulatory intelligence, which is necessary to streamline the regulatory process in an organization to achieve sustainability and to remain sustainable and competitive in global markets. This seminar is a “How To Guide” intended to streamline the decision-making process in a systematic manner. Why You Should Attend: The global regulation of medical devices is rapidly evolving, integrating the regulatory systems of the most advanced medical device regulations. To be able to achieve sustainability and to remain competitive in global medical device markets, it is necessary to streamline the regulatory process what would help to reduce or eliminate differences between countries, gain regulatory compliance at a reduced cost, allow intended users and other stakeholders earlier access to advanced and innovative medical device products for treatments and improve healthcare in a safe and effective way during post-marketing through surveillance program. - Physical and Life Sciences Thu, 05 Jan 2012 00:00:00 +0100