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…

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…

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…

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…

Why Should You Attend: This interactive one-day course provides a thorough understanding of what makes water systems have microbial problems with proven solutions for microbial control. It also details how to validate that control by determining the operations and processes that logically must be evaluated in pharmaceutical water and steam systems during the validation exercise in a manner that will please FDA. Finally, and perhaps most importantly, attendees will learn how to institute simple sampling, monitoring and microbial control levels that will dramatically reduce microbial excursions and facilitate having successful and accurate root cause investigation outcomes. In short, if your…

Continuing in its Health Outcomes series, marcus evans invites you attend the two-day, industry focused event, specific to those within Outcomes Research, Global Health Outcomes and Health Economics. Hear from industry leaders within Bio/Pharmaceutical and Medical Device companies such as: Novartis Pharmaceuticals, Inc., Endo Pharmaceuticals, BD, Abbott, Takeda Pharmaceuticals, EMD Serono, Inc., Baxter Healthcare and many more! Attending this conference will allow attendees to walk away with key best practices for conducting successful outcomes research and applying pharmacoeconomics deeper into the brand management, product development and commercialization strategies of the Pharmaceutical industry. Attendees will also be provided with useful and…

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…

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…

Why Should You Attend: Potency bioassays are a regulatory requirement for release and stability testing of all biopharmaceutical products. Guidelines have remained vague on bioassay expectations due to the large assortment of mechanisms, end points and targets required for these assays. An additional obstacle is the perceived variability of the methods resulting in unacceptable failure rates due to unreliable accuracy, precision and parallelism expectations. The draft USP Bioassay suite consists of the following new chapters: USP 1032, 1033 and 1034). These chapters will be finalized soon and are already being accepted as a coherent data-driven approach to develop, analyze and…

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…

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.…

Gujarat is bestowed with diversified eco-systems which is purely reflected in diverse wildlife including birds. Nevertheless having exceptionally rich and amazing avifauna of the state, declining populations and dwindling habitats are nowadays major issues that need to be deliberated and eminently addressed. Looking to the requirement of systematic studies and scientific base for the conservation of birds of the state, Bird Conservation Society, Gujarat and ASPEE College of Horticulture and Forestry, NAU are jointly organizing a one day seminar on 'Birds of Gujarat: Present Status and Future Scenario' in association with Gujarat Association for Agricultural Sciences (Navsari Chapter). The seminar…

This webinar will review the typical non-conformances experienced in the (Medical Device) sterilization process and the course of action that should be taken by the manufacturer or contract sterilizer. Why Should You Attend: Most device manufacturers utilize a contract sterilizer for terminal sterilization of their products, e.g., radiation and EO. Non-conformances can occur during the sterilization process and CAPA needs to be issued by the manufacturer or contract sterilizer. For those that are not sterilization experts, a basic knowledge needs to be obtained to determine that the CAPA root cause, action to prevent recurrence, and verification/validation of the CAPA has…

This webinar covers production and QMS requirements for software (Excel spreadsheet) built into a medical device, as outlined in 21 CFR 820.70(i). Get practical advice on writing validation protocols and reports for Excel spreadsheets. Why Should You Attend: If you use software as part of your Production or Quality Management System (QMS) you must validate the software. This requirement is not the same as for software built into a medical device. Production and QMS software requirements are in 21 CFR 820.70(i). The most common occurrence of this kind of software involves an Excel spreadsheet. This webinar gives you practical advice…

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…

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…

This 90-minute 510(k) webinar will discuss the recent changes in the 510(k) program and will walk you through how to better format a 510(k) premarket notification submission to increase submission quality and to proactively facilitate the review process in a streamlined manner. Why Should You Attend: Recently, the 510(k) program has been evolving (e.g., 510(k) actions and improvements). In addition, the recent FDA draft guidance document suggests that more 510(k) submissions be required to meet the regulatory requirements. It is imperative that medical device industry quickly recognize the recent changes in the 510(k) process, and understand and adapt to the…

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…

This Medical Device Directive training will discuss the recently implemented and currently planned changes to the Medical Device Directives across the EU. It includes specific insight from direct involvement and work within the EU and the Commission's major improvement objectives to their system today. Specific targeted areas for change is discussed as well as the likely implementation timetable. Why Should You Attend: This webinar is focused on understanding the requirements of the Medical Device Directives, their linkage to the EU Clinical Trial Directive and the requirements of CE Marking and ISO Certification on commercializing products. The training will be discussing…

International Conference on Ecological, Environmental and Biological Sciences (ICEEBS'2012) is the premier forum for the presentation of new advances and research results in the fields of theoretical, experimental, and applied Chemical, Biological and Environment Sciences Applications. The conference is mainly managed, promoted and sponsored by Planetary Scientific Research Centre. The conference will bring together leading researchers, engineers and scientists in the domain of interest from around the world. Topics of interest for submission include, but are not limited to: Air pollution and its effects on ecosystems Brain Science and Education Coasts and Seas Cognitive Neuroscience of Memory and Cognition Computational…