ICPDRE 2012 will be held during February 18-19, 2012 in Coimbatore, India. ICPDRE 2012, is to bring together innovative academics and industrial experts in the field of Product Development and Renewable Energy Resources to a common forum. The primary goal of the conference is to promote research and developmental activities in Product Development and Renewable Energy Resources. Another goal is to promote scientific information interchange between researchers, developers, engineers, students, and practitioners working in India and abroad. The conference will be held every year to make it an ideal platform for people to share views and experiences in Product Development…

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…

This 90-minute cleanroom contamination control training will review the common mistakes that people make in cleanrooms that lead to contamination, show how to develop a successful contamination control program and discuss ways to improve your facility's design and maintenance. Why Should You Attend: This 90-minute presentation will review the basics of personnel practices and discuss cleaning and disinfection. The most common source of contamination in the cleanroom are people and as such it is important to cover common mistakes in behavior and gowning. The speaker will address facility design and conditions as well since these are also a contributor to…

This training on hiring and managing CROs or AROs will show how you can ensure that you choose the right CRO/ARO based on the phase of the trial, the therapeutic area and the countries that the trials will be conducted. Why Should You Attend: A critical component in successful Clinical Research Trials is ensuring that you choose the right CRO/AOR based on the phase of the trial, the therapeutic area and the countries that the trials will be conducted. It is then important that the scope of the work be clearly defined to ensure that budget and timelines are respected…

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…

This contamination control webinar will discuss how personnel practices, transferring items into cleanrooms, facility design, construction, and sporicidal chemistries are critical and how it can be addressed in developing a successful contamination control program. Areas Covered in the Seminar: * Developing effective ways to address spore excursions. * Troubleshooting real world experiences. * Developing preventative action plans. * Learn ways to improve facility design and maintenance. * The most effective sporicidal chemistries will be discussed in detail. * Cleaning and Disinfection Methods will be addressed. * Warning Letters and 483’s from FDA will be discussed and addressed. Who Will Benefit:…

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…

This 90-minute webinar will provide guidelines for bioassay validation and regulatory documentation, the steps for technology transfer and commercial validation show how to implement the new USP chapters 1032, 1033 and 1034. Why Should You Attend: Potency bioassays are an integral part of release testing and stability studies for biotechnological products. There is a lack of clarity of how much work is required at each development phase to maintain scientific rigor and meet regulatory expectations. This webinar provides a logical plan to progress the potency bioassay from a tool to assist in pre-clinical process evaluation throughout final commercial implementation. The…

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…