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Law school prepares attorneys to condense complex sets of facts into concise, persuasive arguments that achieve client objectives. These writing skills are even more critical when drafting responses and applications to FDA that are predicated on arcane scientific and technical arguments. Because regulations are legally binding requirements predicated upon statutory laws and judicial opinions, it is essential that professionals in the pharmaceutic... 
This lesson will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order as HIPAA is now fully enforced and the government is not using kid gloves any more.It will also address major changes under the Omnibus Rule and any other applicable updates for 2017 and beyond.There are an enormous amount of issues and risks for covered entities and business associates these days.I will speak on specific ex... 
This course will provide attendees with a concise but comprehensive overview of all relevant regulatory, technical and quality elements necessary to assure successful market access. This includes: Design and TPP Pre-clinical testing and comparability Clinical testing Analytical studies Stability of biosimilar products 
An essential task in any compliance analytics workflow is to not only explore your data visually, but also to communicate your results professionally with graphic displays. Do you have the tools and skills to quickly and thoroughly perform these tasks? This course in data visualization will present methods to allow you to interactively discover relationships graphically. We will provide the foundations for creating better graphical information to... 
Characteristic for heavy lifting is the absence of standardization, which requires unique transport planning for each project. Involving items that are oversized and impossible to split over different scheduled services. They need to be transported from one place to another and then lifted or installed into place. Such undertaking requires:• Planning• The procedure and techniques of handling heavy lifting�...
Salesgasm brings to you the Intrigue Summit, Hong Kong, Aug 2017. An interactive and global annual marketing/advertising event that is a great platform for client side marketers, global brand advertisers, advertising technology providers, digital agencies, online publishers, portals and media professionals. It is a unique 2 day conference + exhibition which will have few of the finest speakers from Hong Kong and the APAC region with an intriguing...
Bionanotechnology is the term that refer to the juncture of nanotechnology and biology. This discipline aids to indicate the fusion of biological research with several fields of nanotechnology. Concepts that are improved through nanobiology are comprises with nanoscale, nanodevices , and nanoparticles phenomena that occurs within the discipline of nanotechnology.
Neuropharmacology 2017 offers a best platform to get certified worldwide with its well organized scientific program to the audience which includes interactive panel discussions, keynote lectures, plenary talks and poster sessions, Young Research Forms and 20+ Exhibitors on the topics for whole pharmaceutical industry and academics.Conference is Accredited with CME and CPD creditsNeuropharmacology 2017 Organizing Committee Members:• ...
Course "QC Laboratory Compliance and Meeting FDA Requirements" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Why should you attend: Learn the basics of FDA law and regulations governing QC laboratories Laboratory organization, personnel qualification and training requirements Documentation and record-keeping req...
Developing Technical Training in the Life Sciences is a 2-day seminar that addresses the unique challenges of developing and managing training in Life Sciences companies. The Life Sciences pose unique challenges to training developers.The first day of this seminar will concentrate on providing foundational knowledge concerning training and development within the Life Sciences. Four 90 minute sessions will be presented on this first day that will ... 
This course is designed to introduce to individuals the understanding and interpretation of the statistical concepts one uses when investigating quantitative ICH Guidelines such as analytical methods validation, procedures and acceptance criteria in calibration limits, and process and quality control. One also considers ICH Q8 and Q9. These techniques covers both clinical and laboratory applications. This applies to many areas such as stability t... 
Day one sets the stage with an overview of the HIPAA regulations including HIPAA Breach Notification and the process that must be used to determine whether or not a breach is reportable, and then continues with presentation of the specifics of the Privacy Rule, recent changes to the rules, and the basics of the Security Rule.Rules about Patient Rights and the limitations on uses and disclosures by covered entities will be explained, including rec... 
HR audits are designed to help your organization focus its attention on its human resource management practices, policies, procedures, processes, and outcomes by providing you with a structured and systematic series of questions about key compliance, risk management, internal auditing, and human resource management issues. As a process, HR audits are designed to help your organization identify potential and actual problem areas, help assess the e... 
Medical Device manufacturers operate in numerous regulatory systems that often have different requirements and are not always consistent. The new ISO 13485:2016 emphasizes this problem. Manufacturers must identify their roles, identify the regulatory requirements for that role, and incorporate them into the quality management system.The various jurisdictions, however, deal with post-market device issues in many different ways. The quality managem... 
Early clinical trials are conducted to establish initial safety of a drug. The studies are generally in small number of healthy subjects and use lower doses of the drug product. Therefore, only small amounts of investigational material are required. In order to not undertake substantial costs and to reduce regulatory burden during these early stages, the FDA has established guidelines to allow early stage investigational products to be manufactur... 
Course "Effective Internal and External Quality Assurance Auditing for FDA Regulated Industry" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Principles and Audit PlanningPlanning and preparationInternal audits are critical element of your quality management system.Your approach must be both systematic and documented to remain compliantInformation from an internal a... 
FDA and the Customs and Border Patrol Service (CBP) have become increasingly sophisticated and equally demanding in the submission of import information and adherence to government procedures. Firms that fail to understand and properly execute an import and export program find their shipments delayed, detained or refused. As of December 2016, FDA and CBP officially implemented the Automated Commercial Environment (ACE) entry filing system. You ei...
This two-day course is designed for all persons who work in, supervise, or are involved in the management of pharmaceutical and medical device Quality Control laboratories. The course will also be of benefit to entry-level Quality Assurance professionals and others who audit QC Labs, or whose responsibilities include ensuring lab regulatory compliance. This seminar will also provide participants with an understanding of how to effectively handle ...
Through this 2-day hands on interactive workshop, participants will explore the ‘Standards for the communication profession’. They will learn how the standard impacts the focus for communication strategy and the focus of their career. Participants will also be presented with the opportunity to build a strategic corporate communications function and strategy that generates the results that organisation wants. Organisations today expect corpora... 3600. International Research Conference on Sustainable Energy, Engineering, Materials and Environment
We would like to invite you to participate in the International Research Conference on Sustainable Energy, Engineering, Materials and Environment (SEEME), which is organised by researchers from Northumbria University in partnership with Theorem Conferences and Events. This event will be held from the 26th – 28th of July 2017 at Northumbria University, in Newcastle.This conference offers a pl...
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