All Conferences

Course "21 CFR Part 11 compliance for software validation and SaaS/Cloud" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: • This interactive two-day course explores proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments. • Many companies are outsourcing IT resources and getting involved with Software as a Service (SaaS) and cloud computing. These vendors are not regulated and therefore regulated companies must ensure compliance for both infrastructure qualification and computer system validation. It is the regulated company that wants…

Course "Project Management Overview for Auditors" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: What are the basic steps for implementing a project using Project Management methodology? What role will I have to play in implementation? What happens if I've never worked on a Project of this size before? This class will explain what Project Management is and provide tools for understanding, and participating in, a Project. We'll cover how to write a clear and concise project statement, the basic phases of Project Management, and how to…

The high-velocity day kicks off with fast-paced educational sessions covering the hottest trends in brand activations. You’ll get insights on the latest marketing strategies and case studies across promotion, social, mobile, influencer, experiential and content marketing. Your ticket also provides access to the 2018 PRO Awards Luncheon Gala, recognizing best-in-class marketing campaigns. From experiential and multicultural to entertainment and local—the PRO Awards Gala is your chance to learn from the best of the best campaigns from the past year. URL: Tickets: https://go.evvnt.com/224535-1?pid=154 Prices: Marketing To Women In The #MeToo Era + PRO Awards Gala (Until May 18): USD 675.0 Marketing…

The Global Online Marketplaces Summit brings together C-Level management from top portals around the world. This year's theme is '"From Classifieds to Market Places - The Evolution of an Industry"' exploring a diverse range of trends such as artificial intelligence, virtual reality, disruptive business models, all creating new threats and opportunities for the industry. The conference will be curated by Simon Baker, the former CEO of the REA Group, Chairman of the Mitula Group & Real Estate Investar and serial digital investor, and Peter Zollman, Founder of the AIM Group.. Time: 8:00 am - 2:00 pm. Category: Classes / Courses…

Clinical trials are a critical element of drug development. Introducing the investigational products to consenting subjects under Good Clinical Practices (GCPs), the Essential Documents are evidence of the compliant conduct of a clinical trial. Learning Objectives: >. Recognize the purpose and value of documents, files and data as assets in a drug development program >.Identify industry best practices and their use and adoption >.Distinguish paper and digital formats and understand transitioning from paper >.Demonstrate an understanding of the complete life cycle of regulatory content >.Discuss Best Practices for Essential Documents in their handling and storage. >.Discuss the benefit and challenges…

Who Should Attend: >. Records Management Specialists at Sponsors, CROs, FSPs, Vendors, Clinical Sites >. Personnel involved in set up, maintenance, and auditing of the Trial Master File >. Project and/or Study Managers >. Project and/or Clinical Trial Assistants >. Clinical Operations Administrators >. Clinical Research Monitors >. Quality Assurance Personnel >. Compliance Auditors >. Consultants working in the life science industry involved in managing regulated content >. eCTD Publishers and Content Providers at Sponsors, CROs, Service Providers, Software Providers >. Regulatory Operations Personnel >. Regulatory Affairs Professionals >. Anyone new to the eCTD Delivery Paradigm >. Professionals preparing eCTD…

Cash management seems simple enough; money comes in, money goes out. However, managing the flows and gathering the right information at the right time is complicated and tricky. Understanding the pitfalls and anticipating Murphy’s Law is both a science and an art. Why You Should Attend: Cash is King! You’ve heard that I’m sure. But managing cash can be a pain in the butt. Establishing procedures, maintaining banking relationships, and getting good, reliable information are some of the key elements of good cash management. Areas Covered in the Session : >. Inflows, outflows, and information >. Bank products and services…

OVERVIEW Every year the Occupational Safety and Health Administration (OSHA) publishes the “Top 10” list of most cited regulations of the previous fiscal year. The ‘Top 10” list that will be reviewed in this webinar will consist of both General and Construction Industry. If you are responsible for managing personal safety and OSHA regulatory compliance, you will want to participate in this webinar. You will gain a better understand of what OSHA’s Compliance Safety and Health Officer’s (CSHO) are observing in the field when conducting their inspection and what citations are being issued. You will also learn how to avoid…

OVERVIEW Don takes his audience through an educational and interactive class teaching how thought process and mindset work and natural methods for handling everyday anxiety and stress that improve mindset and increase performance. WHY SHOULD YOU ATTEND Work Life Balance is a challenge by itself, but when your home life is chaotic due to someone dealing with an anxiety or personal issues it can be disastrous. Learning how to handle that can be the difference between a business succeeding or failing. AREAS COVERED • Basic understanding of how the brain operates • Anxiety and its effects on the brain •…

A tougher U.S. FDA expects a company to maintain certain documents in equipment, process and product software V&V. These documentation requirements can assist in a 21 CFR Part 11 CGMP records / signature V&V as well. This training program will provide valuable assistance to all regulated companies in evaluating their existing or anticipated software V&V activities and documentation requirements, especially in light of the changes in the FDA's stance vis a vis industry compliance, past problems, and the growing cloud environment. It will help attendees understand and recognize the most common software V&V failings and their fixes. The webinar will…

The United States Food and Drug Administration (FDA) regulates labeling and advertisement for prescription drugs and medical devices among other things. The advertising for nonprescription or over-the-counter (OTC) drugs falls under the jurisdiction of another federal agency. In pharmaceutical and medical device industry, firms and their representatives distribute or disseminate scientific or medical publications (e.g., journal articles or reference information or texts even including clinical practice guidelines) that discuss off-label uses (unapproved uses) of FDA approved or cleared drugs or medical devices to health care professionals or health care entities. It is imperative that firms stay in compliance with the…

In recent years, the reports and records prescribed by the BSA have also been utilized as tools for investigating individuals suspected of engaging in illegal drug and terrorist financing activities and other Money Laundering activities. Money laundering involves the processing of a financial transaction representing the proceeds of unlawful activity in such a manner to conceal the nature, source, or ownership of the proceeds or to avoid a legal requirement to report such a transaction. This form of fraud differs in many ways from traditional banking fraud since the financial institution is not itself the target; nor are the organization’s…

Leachables are impurities which originate from contact surfaces (typically the final container/closure) of the drug product. As with drug product related impurities it is important to monitor the leachables over the shelf-life of the products to ensure patient safety. Performing leachable stability studies can be challenging and is generally less understood than for typical drug product related impurities. There are several key differences between leachables and drug product related impurities which must be understood in order to design an effective stability program. This presentation will cover: what are leachables, where they come from, what are the similarities and differences in…

In recent years, the reports and records prescribed by the BSA have also been utilized as tools for investigating individuals suspected of engaging in illegal drug and terrorist financing activities and other Money Laundering activities. Money laundering involves the processing of a financial transaction representing the proceeds of unlawful activity in such a manner to conceal the nature, source, or ownership of the proceeds or to avoid a legal requirement to report such a transaction. This form of fraud differs in many ways from traditional banking fraud since the financial institution is not itself the target; nor are the organization’s…

This session will provide the attendee a review of the current enforcement actions, audit focus, privacy, security, and breach issues, and expected regulatory changes in HIPAA, and help the compliance specialist prepare for a year of HIPAA work including responding to issues and planning for regular compliance activities. The most significant issues facing HIPAA professionals will be presented as well as the regular processes that should be in place to help avoid issues in the first place. We will discuss how to consider risk analysis as a means to planning your mitigation activities, and how to plan out dealing with…

Chemical process development is generally not taught as part of degree courses in higher education; the conversion of a synthetic route used for making milligram or gram quantities of a chemical into a process for manufacturing multi-kilogram and tonne quantities is typically learnt "on the job" by chemists in industry. For many years, little chemical development work was published in the literature, until the establishment of the Organic Process R And D journal by Dr Trevor Laird (Founder of Scientific Update). Even now, "tricks of the trade" are handed down within individual company organisations, and it can be difficult to…

QbD is no longer a regulatory initiative; because QbD is good development, QbD is an industry initiative supported by regulators. This course focuses on practical approaches to accelerated QbD implementation, and it makes practical recommendations for realistic implementation of QbD elements. Participants will learn how to prioritize process parameters for screening designs, how to design robust processes using statistical design of experiments (DoE), how to bridge the bench and the commercial design spaces using mixing and scale-up calculations, how to quantify process risk, how to select suitable process analytical technology tools (PAT) and more. Effective technology transfer to pilot and…

Prezado, Gostariamos convida-lo para uma atividade tecnica conosco. Agenda: - 09:30 - Inicio - 10:00 as 11:30 - Apresentacao e labs - Ignite18-UTD-SOP-1.0 - 11:30 as 13:00 - Versao resumida do "Ignite2018-HOW-03-SecurityBestPractices-20180513-final.pdf" Almoco. - 14:30 as 16:00 - Versao demonstrada por nos sem lab do "-Ignite18_HOW-Expedition_LabGuide-20180514.pdf" - 16:00 as 17:30 - Apresentacao e discussao de Cloud com incentive a trial do Expedition Price: price 1: USD 0 Time: 09:30 am to 05:30 pm

The Anthropology & Demography Unit and the Economics Unit of ATINER organize a Stream on “Issues in Economic Anthropology” as part of the 4th Annual International Conference on Anthropology, 18-21 June 2018, Athens, Greece sponsored by the Athens Journal of Social Sciences. This subject has been a significant part of anthropology at least since the founding texts of B. Malinowski, R. Firth, and M. Mauss. Often founded on primary ethnographic fieldwork, research in economic anthropology has contributed greatly to developments in theory and has provided insights that are relevant across disciplines as well as to vital concerns in contemporary global…

The Anthropology & Demography Unit of ATINER organizes a Stream on “Indigenous Rights to Consultation and Self-Determination” as part of the 4th Annual International Conference on Anthropology, 18-21 June 2018, Athens, Greece sponsored by the Athens Journal of Social Sciences. Oppression has marked indigenous people’s history throughout the world, and recognition of rights happened over repeated struggles and acts of resistance. In this context, the Convention 169, emanating from the International Labor Organization in 1989, was a milestone that signified an important progress in terms of the treatment of the indigenous question, especially because the resolution enshrined the right Indigenous…