Health and Medicine

Want to save your organization precious time, money, and improve quality at the same time? Implementing SPC is a great way to get this done. You will learn how…from firsthand experience and examples from companies our Expert has started, and also others where we successfully implemented SPC with enormous benefits. Although SPC has been around for several decades, its application is often erratic, sporadic, and / or lackadaisical. The result is getting a check mark for demonstrating the use of Statistical methods while getting little to no real benefit from the same. SPC can be a great tool when used…

Der Psychiatrie und Psychotherapie Refresher findet vom 21. - 23. Juni 2018 in Berlin statt. In kurzen, 30 – 40 minütigen Blöcken werden die neuesten diagnostischen und therapeutischen Leitlinien der Psychiatrie und Psychotherapie von Spezialisten präsentiert und auf Ihre Fragen eingegangen. Dabei wird vor allem auf Praxisrelevanz großen Wert gelegt. Unsere Referenten sind Experten in ihren Fachbereichen mit langjährer Erfahrung in ihrem Betätigungsfeld. Sie kommen aus renomierten Einrichtungen wie der Charité Universitätsmedizin Berlin, dem Evangelisches Krankenhaus Königin Elisabeth Herberge und der Schlosspark-Klinik Berlin. Diese praxisorientierte Fortbildung bietet in über 24 Stunden: - ein umfassendes Update für Psychiater, Psychologen und Psychotherapeuten…

Neuro Congress 2018 is an elite stage to unite overall eminent researchers in thefield of Neuroscience Brain researchers, public health professionals, scientists, academicscientists, industry researchers, scholars to exchange about state of the artresearch and technologies. The aim of this conference is to stimulate new ideasin the various fields of neurology and neurological research. From brain imaging to neural engineering, this will help in the analysis and selectthe prosthetic to help the patients. Other reasons are, gathering ofworld-class researchers and budding talent from across the globe, showcase yourresearch and get world recognition, avail chances to interact withworld-renowned scientists, perfectly designed schedule:…

The 2018 6th Annual South Spring Hip and Knee Course will bring together a highly esteemed faculty of experts in primary and revision hip and knee procedures, as well as the intricacies of today's healthcare environment. Last year's program was a great success, attracting over 150 healthcare professionals. This will be the premier orthopedic course held in the southeast in 2018. Register now and don’t miss out on this great event. We look forward to seeing you in Key Largo, FL! Time: 2:00 pm - 11:50 pm Prices: Physician: USD 795.0 Allied Health (Nurse, NP, PA, PT, PharmD): USD 300.0…

Course "Writing & Managing Effective SOPs" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Every biopharmaceutical company has SOPs, and new staff members are told that the company "has to have them" and that each employee "has to follow them". But why do there have to be SOPs and why must we follow them as written? And how can we do this effectively? Most people naturally want to do a good job. Successful managers recognize this fact and seek to channel workers' efforts in ways that will…

How does our subjective experience emerge from the brain? How does consciousness relate to the physical world? These age-old, deep questions are now at last being addressed directly and broadly by neuroscience and will become crucial in the decades to come. The spectrum of consciousness-related conundrums is rapidly expanding: we are saving islands of human brain from devastating injuries, growing cerebral organoids in a vat, and building intelligent machines that perform faster and better than any healthy subject, just to mention a few. Where does consciousness arise? Where is the boundary between insentient matter and a spark of subjectivity? Society…

This seminar will provide an exploration of eCTDs and everything that happens before and after your organization produces a regulatory agency eCTD sequence. eCTD format submission delivery mandates exist for FDA submission types. Other agencies (EU, Health Canada…) are imposing eCTD format submission mandates as well. You will gain practical knowledge of the concepts, processes and tools which are utilized to produce submission ready documents, publish technically compliant eCTD sequences, transmit/deliver eCTD sequences, manage the publishing process, support eCTD lifecycle sequences, manage multiple eCTD product dossiers, and archive your eCTDs. Learning Objectives: >. Knowledge of the CTD/eCTD and its propose…

Overview: Medical Device Recalls are an effective method of removing or correcting consumer devices that are in violation of laws administered by the Food and Drug Administration. Recall is a voluntary action that takes place because manufacturers and distributors carry out their responsibility to protect the public health and well-being from devices that present a risk of injury or gross deception or are otherwise defective. Why should you Attend: Recall of medical devices that present a hazard to consumers protects your firm from more severe action by the FDA (or other regulatory agencies). Not performing a recall correctly van lead…

Certainly the most simplistic solution to achieving compliance excellence and 483 avoidances is “to do the right things right!” But what does this really mean? I have distilled the “doing the right things right” solution into 7 separate individual keys or actions that will provide a solid foundation for the establishment of any 483 avoidance program. Why should you attend this Webinar? Because as much as we try, most regulated industries don’t have a set approach for developing a compliance program that is integrated into the fabric of their organization that is targeted to avoiding 483s, that also serves real…

Understand the requirements for investigations when dealing with pharmaceutical drug substances and products; to understand how to effectively control and conduct a laboratory investigation for unknown causes.

When an out of specification or out of trend result is obtained on an active pharmaceutical ingredient or a pharmaceutical product, both ICH and CFR guidance indicates a need for investigation. At times, the root cause is easily identified and the investigation is conducted swiftly. However, when the root cause cannot be easily accessed by initial review, it can be frustrating to determine the appropriate path for the investigation. The recent movement of bringing lean and six sigma projects into industry has had a surprising positive side effect. The tools of lean assessment of issues and problems are also excellent…

Der Allgemeinmedizin Refresher findet vom 20. - 23. Juni 2018 in Berlin statt. Mit über 5.000 teilnehmenden Ärzten zählen unsere Fortbildungen im Bereich Allgemeinmedizin und Innere Medizin zu den beliebtesten Kursen im deutschsprachigen Raum. In kurzen, 30 – 40 minütigen Blöcken werden die neuesten diagnostischen und therapeutischen Leitlinien der Allgemeinmedizin von Spezialisten präsentiert und auf Ihre Fragen eingegangen. Dabei wird vor allem auf Praxisrelevanz und Didaktik großen Wert gelegt. Unsere Referenten sind Experten in ihren Fachbereichen mit langjähriger Erfahrung in ihrem Betätigungsfeld. Sie kommen aus renommierten Einrichtungen wie der Charité, dem Universitätsklinikum Leipzig, dem Klinikum Ernst von Bergmann Potsdam oder…

Hospital care models are transforming, and nurse practitioners and physician assistants play vital roles in the care delivery of hospitalized patients. Hospital Medicine for NPs and PAs fills your CME needs. Course Highlights - 25.25 AMA PRA Category 1 Credits™ - 25.25 ANCC Contact Hours - 10.5 Hours designated pharmacology content - Pharmacology Workshop - Critical Care Breakout - Contemporary guideline-based best practices - Clinical care pathways - Diagnostic and treatment algorithms - Common clinical dilemmas - Practicing health care provider faculty Price: Registration - General Session:USD 600.0 Time: 7:00 am to 5:00 pm

Course "Preparation of FDA Submissions and Communicating with the FDA (INDs, NDAs, BLAs, ANDAs, PMAs, 510(k)s, IDEs, Post-Approval Supplements)" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Why you should attend: • What do the regulations say? • Navigate the FDA drug and device approval system • Prepare, construct and submit well-written IND, NDA, BLA, PMA, 510(k) and IDE submissions and regulatory filings • Navigate the FDA review process • Identify the required regulations and guidance documents for drug and biologic submissions • Use regulations and guidance…

Overview: FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based company-wide V&V planning. Starting with a Master Validation Plan, evaluating its elements against ISO 14971 hazard analysis / risk management, allows development of meaningful product validations. The roles of different V&V protocols. How to employ equipment / process DQs, IQs, OQs, and PQs, or their equivalents per ASTM E2500, against a background of limited company resources (personnel, budget, time). A matrix simplifies "as-product", "in-product", process, and equipment, et al, software V&VT, assuring key FDA requirements…

There are many different types of microbial contamination that can occur in pharmaceutical manufacturing. Some of the sources include: water, raw materials, excipients, in-process materials and samples, the manufacturing process, the product itself, and the general manufacturing environment. As such, there is no one size fits all investigation. Microbiological testing covers a wide range of products, processes and environments, therefore representative samples from each of these categories forms the basis of what gets investigated. Why You Should Attend: Medical device regulations in the US and the EU are foundational to the remainder of the regulations that are applied to medical…

This webinar details the methodology and related requirements adopted by CMS for developing a revised Medicare Clinical Laboratory Fee Schedule (CLFS) using rates paid by private health insurance companies, Medicaid Managed Care Organizations and Medicare Advantage plans. Key changes covered include the market-based data approach that Medicare uses to set payment rates; the switchover to a national fee schedule creating a single payment rate nationwide for each test without local variation; and the creation of a new category of tests, Advanced Diagnostic Laboratory Tests (ADLTs) and the different pricing methods and reporting periods for existing and new ADLTs. An analysis…

Biotech Outsourcing Strategies is a leading RandD outsourcing-partnering event. The expanded scope in 2018 will include Discovery Outsourcing in addition to CMC Outsourcing for both small molecules and biologics. Established in 2006 the event formula includes 4 key components as follows: Presentations - Delivered by thought leaders in the industry. Organisations who will be presenting include international Pharmaceutical companies such as Roche, Novartis, Bayer but also SME biotech and service providers who play a key role in developing new therapeutics: 1-to-1 Partnering - Facilitated by our partnering software, partnering allows stakeholders to connect, discuss outsourcing opportunities and build relationships: Exhibition…

The HPAPI Summit brings together perspectives throughout the value chain from bench to outsource, providing you with a unified outlook on the latest developments in highly potent manufacturing. As compounds become increasingly potent, the need for harmonization among distinct groups within organizations around key challenges is more acute than ever before. By involving multiple perspectives from companies of different size and experience in the field, the HPAPI Summit will enable you to understand how you can implement safe and robust practices in your own organization. Incorporating insights from Genentech, Pfizer, Vertex, SafeBridge and Boehringer Ingelheim, you will leave this conference…

As the knowledge of the microbiome continues to deepen, fundamental understanding of mechanism of action and demonstrating causality continue to improve. As such, the Microbiome Movement has become more committed than ever to work alongside innovative researchers and industry leaders to build events that focus on applied science and translate cutting edge microbiome R&D into safe, effective and commercially successful products across a number of industry-specific verticals. Positioned at the heart of pharmaceutical, agricultural, nutritional and animal health R&D, the Microbiome Movement continues to help accelerate the discovery, development and delivery of breakthrough solutions to global challenges to benefit human…